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: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-000842-32-FR
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
1) Willing and able to provide written informed consent prior to performing study procedures
2) Aged = 18 years
3) SARS-CoV-2 infection confirmed by PCR = 4 days before randomization
4) Currently hospitalized with fever defined as temperature = 36.6 °C armpit, = 37.2 °C oral, = 37.8 °C rectal
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? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400
1) Participation in any other clinical trial of an experimental agent treatment for COVID-19
2) 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
3) Requiring mechanical ventilation at screening
4) ALT or AST > 5 x ULN
5) Creatinine clearance < 50 mL/min
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 standard of care (SOC), with respect to the time to discharge;Secondary Objective: To evaluate the safety and tolerability of RDV compared to SOC;Primary end point(s): The proportion of participants discharged by Day 14;Timepoint(s) of evaluation of this end point: From initiation of study medication until Day 14
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The proportion of participants with treatment emergent adverse events leading to study drug discontinuation;Timepoint(s) of evaluation of this end point: From initiation of study medication until Day 14