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A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734) in Participants With Severe COVID-19

Trial Profile

A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734) in Participants With Severe COVID-19

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Mar 2021

At a glance

  • Drugs Remdesivir (Primary)
  • Indications COVID 2019 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms SIMPLE; SIMPLE-severe
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 10 Mar 2021 Results assessing final comparative analysis from two studies: a prospective phase 3, randomized study of RDV (n=368; RDV cohort- final Day 28 (D28) analysis of NCT04292899) vs standard of care (SOC) (n= 1399; interim Day 14 [D14] analysis of a real-world retrospective cohort study of SOC (non-RDV cohort), presented at the 28th Conference on Retroviruses and Opportunistic Infections
    • 25 Oct 2020 Results (n=397) assessing regional differences in clinical outcomes of severe COVID-19 patients treated with RDV, presented at the IDWeek 2020
    • 22 Oct 2020 According to a Gilead Sciences media release, the U.S. Food and Drug Administration (FDA) has approved Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization, based on data from ACTT-1 and SIMPLE-Severe studies.

Trial Overview

Purpose

This phase III study is designed to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to the normalization of temperature and oxygen saturation through Day 14 in participants with severe coronavirus disease (COVID-19).

Comments

According to a Gilead Sciences media release, the U.S. Food and Drug Administration (FDA) has approved Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization, based on data from ACTT-1 and SIMPLE-Severe studies.

According to a European Medicines Agency media releas, EMA has now received an application for conditional marketing authorisation (CMA) of the antiviral medicine remdesivir for the treatment of COVID-19 and has formally started its evaluation. The assessment of the benefits and risks of remdesivir is being performed under a reduced timeline and an opinion could be issued within weeks, depending on the robustness of the data submitted and whether further information is required to support the evaluation.
According to an Emalex Biosciences media release, EMA's human medicines committee (CHMP) has recommended expanding the compassionate use of the investigational medicine remdesivir so that more patients with severe COVID-19 can be treated. The updated recommendations are based on preliminary results from the NIAID-ACTT study, which suggest a beneficial effect of remdesivir in the treatment of hospitalised patients with severe COVID-19.EMA is currently evaluating these data in the context of the rolling review of remdesivir.In addition to patients undergoing invasive mechanical ventilation, the compassionate use recommendations now cover the treatment of hospitalised patients requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or ECMO (extracorporeal membrane oxygenation).A treatment duration of 5 days has been introduced alongside the longer 10-day course, based on preliminary results from this study (GS-US-540-5773) suggesting that for patients not requiring mechanical ventilation or ECMO, the treatment course may be shortened from 10 to 5 days without any loss of efficacy.Patients who receive a 5-day treatment course but do not show clinical improvement will be eligible to continue receiving remdesivir.Although remdesivir is not yet authorised for marketing in the European Union, these recommendations for compassionate use will help some patients with severe COVID-19 access the medicine while EMA evaluates data on its benefits and risks. When the evaluation is complete, EMA will make a recommendation on whether or not remdesivir should receive a marketing authorisation (as of 11th May 2020).

The Japanese Ministry of Health, Labour and Welfare (MHLW) granted regulatory approval of Veklury (remdesivir) as a treatment for SARS-CoV-2 infection under an exceptional approval pathway. The exceptional approval was granted due to the COVID-19 pandemic and references the Emergency Use Authorization of remdesivir in the United States. The approval is based on clinical data from the U.S. National Institute of Allergy and Infectious Diseases's global Phase 3 trial, the company's Phase 3 SIMPLE trial in patients with severe manifestations of COVID-19, and available data from company's compassionate use program, including patients in Japan.
According to a Gilead Sciences media release, the U.S. FDA granted emergency use authorization (EUA) for the investigational antiviral remdesivir to treat COVID-19. The EUA will facilitate broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease, enabling access to remdesivir at additional hospitals across the country. Under the EUA, both 5-day and 10-day treatment durations are suggested, based on the severity of disease.The EUA is based on available data from two global clinical trials, the National Institute for Allergy and Infectious Diseases placebo-controlled Phase 3 study in patients with moderate to severe symptoms of COVID-19 (NCT04280705), including those who were critically ill, and Gileads global Phase 3 study evaluating 5-day and 10-day dosing durations of remdesivir in patients with severe disease (NCT04292899).The EUA is temporary and does not take the place of the formal new drug application submission, review and approval process. The EUA allows for the distribution and emergency use of remdesivir only for the treatment of COVID-19, remdesivir remains an investigational drug and has not been approved by FDA.

Primary Endpoints

Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14

description: Clinical status was derived from death, hospital discharge, and the ordinal scale as follows: score of "1" was used for all days on or after the date of death; score of "7" was used for all days on or after discharged alive date; last assessment carried forward for any missing values.The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring low flow supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol remdesivir administration); 7. Not hospitalized. The odds ratio represents the odds of improvement in the ordinal scale for the Remdesivir for 10 days group vs the Remdesivir for 5 days group.
time_frame: Day 14

Other Endpoints

Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)

description: Treatment-emergent Adverse Events (TEAE) were defined as AEs with onset dates on or after the study treatment start date and no later than 30 days after the permanent discontinuation of the study treatment and/or the AEs that led to premature discontinuation of study treatment.
time_frame: First dose date up to last dose date (maximum: 10 days) plus 30 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 6000

    Actual: 4891

  • Sex male & female
  • Age Group ≥ 12 years; adolescent; adult; child; elderly

Patient Inclusion Criteria

Key - Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥ 18), or willing and able to provide assent (age ≥ 12 to < 18, where locally and nationally approved) prior to performing study procedures - Aged ≥ 18 years (at all sites), or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC)) - Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization - Currently hospitalized - Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen at screening Key

