This study will test a drug named remdesivir (GS-5734™) to evaluate the safety and effectiveness of the drug in treating patients with severe coronavirus disease 2019 (COVID-19).

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: EUCTR2020-000841-15-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: 400

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 = 36.6 °C armpit, = 37.2°C oral, = 37.8 °C rectal
5) SpO2 > 94% on room air at screening
6) Radiographc 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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

1) Participation in any other clinical trial of an experimental 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) Evidence of multiorgan failure
4) Requiring mechanical ventilation at screening
5) ALT or AST > 5 x upper limit of normal (ULN)
6) Creatinine clearance < 50 mL/min
7) Positive pregnancy test (Protocol; Appendix 3)
8) Breastfeeding woman
9) 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