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Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04292899
Recruitment Status : Completed
First Posted : March 3, 2020
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Remdesivir Drug: Standard of Care Phase 3

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4891 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe COVID-19
Actual Study Start Date : March 6, 2020
Actual Primary Completion Date : April 9, 2020
Actual Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: Part A: Remdesivir (RDV), 5 Days (Not Mechanically Ventilated)
Participants who are not mechanically ventilated 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 Names:
  • GS-5734™
  • Veklury®

Drug: Standard of Care
Standard of Care Treatment for COVID-19 Infection

Experimental: Part A: Remdesivir, 10 Days (Not Mechanically Ventilated)
Participants who are not mechanically ventilated 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 Names:
  • GS-5734™
  • Veklury®

Drug: Standard of Care
Standard of Care Treatment for COVID-19 Infection

Experimental: Part B: Remdesivir, 5 or 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 Names:
  • GS-5734™
  • Veklury®

Drug: Standard of Care
Standard of Care Treatment for COVID-19 Infection

Experimental: 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 Names:
  • GS-5734™
  • Veklury®

Drug: Standard of Care
Standard of Care Treatment for COVID-19 Infection




Primary Outcome Measures :
  1. The Odds of Ratio for Improvement on a 7-point Ordinal Scale on Day 14 [ Time Frame: Day 14 ]
    The odds ratio represents the odds of improvement in the ordinal scale between the treatment groups. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. 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 low flow supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus (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.


Secondary Outcome Measures :
  1. Proportion of Participants Experiencing any Treatment-Emergent Adverse Events [ Time Frame: First dose date up to 10 days plus 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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 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 V-V ECMO) ≥ 5 days, or any duration of 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04292899


Locations
Show Show 183 study locations
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
Publications:
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT04292899    
Other Study ID Numbers: GS-US-540-5773
2020-000841-15 ( EudraCT Number )
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No