Patient Exclusion Criteria

- Participation in any other clinical trial of an experimental treatment for COVID-19 - Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing - Evidence of multiorgan failure - Mechanically ventilated [including veno-venous (V-V) extracorporeal membrane oxygenation (ECMO)] ≥ 5 days, or any duration of veno-arterial (V-A) ECMO. - Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN) - Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants ≥ 18 years of age {Cockcroft 1976} and Schwartz Formula for participants < 18 years of age Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial Details

Identifiers

Identifier Owner
NCT04292899 ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-000841-15 European Clinical Trials Database
GS-US540-5773 Gilead Sciences
ISRCTN15874265 ISRCTN: Current Controlled Trials

Organisations

  • Sponsors Gilead Sciences
  • Affiliations Gilead Sciences

Trial Dates

  • Initiation Dates

    Planned : 01 Mar 2020

    Actual : 06 Mar 2020

  • Primary Completion Dates

    Planned : 01 Jun 2020

    Actual : 09 Apr 2020

  • End Dates

    Planned : 01 Jun 2020

    Actual : 30 Jun 2020

Substudies/Extensions

An expansion phase of the study was added to enroll up to 5,600 additional patients, including those on mechanical ventilation.

Other Details

  • Design multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase III
  • Location China; England; France; Germany; Hong Kong; Italy; Japan; Netherlands; Scotland; Singapore; South Korea; Spain; Sweden; Switzerland; Taiwan; United Kingdom; USA
  • Focus Registrational; Therapeutic Use

Interventions

Drugs Route Formulation
RemdesivirPrimary Drug Intravenous Infusion, Lyophilised

Part A: Remdesivir (RDV), 5 Days

Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, and 5. Drug: Remdesivir (Administered as an intravenous infusion) Other Name: GS-5734™, Veklury® Drug: Standard of Care (Standard of Care Treatment for COVID-19 Infection)

Part A: Remdesivir, 10 Days

Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10. Drug: Remdesivir (Administered as an intravenous infusion) Other Name: GS-5734™, Veklury® Drug: Standard of Care (Standard of Care Treatment for COVID-19 Infection)

Part B: Remdesivir 10 days (Mechanically Ventilated)

Participants on mechanical ventilation will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10 Drug: Remdesivir (Administered as an intravenous infusion) Other Name: GS-5734™, Veklury® Drug: Standard of Care (Standard of Care Treatment for COVID-19 Infection)

Part B: Remdesivir, 10 Days (Extension)

Part B (Extension) will enroll participants after enrollment to Part A is complete. Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10. Drug: Remdesivir (Administered as an intravenous infusion) Other Name: GS-5734™, Veklury® Drug: Standard of Care (Standard of Care Treatment for COVID-19 Infection)

Results

Therapeutic efficacy

Updated results from the phase III SIMPLE-severe trial for COVID-19 infections showed that clinical outcomes varied by geography. Increased mortality and lower rate of clinical improvement, were observed in patients from Italy compared with other regions. At day 14, the overall mortality rate was 7% and 18% for all other countries and Italy, respectively. Clinical improvement at day 14, measured as ≥2-point increase in the ordinal scale, was lower in Italian patients (39%) versus all other countries combined (64%). The overall results showed that 5day remdesivir treatment was as effective as 10days. In a multivariable model, 5/10d remdesivir was significantly positively associated with clinical improvement (adjusted odds ratio [OR] 1.69, 95% CI: 1.08, 2.65; p = 0.0226). Age < 65y (p < 0.0001) and region of treatment (Europe and NA vs Asia, p< 0.0001 each were the significant covariables positively associated with clinical improvement. Other factors that were not significantly associated with clinical improvement, included gender, race, ethnicity, baseline oxygen support, duration of symptoms and hospitalization, obesity, and baseline transaminase levels. Earlier data showed significant improvement in clinical recovery and a 62 percent reduction was observed in the risk of mortality in comparison to standard of care. Recovery was observed in 74.4% remdesivir treated patients on day 14 in comparison to 59% patients receiving standard of care. The mortality rate for patients treated with remdesivir in the analysis was observed to be 7.6% at day 14 in comparison to 12.5% patients not taking remdesivir (adjusted odds ratio 0.38, 95% confidence interval 0.22-0.68, p=0.001). Median follow-up of 14 days, the rates and likelihood of recovery were observed to be lower in patients who received concomitant hydroxychloroquine in comparison to patients treated with remdesivir who did not receive hydroxychloroquine (57 percent vs. 69 percent, covariate-adjusted HR [95% CI] 0.61 [0.45, 0.83], p=0.002). In an exploratory analysis, patients in the study who received remdesivir within 10 days of symptom onset had improved outcomes compared with those treated after more than 10 days of symptoms. Five and 10 day treatment course showed similar outcomes (odds ratio 0.75; 95% CI, 0.51 to 1.12) [2] . Pooling data across treatment arms, by day 14, 62% patients treated early were able to be discharged from the hospital, compared with 49% patients who were treated late [3] [4] [5] .

Adverse events

Treatment with remdesivir in a phase III SIMPLE-severe trial for COVID-2019 infections showed that the drug was generally well-tolerated in both the 5-day and 10-day treatment groups. The most common adverse events (AE) occurring in more than 10% of patients in either group were nausea (5-day: 10.0%, n=20/200 vs. 10-day: 8.6%, n=17/197) and acute respiratory failure (5-day: 6.0%, n=12/200 vs. 10-day: 10.7%, n= 21/197). Grade 3 or higher liver enzyme (ALT) elevations occurred in 7.3% in 10 days group and 2% in 5 days group, with 3% of patients discontinuing remdesivir treatment due to elevated liver tests. Also, AST increase in 5 days vs 10 days group was 3% vs 6% respectively. Study drug-related serious adverse event were observed in 2% patients in both groups. AE leading to discontinuation were observed in 5% and 10% patients in 5 day and 10 day groups respectively [2] [5] .

