Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults

Next Previous
Trial Profile

A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 26 May 2020

Print Profile Download Citation

At a glance

  • Drugs Baricitinib (Primary) ; Remdesivir (Primary)
  • Indications COVID 2019 infections; Severe acute respiratory syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms ACTT; ACTT II; NIAID-ACTT

    • Most Recent Events

    • 26 May 2020 According to an Emmes media release, the company continues to support the adaptive-design of this study its second stage, in which subjects will be treated with remdesivir and randomized to receive the anti-inflammatory drug baricitinib.
    • 22 May 2020 Interim Results published in the New England Journal of Medicine
    • 18 May 2020 According to an Enzychem Lifesciences media release, Dr. Cameron Wolfe is an investigator for this study.

Trial Overview

Purpose

This phase III, placebo-controlled trial is designed to evaluate the safety and efficacy of novel therapeutic agents (Remdesivir) in hospitalized adults diagnosed with COVID-19.
The study is comparing different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm.

Comments

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 another 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 an Gilead Sciences media release, data from this study will be reviewed by CHMP as a part of rolling review (as of 4th May 2020).
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

Time to recovery

description: Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
time_frame: Day 1 through Day 29

Other Endpoints

Change from baseline in alanine transaminase (ALT)

time_frame: Day 1 through Day 29

Change from baseline in aspartate transaminase (AST)

time_frame: Day 1 through Day 29

Change from baseline in creatinine

time_frame: Day 1 through Day 29

Change from baseline in glucose

time_frame: Day 1 through Day 29

Change from baseline in hemoglobin

time_frame: Day 1 through Day 29

Change from baseline in platelets

time_frame: Day 1 through Day 29

Change from baseline in prothrombin time (PT)

time_frame: Day 1 through Day 29

Change from baseline in total bilirubin

time_frame: Day 1 through Day 29

Change from baseline in white blood cell count (WBC) with differential

time_frame: Day 1 through Day 29

Change in National Early Warning Score (NEWS) from baseline

description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
time_frame: Day 1 through Day 29

Clinical status using ordinal scale

description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring 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 requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
time_frame: Day 3 through Day 29

Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs)

description: Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating.
Grade 4 AEs are defined as events that are potentially life threatening.
time_frame: Day 1 through Day 29

Cumulative incidence of serious adverse events (SAEs)

description: An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
time_frame: Day 1 through Day 29

Discontinuation or temporary suspension of investigational therapeutics

description: For any reason.
time_frame: Day 1 through Day 10

Duration of hospitalization

description: Measured in days.
time_frame: Day 1 through Day 29

Duration of new non-invasive ventilation or high flow oxygen use

description: Measured in days.
time_frame: Day 1 through Day 29

Duration of new oxygen use

description: Measured in days.
time_frame: Day 1 through Day 29

Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use

description: Measured in days.
time_frame: Day 1 through Day 29

Incidence of new non-invasive ventilation or high flow oxygen use

time_frame: Day 1 through Day 29

Incidence of new oxygen use

time_frame: Day 1 through Day 29

Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use

time_frame: Day 1 through Day 29

Mean change in the ordinal scale

description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring 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 requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
time_frame: Day 1 through Day 29

Percentage of subjects reporting each severity rating on an 8-point ordinal scale

description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring 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 requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
time_frame: Day 15

Subject 14-day mortality

description: Date and cause of death (if applicable).
time_frame: Day 1 through Day 15

Subject 29-day mortality

description: Date and cause of death (if applicable).
time_frame: Day 1 through Day 29

Time to an improvement of one category using an ordinal scale

description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring 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 requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
time_frame: Day 1 through Day 29

Time to an improvement of two categories using an ordinal scale

description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring 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 requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
time_frame: Day 1 through Day 29

Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first

description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
time_frame: Day 1 through Day 29 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Severe acute respiratory syndrome treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 800

    Actual: 1063

  • Sex male & female
  • Age Group 18-99 years (mean age -58.9 years); adult; elderly

Patient Inclusion Criteria

1. Admitted to a hospital with symptoms suggestive of COVID-19 infection. 2. Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. 3. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures. 4. Male or non-pregnant female adult > / = 18 years of age at time of enrollment. 5. Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen, as documented by either or the following: - PCR positive in sample collected < 72 hours prior to randomization; OR - PCR positive in sample collected >/= 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection. 6. Illness of any duration, and at least one of the following: - Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR - SpO2 < / = 94% on room air, OR - Requiring supplemental oxygen, OR - Requiring mechanical ventilation. 7. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29. 8. Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 through Day 29.

