A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734*) in Participants with Moderate COVID-19 Compared to Standard of Care Treatment
- Conditions
- COVID-19Corona10047438
- Registration Number
- NL-OMON49717
- Lead Sponsor
- Gilead Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Subjects must meet all of the following inclusion criteria to be eligible for
participation in this study:
1) Willing and able to provide written informed consent (participants >= 18
years of age) or 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 IRB/IEC)
3) SARS-CoV-2 infection confirmed by PCR <= 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 as
described in Protocol Appendix 3.
Subjects who meet anyof the following exclusion criteria are not to be enrolled
in this study:
1) Participation in any other clinical trial of an experimental agent 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 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 {Cockcroft 1976} and Schwartz Formula for
participants < 18 years of age
6) Positive pregnancy test (Protocol Appendix 3)
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 <p>The primary endpoint of this study is:<br /><br>-Clinical status assessed by a 7-point ordinal scale on Day 11</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoint of this study is:<br /><br>-The proportion of participants with treatment emergent adverse events</p><br>