Publications

  1. Diaz G, Arribas JR, Robinson PA, Cattelan AM, Tashima KT, Tsang OT-Y, et al. Geographical Disparities in Clinical Outcomes of Severe COVID-19 Patients Treated with Remdesivir. IDW-2020 2020; abstr. N/A.

    Available from: URL: https://www.eventscribe.net/2020/IDWeek/fsPopup.asp?Mode=presInfo&PresentationID=775582
  2. Gilead Sciences. Gilead Presents Additional Data on Investigational Antiviral Remdesivir for the Treatment of COVID-19. Media-Rel 2020;.

    Media Release
  3. Gilead Sciences. Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19. Media-Rel 2020;.

    Media Release
  4. Goldman JD, Lye DCB, Hui DS, Marks KM, Bruno R, Montejano R, et al. Remdesivir for 5 or 10 Days in Patients with Severe Covid-19. . N-Engl-J-Med 2020;.

    PubMed | CrossRef Fulltext
  5. Olender S, Walunas TL, Martinez E, Boffito M, Perez KK, Castagna A, et al. Remdesivir Versus Standard of Care for Severe Covid-19. CROI-2021 2021; abstr. 393.

    Available from: URL: http://www.croiconference.org/

Authors

Author Total Publications First Author Last Author
Ahn MY 1 - -
Arribas JR 1 - -
Bernardino JI 1 - -
Blair C 2 - -
Boffito M 1 - -
Brainard D 1 - 1
Brainard DM 2 - -
Bruno R 1 - -
Cao H 1 - -
Castagna A 1 - -
Cattelan AM 1 - -
Chen Y-S 1 - -
Chen YS 1 - -
Chin BS 1 - -
Chokkalingam A 1 - -
Chokkalingam AP 1 - -
Criner GJ 1 - -
Diaz G 2 1 -
Diaz-Cuervo H 1 - -
Gaggar A 1 - -
Galli M 1 - -
Gilead Sciences 2 2 2
Goldman JD 1 1 -
Gottlieb RL 1 - 1
Goyal P 1 - -
Haubrich RH 1 - -
Hui DS 1 - -
Hyland RH 1 - -
Lye DCB 2 - -
Marks KM 1 - -
Martinez E 1 - -
Marty FM 1 - -
Montejano R 1 - -
Mullane KM 1 - -
Munoz J 2 - -
Nahass RG 1 - -
Olender S 1 1 -
Osinusi A 1 - -
Osinusi AO 1 - -
Perez KK 1 - -
Ripamonti D 1 - -
Robinson PA 1 - -
SenGupta D 2 - -
Spinner C 1 - -
Spinner CD 1 - -
Subramanian A 1 - 1
Tashima KT 2 - -
Towner WJ 1 - -
Tsang OT-Y 1 - -
Vendrame E 1 - -
Walunas TL 1 - -
Wang S 1 - -
Wei X 1 - -
Wu G 1 - -