Patient Exclusion Criteria

1. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit of normal. 2. Estimated glomerular filtration rate (eGFR) < 30 ml/min (including patients receiving hemodialysis or hemofiltration). 3. Pregnancy or breast feeding. 4. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. 5. Allergy to any study medication.

Trial Details

Identifiers

Identifier Owner
NCT04280705 ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-001052-18 European Clinical Trials Database
U1111-1249-9599 World Health Organisation
20-0006 -
INSIGHTPROTOCOL010 -

Organisations

  • Affiliations Gilead Sciences

Trial Dates

  • Initiation Dates

    Planned : 12 Mar 2020

    Actual : 21 Feb 2020

  • Primary Completion Dates

    Planned : 01 Apr 2023

  • End Dates

    Planned : 01 Apr 2023

Other Details

  • Design double-blind; multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase III
  • Location Denmark; England; Germany; Greece; Japan; Mexico; Singapore; South Korea; Spain; United Kingdom; USA
  • Focus Registrational; Therapeutic Use

Interventions

Drugs Route Formulation
BaricitinibPrimary Drug Oral Tablet
RemdesivirPrimary Drug Intravenous Infusion, Injection, Lyophilised

Placebo

200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. n=286. Other: Placebo (The supplied placebo lyophilized formulation is identical in physical appearance to the active lyophilized formulation and contains the same inactive ingredients. Alternatively, a placebo of normal saline of equal volume may be given if there are limitations on matching placebo supplies.)

Remdesivir

200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course. n=286. Drug: Remdesivir (Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.)

Results

Publications

  1. Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, et al. Remdesivir for the Treatment of Covid-19 - Preliminary Report. . N-Engl-J-Med 2020;.

    PubMed | CrossRef Fulltext

  2. EvergreenHealth. EvergreenHealth Prepares for Second Arm of Clinical Trial After Initial Findings Show Promising Results for Remdesivir as Potential Treatment for COVID-19. Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
Atmar RL 1 - -
Babiker AG 1 - -
Beigel JH 1 1 -
Benfield T 1 - -
Bonnett T 1 - -
Burgess TH 1 - -
Chu HY 1 - -
Creech CB 1 - -
Dierberg K 1 - -
Dodd LE 1 - -
EvergreenHealth 1 1 1
Fatkenheuer G 1 - -
Finberg RW 1 - -
Green M 1 - -
Hohmann E 1 - -
Hsieh L 1 - -
Kalil AC 1 - -
Kline S 1 - -
Kortepeter MG 1 - -
Lane HC 1 - 1
Lopez de Castilla D 1 - -
Luetkemeyer A 1 - -
Lundgren J 1 - -
Lye DC 1 - -
Makowski M 1 - -
Mehta AK 1 - -
Nayak S 1 - -
Neaton JD 1 - -
Oh MD 1 - -
Ohmagari N 1 - -
Osinusi A 1 - -
Paredes R 1 - -
Patterson TF 1 - -
Pett S 1 - -
Ruiz-Palacios GM 1 - -
Short WR 1 - -
Sweeney DA 1 - -
Tapson V 1 - -
Tomashek KM 1 - -
Touloumi G 1 - -
Zingman BS 1 - -

Trial Centres

Investigators

Download Data (CSV)
Investigator Centre Name Trial Centre Country
20-0006 Central Contact
13017617948 DMIDClinicalTrials@niaid.nih.gov
show details
-

