Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment

Phase 3

Completed

Brief Summary: The primary objective of this study was to evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale on Day 11.

Recruitment & Eligibility

Inclusion Criteria

Willing and able to provide written informed consent prior to performing study procedures (participants ≥ 18 years of age) or assent (participants ≥ 12 and < 18 years of age) 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
Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization
Currently hospitalized and requiring medical care for COVID-19
Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening
Radiographic evidence of pulmonary infiltrates

Key

Exclusion Criteria

Participation in any other clinical trial of an experimental treatment for COVID-19
Concurrent treatment or planned concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2
Requiring mechanical ventilation at screening
Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Arm && Interventions

Group	Intervention	Description
Part A: Remdesivir (RDV), 5 Days	Standard of Care	Participants will receive continued standard of care (SOC) therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, and 5.
Part A: Remdesivir, 10 Days	Standard of Care	Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.
Part A: SOC Therapy	Standard of Care	Participants will receive continued standard of care therapy.
Part B: Extension Treatment, Remdesivir 10 Days	Standard of Care	Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.
Part A: Remdesivir (RDV), 5 Days	Remdesivir	Participants will receive continued standard of care (SOC) therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, and 5.
Part A: Remdesivir, 10 Days	Remdesivir	Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.
Part B: Extension Treatment, Remdesivir 10 Days	Remdesivir	Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.

Primary Outcome Measures

Name	Time	Method
Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11	Day 11	Clinical status was derived from death, hospital discharge, and ordinal scale as follows: score of "1" was used for all days on or after the date of death; score of "7" was used for all days on or after discharged alive date; last available assessment for missing value. The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO); 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring low flow supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus (COVID-19) related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol remdesivir administration; 7. Not hospitalized. The odds ratio represents the odds of improvement in the ordinal scale for a RDV group relative to the SOC group.

Secondary Outcome Measures

Name	Time	Method
Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)	First dose date up to last dose date (maximum: 10 days) plus 30 days	TEAEs were defined as the following: any AE with an onset date on or after the study treatment start date and no later than 30 days after permanent discontinuation of study treatment and/or any AE leading to premature discontinuation of study treatment. For participants randomized to the SOC group, all AEs reported on or after the protocol-specified Day 1 visit were considered as treatment emergent.

Locations (183): Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue
🇺🇸
Anaheim, California, United States
Alta Bates Summit Medical Center
🇺🇸
Berkeley, California, United States
Mills-Peninsula Medical Center
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Burlingame, California, United States
Eden Medical Center
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Castro Valley, California, United States
Kaiser Permanente Los Angeles Medical Center, 9333 Imperial Highway
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Downey, California, United States
Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave
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Fontana, California, United States
St Joseph Hospital Eureka
🇺🇸
Fortuna, California, United States
Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave.
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Harbor City, California, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸
Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center, 6041 Cadillac Ave.
🇺🇸
Los Angeles, California, United States
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Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue
🇺🇸Anaheim, California, United States