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
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Academisch Medisch Centrum Amsterdam, Alta Bates Summit Medical Center, ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia, ASST di Cremona - Azienda Socio Sanitaria, ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco, ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa, Azienda Ospedaliera Di Padova, Azienda Ospedaliero Universitaria di Parma, Baylor Scott & White All Saints Medical Center, Baylor Scott & White Medical Center -Temple, Baylor University Medical Center, Beth Israel Deaconess Medical Center, Brigham and Womens Hospital, California Pacific Medical Center, Castle Hill Hospital, Charité - Universitätsmedizin Berlin, CHU Gui De Chauliac, Columbia University Medical Center, Comprensorio Amedeo Di Savoia Birago Di Vische, Danbury Hospital, Dartmouth-Hitchcock Medical Center, Derriford Hospital, Downey Medical Center, Duke University Medical Center, Eden Medical Center, Erasmus MC, Fondazione IRCCS, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Fontana Medical Center, Franciscan Health System Research Center, Hackensack University Medical Center, Hennepin Healthcare Research Institute, Henry Ford Hospital, Hoag Memorial Hospital Presbyterian, Holy Cross Hospital, Hopitaux Universitaires de Geneve (HUG),, Hospital Clinic de Barcelona, Hospital of the University of Pennsylvania, Hospital Regional Universitario de Malaga – Hospital General, Hospital Universitari i Politecnic La Fe de Valencia, Hospital Universitario 12 de Octubre, Hospital Universitario A Coruña, Hospital Universitario de Bellvitge, Hospital Universitario de Cruces, Hospital Universitario Fundacion Jimenez Diaz, Hospital Universitario La Paz – PPDS, Hospital Universitario Principe de Asturias, Hospital Universitario Ramon y Cajal, Hospital Universitario Vall d'Hebrón – PPDS, Hospital Universitario Virgen del Rocio – PPDS, Houston Methodist Hospital, Hôpital Saint Antoine, Hôpital Saint Louis, Hôpital Saint-André, Hôtel Dieu – Nantes, Icahn School of Medicine at Mount Sinai, Indiana University School of Medicine-Indianapolis, Inland Northwest Research, Inova Fairfax Hospital, Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS, Jacobi Medical Center, Jamaica Hospital Medical Center, James J Peters Veterans Administration Medical Center – NAVREF, John H. Stroger, Jr. Hospital of Cook County, Kadlec Regional Medical Center, Kaiser Permanente, Kaiser Permanente Center For Health Research, Kaiser Permanente Los Angeles Medical Center, Kaiser Permanente Oakland Medical Center, Kaiser Permanente San Francisco Medical Center, Kaiser Permanente San Jose Medical Center, Kaiser Permanente San Leandro Medical Center, Kaiser Permanente Santa Clara, Kaiser Permanente South San Francisco Medical Center, Kaohsiung Veterans General Hospital, Karolinska University Hospital, Kiaser Westside Medical Center, King's College Hospital NHS Foundation Trust, Klinikum rechts der Isar der Technischen Universität München, Klinikum Schwabing, Klinikum St. Georg gGmbH, Leids Universitair Medisch Centrum, Liver Institute at Methodist Dallas, Long Island Jewish Medical Center, Maine Medical Center, Manchester Royal Infirmary – PPDS, Mayo Clinic – PPDS, Mills Peninsula Medical Center, Miriam Hospital, Mission Hospital, Moreno Valley Medical Center, Mount Sinai Beth Israel, Mount Sinai Morningside, Mount Sinai West, National Centre for Infectious Diseases, National Medical Center, National Taiwan University Hospital, National University Hospital, New York Presbyterian Hospital - Weill-Cornell, Newark Beth Isreael Medical Center, North Manchester General Hospital – PPDS, Northwell Health,, Northwick Park Hospital, Ontario Medical Center, Orange County Anaheim Medical Center, Ospedale Guglielmo Da Saliceto, Ospedale Regionale Lugano Civico, Ospedale San Raffaele S.r.l. – PPDS, Panorama City Medical Center, Prince of Wales Hospital, Prisma Health-Greenville Memorial Hospital, Prisma Health–Midlands, Providence Regional Medical Center Everett, Providence Saint Patrick Hospital, Providence Saint Vincent's Medical Center, Providence St Peter Hospital, Providence St. John’s Health Center, Queen Elizabeth University Hospital – PPDS, Queen Mary Hospital, Riverside Medical Center, Robert Bosch Krankenhaus, Robert Wood Johnson University Hospital New Brunswick, Rose Medical Center, Royal Free London NHS Foundation Trust, Royal Hallamshire Hospital, Royal Infirmary of Edinburgh – PPDS, Royal Lancaster Infirmary, Royal Liverpool University Hospital, Rush University Medical Center, Sahlgrenska Universitetssjukhuset, San Diego Medical Center, Seoul Medical Center, Singapore General Hospital (SGH), Skånes Universitetssjukhus Malmö, Somerset Medical Center, South Bay Medical Center, St Joseph Hospital – Eureka, St Joseph's Regional Medical Center, St Mary's Hospital, St.Joseph Hospital – Orange, Stanford University School of Medicine, Sutter Medical Center Sacramento, Sutter Roseville Medical Center, Sutter Santa Rosa Regional Hospital, Swedish Medical Center, Tacoma General Hospital, Temple University Hospital, Tokyo Metropolitan Bokutoh Hospital, Tufts Medical Center – PPDS, Tulane University School of Medicine, Universitatsklinikum, Universitatsklinikum Schleswig-Holstein, University College London Hospitals (UCLH), University Hospitals Cleveland Medical Center, University of Chicago, University of Colorado, University Of Iowa Hospitals And Clinics, University of Michigan, University of Utah – PPDS, Universitätsklinikum Hamburg Eppendorf, Universitätsspital Zürich, UT Southwestern Medical Center–ID Clinical Reseach, UT Southwestern Medical Center–ID Clinical Research, Virginia Commonwealth University, Virginia Hospital Center, Virginia Mason Medical Center, West Los Angeles Medical Center, Woodland Hills Medical Center, Yale-New Haven Hospital, Yokohama Municipal Citizen’s Hospital, Zion Medical Center France, Germany, Hong-Kong, Italy, Japan, Netherlands, Singapore, South-Korea, Spain, Sweden, Switzerland, Taiwan, United-Kingdom, Uruguay, USA
Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com
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Gilead Sciences USA
Gilead Study Director Gilead Sciences USA
Ms Devi Sengupta
333 Lakeside Drive Foster City California 94404 United States of America +1 646-351-9642 Devi.SenGupta@gilead.com
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333 Lakeside Drive USA