Centres

Download Data (CSV)
Centre Name Location Trial Centre Country
-
-
-
AHEPA University Hospital - 1st Department of Internal Medicine Thessaloniki, Central Macedonia Greece
Atlanta VA Medical Center - Infectious Diseases Clinic Decatur, Georgia USA
Baylor College of Medicine - Molecular Virology and Microbiology Houston, Texas USA
Brooke Army Medical Center Fort Sam Houston, Texas USA
Cedars Sinai Medical Center West Hollywood, California USA
Changi General Hospital - Clinical Trials and Research Unit (CTRU) Singapore Singapore
Denver Health Division of Hospital Medicine - Main Campus Denver, Colorado USA
Duke Human Vaccine Institute - Duke Vaccine and Trials Unit Durham, North Carolina USA
Emory Vaccine Center - The Hope Clinic Decatur, Georgia USA
EvergreenHealth Infectious Disease Service Kirkland, Washington USA
Hospital Clinic Barcelona, Servicio de Salud Internacional Barcelona, Cataluña Spain
Hospital Germans Trias i Pujol - Servei Malalties Infeccioses Barcelona, Cataluña Spain
Hospital of the University of Pennsylvania - Infectious Diseases Philadelphia, Pennsylvania USA
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán - Departamento de Infectologia Mexico City Mexico
Instituto Nacional de Enfermedades Respiratorias (INER) - Ismael Cosío Villegas Mexico City Mexico
John Radcliffe Hospital Headington, Oxford United-Kingdom
Johns Hopkins Hospital - Medicine - Infectious Diseases Baltimore, Maryland USA
Khoo Teck Puat Hospital - Clinical Research Unit Singapore Singapore
Madigan Army Medical Center - Infectious Disease Clinic Tacoma, Washington USA
Massachusetts General Hospital - Infectious Diseases Boston, Massachusetts USA
Medical School of Athens University - Evangelismos Hospital - Department of Critical Care and Pulmonary Services Athens Greece
Montefiore Medical Center - Infectious Diseases Bronx, New York USA
National Center for Global Health and Medicine Hospital - Disease Control and Prevention Center Tokyo Japan
National Centre for Infectious Diseases (NCID) Singapore Singapore
National Institute of Allergy and Infectious Diseases (NIAID)
-
-
National Institutes of Health - Clinical Center, National Institute of Allergy and Infectious Diseases Laboratory Of Immunoregulation, Clinical Research Section Bethesda, Maryland USA
National University Health System - Division of Infectious Diseases Singapore Singapore
Naval Medical Center Portsmouth - Infectious Disease Division Portsmouth, Virginia USA
Naval Medical Center San Diego - Infectious Disease Clinic San Diego, California USA
New York University School of Medicine - Langone Medical Center - Microbiology - Parasitology New York, New York USA
Ng Teng Fong General Hospital - Infectious Disease Service Singapore Singapore
Northwestern Hospital - Infectious Disease Chicago, Illinois USA
Penn State Health Milton S. Hershey Medical Center - Division of Infectious Diseases Hershey, Pennsylvania USA
Providence Sacred Heart Medical Center Spokane, Washington USA
Rocky Mountain Regional Veteran Affairs Medical Center - Department of Infectious Diseases Aurora, Colorado USA
Royal Sussex County Hospital - Department of Intensive Care Medicine East Sussex, Brighton United-Kingdom
Royal Victoria Infirmary - Department of Infectious Diseases Level 6, Ward 19, Newcastle Upon Tyne United-Kingdom
