Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)

Phase 3

Completed

• Conditions: COVID-19
• Interventions: Drug: Remdesivir; Drug: Standard of Care

• Registration Number: NCT04292899
• Lead Sponsor: Gilead Sciences

Brief Summary

The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-28
• Study First Submitted QC: 2020-02-28
• Study First Posted: 2020-03-03
• Study Start: 2020-03-06
• Primary Completion: 2020-04-09
• Study Completion: 2020-06-30
• Status Verified: 2020-12
• Results First Submitted: 2020-12-15
• Results First Submitted QC: 2020-12-15
• Last Update Submitted: 2020-12-15
• Results First Posted: 2020-12-31
• Last Update Posted: 2020-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4891

Inclusion Criteria

• Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥ 18), or willing and able to provide assent (age ≥ 12 to < 18, where locally and nationally approved) prior to performing study procedures
• 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 institutional review board (IRB) or independent ethics committee (IEC))
• Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization
• Currently hospitalized
• Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen at screening

Key

Exclusion Criteria

• Participation in any other clinical trial of an experimental treatment for COVID-19
• 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
• Evidence of multiorgan failure
• Mechanically ventilated [including veno-venous (V-V) extracorporeal membrane oxygenation (ECMO)] ≥ 5 days, or any duration of veno-arterial (V-A) ECMO.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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 B: Remdesivir 10 days (Mechanically Ventilated)	Standard of Care	Participants on mechanical ventilation will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10
Part A: Remdesivir (RDV), 5 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, and 5.
Part B: Remdesivir, 10 Days (Extension)	Standard of Care	Part B (Extension) will enroll participants after enrollment to Part A is complete. Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10.
Part A: Remdesivir (RDV), 5 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, 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: Remdesivir, 10 Days (Extension)	Remdesivir	Part B (Extension) will enroll participants after enrollment to Part A is complete. Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10.
Part B: Remdesivir 10 days (Mechanically Ventilated)	Remdesivir	Participants on mechanical ventilation will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10

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 14	Day 14	Clinical status was derived from death, hospital discharge, and the 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 assessment carried forward for any missing values.The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or 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 (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 the Remdesivir for 10 days group vs the Remdesivir for 5 days 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	Treatment-emergent Adverse Events (TEAE) were defined as AEs with onset dates on or after the study treatment start date and no later than 30 days after the permanent discontinuation of the study treatment and/or the AEs that led to premature discontinuation of study treatment.

Trial Locations

Locations (182)

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; 🇺🇸 Burlingame, California, United States

Eden Medical Center; 🇺🇸 Castro Valley, California, United States

Kaiser Permanente Los Angeles Medical Center, 9333 Imperial Highway; 🇺🇸 Downey, California, United States

Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave; 🇺🇸 Fontana, California, United States

St Joseph Hospital Eureka; 🇺🇸 Fortuna, California, United States

Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave.; 🇺🇸 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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