Centres

Centre Name Location Trial Centre Country
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France
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Germany
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Hong-Kong
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Italy
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Japan
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Netherlands
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Singapore
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South-Korea
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Spain
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Sweden
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Switzerland
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Taiwan
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United-Kingdom
333 Lakeside Drive California USA
Academisch Medisch Centrum Amsterdam Amsterdam, Noord-Holland Netherlands
Alta Bates Summit Medical Center Berkeley, California USA
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia Pazzale Spedali Civili 1,U.O. di Malattie Infettive, Brescia Italy
ASST di Cremona - Azienda Socio Sanitaria Cremona,Lombardia Italy
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco Dipartimento di Scienze Biomediche e Cliniche L. Sacco,MilanoLombardia Italy
ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII,Piazza OMS 1,Bergamo Italy
Azienda Ospedaliera Di Padova Padova,Veneto Italy
Azienda Ospedaliero Universitaria di Parma Parma Italy
Baylor Scott & White All Saints Medical Center Fort Worth, TX USA
Baylor Scott & White Medical Center -Temple Temple, TX USA
Baylor University Medical Center Dallas, Texas USA
Beth Israel Deaconess Medical Center Boston, Massachusetts USA
Brigham and Womens Hospital Brigham and Women's Hospital, Boston, Massachusetts USA
California Pacific Medical Center California USA
Castle Hill Hospital Cottingham United-Kingdom
Charité - Universitätsmedizin Berlin Berlin Germany
CHU Gui De Chauliac 80, avenue Augustin Fliche, Montpellier, France
Columbia University Medical Center PH E101, New York USA
Comprensorio Amedeo Di Savoia Birago Di Vische Torino,Piemonte Italy
Danbury Hospital Danbury, Connecticut Uruguay
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire USA
Derriford Hospital Plymouth United-Kingdom
Downey Medical Center Downey, CA USA
Duke University Medical Center Durham, North Carolina USA
Eden Medical Center California USA
Erasmus MC Rotterdam Netherlands
Fondazione IRCCS Pavia Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano,Lombardia Italy
Fontana Medical Center Fontana, CA USA
Franciscan Health System Research Center Tacoma, Washington USA
Gilead Sciences
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Gilead Sciences
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Gilead Sciences
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USA
Hackensack University Medical Center New Jersey USA
Hennepin Healthcare Research Institute Minneapolis, Minnesota USA
Henry Ford Hospital Detroit, Michigan USA
Hoag Memorial Hospital Presbyterian California, USA
Holy Cross Hospital Silver Spring, Maryland USA
Hopitaux Universitaires de Geneve (HUG), 4 Rue Gabrielle Perret-Gentil, Geneve Switzerland
Hospital Clinic de Barcelona Barcelona Spain
Hospital of the University of Pennsylvania Philadelphia, Pennsylvania USA
Hospital Regional Universitario de Malaga – Hospital General Servicio de Enfermedades Infecciosas,Malaga Spain
Hospital Universitari i Politecnic La Fe de Valencia Valencia Spain
Hospital Universitario 12 de Octubre Madrid Spain
Hospital Universitario A Coruña A Coruña Spain
Hospital Universitario de Bellvitge Barcelona Spain
Hospital Universitario de Cruces Unidad enfermedades infecciosas,Barakaldo Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Universitario La Paz – PPDS Paseo de la Castellana 261, Madrid Spain
Hospital Universitario Principe de Asturias Carretera de Alcala Meco s/n, Madrid Spain
Hospital Universitario Ramon y Cajal Ctra. de Colmenar, Km. 9,100, Madrid Spain
Hospital Universitario Vall d'Hebrón – PPDS Barcelona Spain
Hospital Universitario Virgen del Rocio – PPDS Avenida Manuel Siurot s/n, Sevilla Spain
Houston Methodist Hospital Texas USA
Hôpital Saint Antoine Paris, France
Hôpital Saint Louis Paris, France
Hôpital Saint-André Bordeaux France
Hôtel Dieu – Nantes Loire-Atlantique France
Icahn School of Medicine at Mount Sinai 8th Floor, New York USA
Indiana University School of Medicine-Indianapolis Indiana USA
Inland Northwest Research Suite500,Spokane,Washington USA
Inova Fairfax Hospital Falls Church, Virginia USA
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS Roma Italy
Jacobi Medical Center 1400 Pelham Parkway South, Bronx, New York USA
Jamaica Hospital Medical Center New York USA
James J Peters Veterans Administration Medical Center – NAVREF 130 West Kingsbridge Road, Bronx, New York USA
John H. Stroger, Jr. Hospital of Cook County Illinois USA
Kadlec Regional Medical Center Washington USA
Kaiser Permanente Denver, CO USA
Kaiser Permanente Center For Health Research Oregon USA
Kaiser Permanente Los Angeles Medical Center 4867 West Sunset Boulevard, Los Angeles, California USA
Kaiser Permanente Oakland Medical Center Oakland, California USA
Kaiser Permanente San Francisco Medical Center 2425 Geary Blvd. San Francisco, CA USA
Kaiser Permanente San Jose Medical Center 250 Hospital Parkway, San Jose, CA USA