Saint Louis University - Center for Vaccine Development Saint Louis, Missouri USA
Saint Thomas' Hospital - Directorate of Infection London, London, City Of United-Kingdom
Seoul National University Bundang Hospital - Division of Infectious Diseases Bundang-gu Seongnam-si, Gyeonggi-do South-Korea
Seoul National University Hospital Seoul, Jongno-gu South-Korea
Singapore General Hospital - Department of Infectious Diseases Singapore Singapore
Southeast Louisiana Veterans Health Care System (SLVHCS) - Section of Infectious Diseases New Orleans, Louisiana USA
St. James's University Hospital - Infectious Diseases Leeds, West Yorkshire United-Kingdom
Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases Palo Alto, California USA
The University of Washington - Virology Research Clinic Seattle, Washington USA
Universitatsklinikum Bonn, Medizinische Klinik I - Bereich Infektiologie/HIV der Medizinischen Klinik Bonn, Nordrhein-Westfalen Germany
Universitatsklinikum Koeln Klinik I fur Innere Medizin Klinisches Studienzentrum fur Infektiologie I Cologne Germany
University of Alabama at Birmingham School of Medicine - Infectious Disease Birmingham, Alabama USA
University of California Davis Medical Center - Internal Medicine - Infectious Disease Sacramento, California USA
University of California Irvine Medical Center - Infectious Disease Orange, California USA
University of California Los Angeles Medical Center - Westwood Clinic Los Angeles, California USA
University of California San Diego Health - Jacobs Medical Center La Jolla, California USA
University of California San Francisco - Zuckerberg San Francisco General Hospital - Division of Human Immunodeficiency Virus, Infectious Disease, and Global Medicine San Francisco, California USA
University of Copenhagen - Centre of Excellence for Health, Immunity and Infections (CHIP) - Department of Infectious Diseases Copenhagen Denmark
University of Florida Health - Shands Hospital - Division of Infectious Diseases and Global Medicine Gainesville, Florida USA
University of Illinois at Chicago College of Medicine - Division of Infectious Diseases Chicago, Illinois USA
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore Annapolis, Maryland USA
University of Massachusetts Medical School - Infectious Diseases and Immunology Worcester, Massachusetts USA
University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine Minneapolis, Minnesota USA
University of Nebraska Medical Center - Infectious Diseases Omaha, Nebraska USA
University of Pennsylvania Perelman School of Medicine - Penn Institute for Immunology Philadelphia, Pennsylvania USA
University of Rochester Medical Center - Vaccine Research Unit Rochester, New York USA
University of Texas Health Science Center at San Antonio - Infectious Diseases San Antonio, Texas USA
University of Texas Medical Branch - Division of Infectious Disease Galveston, Texas USA
University of Virginia - Acute Care Surgery Charlottesville, Virginia USA
Universitätsklinikum Frankfurt -Medizinische Klinik II - Infektiologie Frankfurt Germany
VA Palo Alto Health Care System - Infectious Diseases Palo Alto, California USA
Vanderbilt University Medical Center - Infectious Diseases Nashville, Tennessee USA
Walter Reed National Military Medical Center Bethesda, Maryland USA

