This study will test a drug named remdesivir (GS-5734™) to evaluate the safety and effectiveness of the drug in treating patients with moderate coronavirus disease 2019 (COVID-19) compared to standard of care treatment.
- Conditions
- Coronavirus disease 2019 (COVID-19)MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-000842-32-DE
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1113
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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1000
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 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of 2 remdesivir (RDV) regimens compared to<br>standard of care (SOC), with respect to clinical status assessed by a 7-<br>point ordinal scale on Day 11;Secondary Objective: To evaluate the safety and tolerability of RDV compared to SOC;Primary end point(s): Clinical status assessed by a 7-point ordinal scale on Day 11;Timepoint(s) of evaluation of this end point: Day 11
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The proportion of participants with treatment emergent adverse events;Timepoint(s) of evaluation of this end point: From initiation of study medication until Day 14