Kaiser Permanente San Leandro Medical Center 2500 Merced Street San Leandro, CA USA
Kaiser Permanente Santa Clara 700 Lawrence Expressway, Santa Clara, CA USA
Kaiser Permanente South San Francisco Medical Center 1200 El Camino Real, San Francisco, CA USA
Kaohsiung Veterans General Hospital Kaohsiung City Taiwan
Karolinska University Hospital Stockholm Sweden
Kiaser Westside Medical Center 2875 NW Stucki Ave., Hillsboro, OR USA
King's College Hospital NHS Foundation Trust London United-Kingdom
Klinikum rechts der Isar der Technischen Universität München Bayern Germany
Klinikum Schwabing Bayern Germany
Klinikum St. Georg gGmbH Sachsen Germany
Leids Universitair Medisch Centrum Leiden Netherlands
Liver Institute at Methodist Dallas Texas USA
Long Island Jewish Medical Center New Hyde Park, NY USA
Maine Medical Center Portland, Maine USA
Manchester Royal Infirmary – PPDS Manchester United-Kingdom
Mayo Clinic – PPDS Minnesota USA
Mills Peninsula Medical Center California USA
Miriam Hospital Rhode Island USA
Mission Hospital California USA
Moreno Valley Medical Center Moreno Valley, CA USA
Mount Sinai Beth Israel 350 East 17th Street, 3rd floor, New York USA
Mount Sinai Morningside 440 West 114th Street, 6th floor, New York, NY USA
Mount Sinai West 1000 10th Avenue, Suite 2T, New York, NY USA
National Centre for Infectious Diseases 16 Jalan Tan Tock Seng Singapore
National Medical Center Seoul, 4564 South-Korea
National Taiwan University Hospital Hsinchu Taiwan
National University Hospital 119228 Singapore
New York Presbyterian Hospital - Weill-Cornell New York USA
Newark Beth Isreael Medical Center Newark, NJ USA
North Manchester General Hospital – PPDS Manchester United-Kingdom
Northwell Health, Manhasset, New York USA
Northwick Park Hospital London United-Kingdom
Ontario Medical Center Ontario, CA USA
Orange County Anaheim Medical Center Anaheim, CA USA
Ospedale Guglielmo Da Saliceto Piacenza, Emilia-Romagna Italy
Ospedale Regionale Lugano Civico Ticino (it), Switzerland
Ospedale San Raffaele S.r.l. – PPDS Via Olgettina 60, Isituto Scientifico Universitario San Raffaele,Milano Italy
Panorama City Medical Center Panorama City, CA USA
Prince of Wales Hospital Sha Tin Hong-Kong
Prisma Health-Greenville Memorial Hospital Greenville, SC USA
Prisma Health–Midlands South Carolina USA
Providence Regional Medical Center Everett Everett, Washington, USA
Providence Saint Patrick Hospital Montana USA
Providence Saint Vincent's Medical Center Oregon USA
Providence St Peter Hospital Washington USA
Providence St. John’s Health Center California USA
Queen Elizabeth University Hospital – PPDS Glasgow United-Kingdom
Queen Mary Hospital Kowloon Hong-Kong
Riverside Medical Center Riverside, CA USA
Robert Bosch Krankenhaus Stuttgart Germany
Robert Wood Johnson University Hospital New Brunswick New Brunswick, NJ USA
Rose Medical Center Denver, Colorado USA
Royal Free London NHS Foundation Trust London United-Kingdom
Royal Hallamshire Hospital Sheffield United-Kingdom
Royal Infirmary of Edinburgh – PPDS Edinburgh United-Kingdom
Royal Lancaster Infirmary Lancaster United-Kingdom
Royal Liverpool University Hospital Liverpool United-Kingdom
Rush University Medical Center Illinois USA
Sahlgrenska Universitetssjukhuset Vastra Gotalands lan Sweden
San Diego Medical Center San Diego, CA USA
Seoul Medical Center Seoul, 2053 South-Korea
Singapore General Hospital (SGH) 20 College Road Singapore
Skånes Universitetssjukhus Malmö Malmö Sweden
Somerset Medical Center Somerville, New Jersey USA
South Bay Medical Center Harbor City, CA USA
St Joseph Hospital – Eureka California USA
St Joseph's Regional Medical Center Paterson, New Jersey USA
St Mary's Hospital London United-Kingdom
St.Joseph Hospital – Orange Orange,California USA
Stanford University School of Medicine Stanford, California USA
Sutter Medical Center Sacramento Sacramento, California USA
Sutter Roseville Medical Center Roseville, CA USA
Sutter Santa Rosa Regional Hospital Santa Rosa, California USA
Swedish Medical Center Seattle, Washington, USA
Tacoma General Hospital 315 Martin Luther King Jr Way ,Tacoma, Washington USA
Temple University Hospital Pennsylvania USA
Tokyo Metropolitan Bokutoh Hospital Toyko Japan
Tufts Medical Center – PPDS Massachusetts USA
Tulane University School of Medicine Louisiana USA
Universitatsklinikum Dusseldorf, Moorenstraße 5, Düsseldorf Germany
Universitatsklinikum Schleswig-Holstein Kiel Germany
University College London Hospitals (UCLH) London United-Kingdom
University Hospitals Cleveland Medical Center Cleveland, Ohio USA
University of Chicago Chicago, Illinois USA
University of Colorado Denver, Colorado USA
University Of Iowa Hospitals And Clinics Iowa City, Iowa USA
University of Michigan Michigan USA
University of Utah – PPDS Salt Lake City, Utah USA
Universitätsklinikum Hamburg Eppendorf I. Medizinische Klinik und Poliklinik,Hamburg Germany
Universitätsspital Zürich Zürich Switzerland
UT Southwestern Medical Center–ID Clinical Reseach Dallas, TX USA
UT Southwestern Medical Center–ID Clinical Research Dallas, TX USA
Virginia Commonwealth University Richmond, Virginia USA
Virginia Hospital Center Arlington, Virginia USA
Virginia Mason Medical Center Seattle, Washington USA
West Los Angeles Medical Center 6041 Cadillac Avenue, Los Angeles, CA USA
Woodland Hills Medical Center 5601 De Soto Avenue, Woodland Hills, CA USA
Yale-New Haven Hospital Connecticut USA
Yokohama Municipal Citizen’s Hospital 221-0855 Japan
Zion Medical Center 4647 Zion Avenue, San Diego, CA USA