+ Lead Centre

Show all rows

Trial History

Event Date Event Type Comment
26 May 2020 Other trial event According to an Emmes media release, the company continues to support the adaptive-design of this study its second stage, in which subjects will be treated with remdesivir and randomized to receive the anti-inflammatory drug baricitinib. Updated 28 May 2020
22 May 2020 Interim results Interim Results published in the New England Journal of Medicine Updated 26 May 2020
18 May 2020 Other trial event According to an Enzychem Lifesciences media release, Dr. Cameron Wolfe is an investigator for this study. Updated 22 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 another 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, 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, 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, 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
08 May 2020 Other trial event Last checked against Eudra record. Updated 08 May 2020
08 May 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 08 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
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
04 May 2020 Other trial event According to an Gilead Sciences media release, data from this study will be reviewed by CHMP as a part of rolling review. Updated 06 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 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 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
30 Apr 2020 Other trial event According to an EvergreenHealth media release, Dr. Diego Lopez de Castilla, EvergreenHealth infectious disease specialist is a lead investigator of the study. Updated 05 May 2020
30 Apr 2020 Results Results (n=1063) presented in an EvergreenHealth media release. Updated 05 May 2020
30 Apr 2020 Other trial event According to an EvergreenHealth media release, the institute is preparing to move forward the study by entering into the second arm of the study. The second phase of the trial, ACTT II, will eliminate the placebo group, and instead provide all study participants with Remdesivir. All the patients from the EvergreenHealth's care will receive an open-label Remdesivir. The ACTT II is expected to run for three years. Updated 05 May 2020
29 Apr 2020 Other trial event According to an Gilead Sciences media release, NIAID will provide detailed information at an upcoming briefing Updated 07 May 2020
29 Apr 2020 Endpoint met Primary endpoint has been met. (Time to recovery) Updated 07 May 2020
23 Apr 2020 Other trial event Planned number of patients changed from 572 to 800. Updated 29 Apr 2020
16 Apr 2020 Protocol amendment Primary endpoint has been changed from "Percentage of subjects reporting each severity rating on an 8-point ordinal scale" to Time to recovery. Updated 21 Apr 2020
16 Apr 2020 Other trial event Planned number of patients changed from 440 to 572. Updated 21 Apr 2020
10 Apr 2020 Other trial event According to an Gilead Sciences media release, this study continues to enroll patients and data are anticipated in May 2020. Updated 16 Apr 2020
30 Mar 2020 Other trial event New source identified and integrated:European Clinical Trials Database;EudraCT2020-001052-18. Updated 30 Mar 2020
24 Mar 2020 Other trial event According to an UC San Dieg media release,The trial is projected to run to April 1, 2023 and will ultimately involve an estimated total of 440 participants. It is sponsored by the National Institute of Allergy and Infectious Disease, part of the National Institutes of Health (NIH). Updated 07 May 2020
24 Mar 2020 Other trial event According to an UC San Dieg media release, Constance Benson, M.D., professor of medicine at UC San Diego School of Medicine and an infectious disease specialist at UC San Diego Health.o health media release is co-principal investigator of this study and this study sponsored by the National Institute of Allergy and Infectious Disease, part of the National Institutes of Health (NIH). Updated 07 May 2020
21 Mar 2020 Other trial event According to a U.S. Department of Health and Human Services media release, the US Department of Health and Human Services id funding this trial. Updated 26 Mar 2020
20 Mar 2020 Protocol amendment Phase has been changed from phase II to phase III. Updated 26 Mar 2020
20 Mar 2020 Other trial event Planned number of patients changed from 394 to 440. Updated 26 Mar 2020
25 Feb 2020 Other trial event According to a National Institute of Allergy and Infectious Diseases media release, the first participant is an American who was repatriated after being quarantined on the Diamond Princess cruise ship that docked in Yokohama, Japan and volunteered to participate in the study. Updated 27 Feb 2020
25 Feb 2020 Status change - recruiting Status changed from not yet recruiting to recruiting, according to a National Institute of Allergy and Infectious Diseases media release. Updated 27 Feb 2020
24 Feb 2020 New trial record New trial record Updated 24 Feb 2020

References

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

    Available from: URL: http://clinicaltrials.gov

  2. US Department of Health and Human Services. HHS Funds Phase 2/3 Clinical Trial for Potential Treatment for COVID-19. Media-Rel 2020;.

    Media Release

  3. 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

  4. UC San Diego Health Launches Clinical Trial to Assess Antiviral Drug for COVID-19. Media-Rel 2020;.

    Media Release

  5. European Clinical Trials Database. Trial-Reg 2016;.

    Available from: URL: https://www.clinicaltrialsregister.eu

  6. Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, et al. Remdesivir for the Treatment of Covid-19 - Preliminary Report. . N-Engl-J-Med 2020;.

    PubMed | CrossRef Fulltext

  7. European Medicines Agency. EMA starts rolling review of remdesivir for COVID-19. Media-Rel 2020;.

    Media Release

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

    Media Release

  9. National Institute of Allergy and Infectious Diseases. NIH Clinical Trial of Remdesivir to Treat COVID-19 Begins. Media-Rel 2020;.

    Media Release

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

    Media Release

  11. EvergreenHealth. EvergreenHealth Prepares for Second Arm of Clinical Trial After Initial Findings Show Promising Results for Remdesivir as Potential Treatment for COVID-19. Media-Rel 2020;.

    Media Release

  12. Enzychem Lifesciences Corporation. Enzychem Lifesciences Appoints Duke Medical Coronavirus Task Force Expert Dr. Cameron Wolfe to Lead Development of EC-18 as a COVID-19 Therapeutic Drug. Media-Rel 2020;.

    Media Release

  13. 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

  14. Emmes Announces its Contribution to NIH ACTT Clinical Trial for Remdesivir. Media-Rel 2020;.

    Media Release

  15. 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
Adis International Ltd. Part of Springer Science+Business Media
© Springer Nature Switzerland AG

Legal

Back to top