Study to assess the safety and effectiveness of remdesivir in people with moderate COVID-19
- Conditions
- COVID-19 (SARS-CoV-2 infection)Infections and Infestations
- Registration Number
- ISRCTN85762140
- Lead Sponsor
- Gilead Sciences (United States)
- Brief Summary
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32821939/ (added 25/03/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1113
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 and requiring medical care for COVID-19
5. SpO2 >94% on room air 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
1. Participation in any other clinical trial of an experimental treatment for COVID-19
2. Concurrent treatment or planned concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2
3. Requiring mechanical ventilation at screening
4. ALT or AST >5 x ULN
Note: if per local practice only ALT is routinely measured, exclusion criteria will be evaluated on ALT alone
5. 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
6. Positive pregnancy test
7. Breastfeeding woman
8. 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 <br> The Odds of Ratio for Improvement on a 7-point Ordinal Scale<br> (The ordinal scale is an assessment of the clinical status on 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.)<br> The ordinal scale was recorded each day from Baseline until discharge or Day14, any change in category from Day 14 to discharge (or Day28) was also recorded.<br>
- Secondary Outcome Measures
Name Time Method Adverse Events were 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