Trial History

Event Date Event Type Comment
10 Mar 2021 Results Results assessing final comparative analysis from two studies: a prospective phase 3, randomized study of RDV (n=368; RDV cohort- final Day 28 (D28) analysis of NCT04292899) vs standard of care (SOC) (n= 1399; interim Day 14 [D14] analysis of a real-world retrospective cohort study of SOC (non-RDV cohort), presented at the 28th Conference on Retroviruses and Opportunistic Infections Updated 21 Apr 2021
04 Jan 2021 Other trial event Last checked against ClinicalTrials.gov record. Updated 04 Jan 2021
30 Nov 2020 Other trial event Last checked against European Clinical Trials Database record. Updated 30 Nov 2020
25 Oct 2020 Results Results (n=397) assessing regional differences in clinical outcomes of severe COVID-19 patients treated with RDV, presented at the IDWeek 2020 Updated 17 Dec 2020
22 Oct 2020 Other trial event According to a Gilead Sciences media release, the U.S. Food and Drug Administration (FDA) has approved Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization, based on data from ACTT-1 and SIMPLE-Severe studies. Updated 27 Oct 2020
10 Aug 2020 Other trial event According to an Gilead Sciences media release, it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Veklury (remdesivir), an investigational antiviral for the treatment of patients with COVID-19.The filing is supported by data from ACTT and SIMPLE. Updated 12 Aug 2020
23 Jul 2020 Status change - completed Status changed from active, no longer recruiting to completed. Updated 28 Jul 2020
20 Jul 2020 Other trial event This trial has been completed in France according to European Clinical Trials Database (global end of the trial 2020-06-30) Updated 20 Jul 2020
14 Jul 2020 Other trial event This trial has been completed in Spain, according to European Clinical Trials Database. Updated 14 Jul 2020
10 Jul 2020 Other trial event According to a Gilead scineces media release, an expansion phase was added to this study, which can enroll up to 5,600 additional patients, including those on mechanical ventilation. Results from the expansion phase of the study are pending. Updated 15 Jul 2020
10 Jul 2020 Results Results presented in a Gilead Sciences media release. Updated 15 Jul 2020
10 Jul 2020 Results According to an Gilead Sciences media release, data from this study and a separate subgroup analyses from this study were presented at the Virtual COVID-19 Conference as part of the 23rd International AIDS Conference (AIDS 2020: Virtual). Updated 15 Jul 2020
03 Jul 2020 Other trial event This trial has been completed in Sweden, according to European Clinical Trials Database. Updated 03 Jul 2020
08 Jun 2020 Other trial event According to a European Medicines Agency media releas, EMA has received an application for conditional marketing authorisation of the remdesivir for the treatment of COVID-19 and has started its evaluation. The assessment of the benefits and risks of remdesivir is being performed under a reduced timeline and an opinion could be issued within weeks, depending on the robustness of the data submitted and whether further information is required to support the evaluation. Updated 15 Jun 2020
29 May 2020 Completion date Planned End Date changed from 1 May 2020 to 1 Jun 2020. Updated 03 Jun 2020
29 May 2020 Other trial event Planned primary completion date changed from 1 May 2020 to 1 Jun 2020. Updated 03 Jun 2020
29 May 2020 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 03 Jun 2020
27 May 2020 Results Results (N=397), comparing efficacy of Remdesivir for 5 or 10 days in patients with severe Covid-19 infections, published in the New England Journal of Medicine Updated 01 Jun 2020
22 May 2020 Other trial event According to an Gilead Sciences media release, results from our Phase 3 SIMPLE-Severe study, which is evaluating remdesivir in a similar population of COVID-19 patients requiring oxygen but not on mechanical ventilation, will be published in the near future. These data from the SIMPLE-Severe study support treatment of some patients for 5 days rather than 10 days, depending on clinical status. Updated 29 May 2020
11 May 2020 Other trial event According to an Emalex Biosciences media release, patients who receive a 5-day treatment course but do not show clinical improvement will be eligible to continue receiving remdesivir. Updated 18 May 2020
11 May 2020 Other trial event According to an Emalex Biosciences media release, a treatment duration of 5 days has been introduced alongside the longer 10-day course, based on preliminary results from this study (GS-US-540-5773) suggesting that for patients not requiring mechanical ventilation or ECMO, the treatment course may be shortened from 10 to 5 days without any loss of efficacy. Updated 18 May 2020
11 May 2020 Other trial event According to an Emalex Biosciences media release, although remdesivir is not yet authorised for marketing in the European Union, these recommendations for compassionate use will help some patients with severe COVID-19 access the medicine while EMA evaluates data on its benefits and risks. When the evaluation is complete, EMA will make a recommendation on whether or not remdesivir should receive a marketing authorisation. Updated 18 May 2020
11 May 2020 Other trial event According to an Emalex Biosciences media release, in addition to patients undergoing invasive mechanical ventilation, the compassionate use recommendations now cover the treatment of hospitalised patients requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or ECMO (extracorporeal membrane oxygenation). Updated 18 May 2020
11 May 2020 Other trial event According to an Emalex Biosciences media release, the updated recommendations are based on preliminary results from the NIAID-ACTT study, which suggest a beneficial effect of remdesivir in the treatment of hospitalised patients with severe COVID-19.EMA is currently evaluating these data in the context of the rolling review of remdesivir. Updated 18 May 2020
11 May 2020 Other trial event According to an Emalex Biosciences media release, EMAs human medicines committee (CHMP) has recommended expanding the compassionate use of the investigational medicine remdesivir so that more patients with severe COVID-19 can be treated. Updated 18 May 2020
07 May 2020 Other trial event According to an Gilead Sciences media release, the Japanese Ministry of Health, Labour and Welfare (MHLW) approval is based on clinical data from the U.S. National Institute of Allergy and Infectious Diseases's global Phase 3 trial, the company's Phase 3 SIMPLE trial in patients with severe manifestations of COVID-19, and available data from company's compassionate use program, including patients in Japan. Updated 12 May 2020
07 May 2020 Other trial event According to an Gilead Sciences media release, the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval of Veklury (remdesivir) as a treatment for SARS-CoV-2 infection under an exceptional approval pathway. The exceptional approval was granted due to the COVID-19 pandemic and references the Emergency Use Authorization of remdesivir in the United States. Updated 12 May 2020
01 May 2020 Other trial event According to a Gilead Sciences media release, the EUA is temporary and does not take the place of the formal new drug application submission, review and approval process. The EUA allows for the distribution and emergency use of remdesivir only for the treatment of COVID-19, remdesivir remains an investigational drug and has not been approved by FDA. Updated 08 May 2020
01 May 2020 Other trial event According to a Gilead Sciences media release, the EUA is based on available data from two global clinical trials, the National Institute for Allergy and Infectious Diseases placebo-controlled Phase 3 study in patients with moderate to severe symptoms of COVID-19 (NCT04280705), including those who were critically ill, and Gileads global Phase 3 study evaluating 5-day and 10-day dosing durations of remdesivir in patients with severe disease (NCT04292899). Updated 08 May 2020
01 May 2020 Other trial event According to a Gilead Sciences media release, the U.S. FDA has granted emergency use authorization (EUA) for the investigational antiviral remdesivir to treat COVID-19. The EUA will facilitate broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease, enabling access to remdesivir at additional hospitals across the country. Under the EUA, both 5-day and 10-day treatment durations are suggested, based on the severity of disease. Updated 08 May 2020
29 Apr 2020 Other trial event According to an Gilead Sciences media release, Gilead will share additional remdesivir data from this trial with severe COVID-19 disease shortly. This study will provide information on whether a shorter, 5-day duration of therapy may have similar efficacy and safety as the 10-day treatment course evaluated in the NIAID trial and other ongoing trials. Updated 04 May 2020
29 Apr 2020 Results Results published in Gilead Sciences Media Release Updated 04 May 2020
16 Apr 2020 Other trial event Planned number of patients changed from 2400 to 6000. Updated 20 Apr 2020
10 Apr 2020 Other trial event According to an Gilead Sciences media release, data from this study is expected in April 2020(this month). Updated 16 Apr 2020
30 Mar 2020 Other trial event Planned number of patients changed from 400 to 2400. Updated 30 Mar 2020
20 Mar 2020 Other trial event According to a University Hospitals media release, this trial is approved by the U.S. Food and Drug Administration (FDA) and UH Institutional Review Board and are expecting shipment of the experimental drug remdesivir in the next couple of days. Updated 26 Mar 2020
20 Mar 2020 Other trial event According to a University Hospitals media release, the UH is hoping to open the trial at UH Ahuja, Parma and St. John medical centers. Updated 26 Mar 2020
20 Mar 2020 Other trial event According to a University Hospitals media release, this study will be conducted by the UH Clinical Research Center, under the leadership of Grace McComsey, MD, Vice President of Research and Associate Chief Scientific Officer at UH. Updated 26 Mar 2020
20 Mar 2020 Other trial event According to the Feinstein Institute for Medical Research media release, the lead investigator on this study is Marcia Epstein, MD, Feinstein Institutes researcher and an infectious disease expert. Updated 23 Mar 2020
15 Mar 2020 Protocol amendment The lower age limit for eligibility was reduced from 18 years to 12 years, and a requirement for an axillary temperature of at least 36.6 degree Celsius at screening was eliminated. In addition, one of the primary efficacy assessments the proportions of patients with normalization of temperature at day 14 was changed to assessment of clinical status on a 7 point ordinal scale on day 14. Also amended to add an extension phase involving an additional 5600 patients Updated 01 Jun 2020
13 Mar 2020 Other trial event New source identified and integrated(European Clinical Trials Database;EudraCT2020-000841-15). Updated 13 Mar 2020
10 Mar 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 16 Mar 2020
06 Mar 2020 Other trial event New source identified and integrated (ClinicalTrials.gov record; NCT04292899) Updated 06 Mar 2020
02 Mar 2020 New trial record New trial record Updated 02 Mar 2020
28 Feb 2020 Status change - not yet recruiting Status changed from planning to not yet recruiting. Updated 06 Mar 2020
26 Feb 2020 Other trial event According to a Gilead scineces media release, this trial is led by China-Japan Friendship Hospital in China. Updated 02 Mar 2020
26 Feb 2020 Other trial event According to a Gilead scineces media release, U.S. FDA Grants Investigational New Drug Authorization for this study. This study is anticipated to begin in March. Updated 02 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Gilead Sciences. U.S. Food and Drug Administration Approves Gileads Antiviral Veklury(Rm) (remdesivir) for Treatment of COVID-19. Media-Rel 2020;.

