A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734) in Participants With Severe COVID-19
Latest Information Update: 22 Jun 2022
At a glance
- Drugs Remdesivir (Primary)
- Indications COVID 2019 infections
- Focus Registrational; Therapeutic Use
- Acronyms SIMPLE; SIMPLE-severe
- Sponsors Gilead Sciences
- 24 Jun 2021 Results of an analysis assessing all cause mortality hazard ratios, overall and stratified by baseline oxygen ; data were used from this trial and compared with a study GS-US-540-5807 (EUPAS34303; a real-world retrospective longitudinal cohort study) presented at the World Microbe Forum 2021
- 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
Most Recent Events
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
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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 |
| JapicCTI205257 | Japan Pharmaceutical Information Center - Clinical Trials Information |
Organisations
- Sponsors Gilead Sciences
- Affiliations Gilead Sciences
Trial Dates
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Initiation Dates
Planned : 01 Mar 2020
Actual : 06 Mar 2020
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Primary Completion Dates
Planned : 01 Jun 2020
Actual : 09 Apr 2020
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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; Europe; France; Germany; Hong Kong; Italy; Japan; Netherlands; North America; 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
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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 -
Gilead Sciences. Gilead Presents Additional Data on Investigational Antiviral Remdesivir for the Treatment of COVID-19. Media-Rel 2020;.
Media Release -
Gilead Sciences. Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19. Media-Rel 2020;.
Media Release -
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 -
Go AS, Malenica I, Fusco D, Gunthard HF, Ahn M, Gupta SK, et al. Remdesivir Vs. Standard Of Care For Severe Covid-19. ASM-FEMS-WMF-2021 2021; abstr. N/A.
Available from: URL: https://www.abstractsonline.com/pp8/9286/presentation/10402 -
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/
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 |
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Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
show details
GileadClinicalTrials@gilead.com |
Gilead Sciences | USA |
| Gilead Study Director | Gilead Sciences | USA |
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Ms Devi Sengupta
333 Lakeside Drive Foster City California 94404 United States of America +1 646-351-9642 Devi.SenGupta@gilead.com
show details
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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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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 |
|---|---|---|
| 22 Jun 2022 | Other trial event | Last checked against European Clinical Trials Database record. Updated 22 Jun 2022 |
| 16 Dec 2021 | Other trial event | New source identified and integrated(Japan Pharmaceutical Information Center - Clinical Trials Information:JapicCTI205257 ). Updated 16 Dec 2021 |
| 24 Jun 2021 | Results | Results of an analysis assessing all cause mortality hazard ratios, overall and stratified by baseline oxygen ; data were used from this trial and compared with a study GS-US-540-5807 (EUPAS34303; a real-world retrospective longitudinal cohort study) presented at the World Microbe Forum 2021 Updated 02 Aug 2021 |
| 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 |
| 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 |
Table of Contents
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