Study to assess the safety and effectiveness of remdesivir in people with severe COVID-19

Phase 3

Completed

• Conditions: COVID-19 (SARS-CoV-2 infection); Infections and Infestations

• Registration Number: ISRCTN15874265
• Lead Sponsor: Gilead Sciences (United States)

Brief Summary

2020 results in https:doi.org/10.1056/NEJMoa2015301 (added 29/10/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-06-30
• Study Start: 2020-11-03
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 4891

Inclusion Criteria

1. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under ICH E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (participants = 18 years of age), or willing and able to provide assent (participants =12 and <18 years of age, where locally and nationally approved) prior to performing study procedures. For participants =12 and <18 years of age, a parent or legal guardian willing and able to provide written informed consent prior to performing study procedures
2. 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])
3. SARS-CoV-2 infection confirmed by PCR test =4 days before randomization
4. Currently hospitalized
5. SpO2 =94% on room air or requiring supplemental oxygen at screening
6. Radiographic evidence of pulmonary infiltrates
7. Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Exclusion Criteria

1. Participation in any other clinical trial of an experimental treatment for COVID-19
2. Concurrent treatment with other agents with actual or possible direct-acting antiviral activity against SARS-CoV-2 <24 hours prior to study drug dosing
3. Evidence of multiorgan failure
4. Mechanically ventilated (including V-V ECMO) =5 days, or any duration of V-A ECMO
5. ALT or AST >5 ULN
6. Creatinine clearance <50 mL/min using the Cockcroft-Gault formula for participants =18 years of age and Schwartz Formula for participants <18 years of age
7. Positive pregnancy test
8. Breastfeeding woman
9. Known hypersensitivity to the study drug, the metabolites, or formulation excipient

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The odds of ratio for improvement on a 7-point ordinal scale on day 14, calculated from daily scores taken each day from baseline to day 14. (The ordinal scale is an assessment of the clinical status at a given 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 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

Name	Time	Method
Adverse Events recorded from patient medical records from the time of consent up to Day 28 (+/-5 days). Serious adverse events were reported up to 30 days of last dose and after the protocol defined follow-up period if deemed relevant to the use of study drug.