    Media Release
  3. Diaz G, Arribas JR, Robinson PA, Cattelan AM, Tashima KT, Tsang OT-Y, et al. Geographical Disparities in Clinical Outcomes of Severe COVID-19 Patients Treated with Remdesivir. IDW-2020 2020; abstr. N/A.

    Available from: URL: https://www.eventscribe.net/2020/IDWeek/fsPopup.asp?Mode=presInfo&PresentationID=775582
  4. Gilead Sciences. Gilead Presents Additional Data on Investigational Antiviral Remdesivir for the Treatment of COVID-19. Media-Rel 2020;.

    Media Release
  5. Gilead Sciences. Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19. Media-Rel 2020;.

    Media Release
  6. Gilead Sciences. Gileads Investigational Antiviral Remdesivir Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of COVID-19. Media-Rel 2020;.

    Media Release
  7. European Clinical Trials Database. Trial-Reg 2016;.

    Available from: URL: https://www.clinicaltrialsregister.eu
  8. The Feinstein Institute for Medical Research. Feinstein Institutes begins enrolling patients in multiple COVID-19 clinical trials. Media-Rel 2020;.

    Media Release
  9. Goldman JD, Lye DCB, Hui DS, Marks KM, Bruno R, Montejano R, et al. Remdesivir for 5 or 10 Days in Patients with Severe Covid-19. . N-Engl-J-Med 2020;.

    PubMed | CrossRef Fulltext
  10. Gilead Sciences. Gilead Submits New Drug Application to U.S. Food and Drug Administration for Veklury(Rm) (Remdesivir) for the Treatment of COVID-19. Media-Rel 2020;.

    Media Release
  11. Emalex Biosciences. EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation. Media-Rel 2020;.

    Media Release
  12. Olender S, Walunas TL, Martinez E, Boffito M, Perez KK, Castagna A, et al. Remdesivir Versus Standard of Care for Severe Covid-19. CROI-2021 2021; abstr. 393.

    Available from: URL: http://www.croiconference.org/
  13. Gilead Sciences. Gilead Sciences Statement on NEJM Publication of Remdesivir Data From NIAID Study. Media-Rel 2020;.

    Media Release
  14. Gilead Sciences. Gilead Announces Approval of Veklury(Rm) (remdesivir) in Japan for Patients With Severe COVID-19. Media-Rel 2020;.

    Media Release
  15. European Medicines Agency. EMA receives application for conditional authorisation of first COVID-19 treatment in the EU. Media-Rel 2020;.

    Media Release
  16. University Hospitals. University Hospitals among first in nation to test investigational antiviral drug against COVID-19. Media-Rel 2020;.

    Media Release
  17. Gilead Sciences. Gilead Sciences Initiates Two Phase 3 Studies of Investigational Antiviral Remdesivir for the Treatment of COVID-19. Media-Rel 2020;.

    Media Release
  18. Gilead Sciences. Data on 53 Patients Treated With Investigational Antiviral Remdesivir Through the Compassionate Use Program Published in New England Journal of Medicine. Media-Rel 2020;.

    Media Release
  19. Gilead Sciences. Gilead Sciences Statement on Positive Data Emerging From National Institute of Allergy and Infectious Diseases Study of Investigational Antiviral Remdesivir for COVID-19. Media-Rel 2020;.

    Media Release
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