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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
Overall Recruitment Status: Active, enrollment completed
 
Official Title
A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate COVID-19 Compared to Standard of Care Treatment
 
Region Sponsors
Hawaii
Gilead Sciences
 
Acronym KP IRB No.
SSU00118916
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals 12 Years and Older with confirmed COVID 19 Infection
 
Purpose
The primary objective of this study is 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.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
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
 
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

 
Keywords and/or Specific Medical Conditions
  • Infectious Diseases
 
KP Clinical Facility
  • Moanalua Medical Center and Clinic
 
Clinical Area
  • Infectious Diseases


Principal Investigator:
Sophia Tran, MD
Contact Information:
- Kesha Morgan, PharmD
-808-432-8235
-Kesha.t.morgan@kp.org
-Moanalua Medical Center and Clinic


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