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.

Phase 1

• Conditions: Coronavirus disease 2019 (COVID-19); MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-000842-32-ES
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-11
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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

Exclusion Criteria

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