Study of Obeldesivir in Nonhospitalized Participants With COVID-19
- Registration Number
- NCT05715528
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The goal of this clinical study is to test if obeldesivir (GS-5245) is safe and effective for the treatment of coronavirus disease 2019 (COVID-19) in participants who have a standard risk of developing severe illness. This study will also measure how much obeldesivir gets into the blood and how long it takes for the body to get rid of it.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2011
-
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed, ≤ 3 days before randomization, by polymerase chain reaction (PCR), rapid antigen test, or an approved alternative assay. Serologic tests will not be accepted.
-
Willing and able to complete the coronavirus disease 19 (COVID-19) symptom questionnaire prior to first dose and daily throughout the study period.
-
Initial onset of COVID-19 signs/symptoms ≤ 3 days before randomization with ≥ 2 of the following targeted symptoms, at moderate or higher severity, present at randomization.
- Stuffy or runny nose.
- Sore throat.
- Shortness of breath (difficulty breathing).
- Cough.
- Low energy or tiredness.
- Muscle or body aches.
- Headache.
- Chills or shivering.
- Feeling hot or feverish.
-
Not currently hospitalized or requiring hospitalization.
Key
- Any risk factors for progression to severe disease.
- Planning to receive a direct acting antiviral or monoclonal antibody against SARS-CoV-2 for the treatment of COVID-19.
- Received any direct acting antiviral drug or monoclonal antibody against SARS-CoV-2 for the treatment of COVID-19 < 28 days or < 5 half-lives, whichever is longer, before randomization.
- Received any convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2 prophylaxis at any time prior to study entry.
- Received an COVID-19 vaccine (including booster dose) < 120 days before randomization.
- Self-reported COVID-19 diagnosis < 120 days before randomization.
- Anticipated need for hospitalization < 48 hours after randomization.
- New oxygen requirement < 24 hours before randomization.
- Known influenza, or any other suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study drug.
- Known history of chronic liver disease, limited to cirrhosis, nonalcoholic steatohepatitis, alcoholic liver disease, and autoimmune hepatitis.
- Undergoing dialysis, or known history of chronic kidney disease.
- Persistent symptoms from previous COVID-19 illness that may interfere with the evaluation of response to the study drug.
- Pregnant or breastfeeding.
- Unwilling to use protocol-mandated contraception.
- Any other factor, including inability to complete the patient-reported outcome (PRO) questionnaire for the primary endpoint, making the individual, in the opinion of the investigator, unsuitable to participate in the study.
- Concurrent participation/enrollment in a separate therapeutic clinical study.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Obeldesivir Placebo Obeldesivir Placebo Participants will receive obeldesivir placebo twice daily for 5 days. Obeldesivir Obeldesivir Participants will receive obeldesivir 350 mg twice daily for 5 days.
- Primary Outcome Measures
Name Time Method Time to Coronavirus Disease 2019 (COVID-19) Symptom Alleviation by Day 29 First dose date up to Day 29 The time to alleviation of targeted COVID-19 symptoms by Day 29 for participants with symptom alleviation, was calculated as symptom alleviation date/time minus first dose date/time. For participants who completed Day 29 of the study or discontinued from the study before Day 29 without symptom alleviation (censored) and without inter-current events, time was calculated as last date/time on which symptom alleviation was assessed minus the first dose date/time or Day 28, whichever occurred first. Symptom alleviation was defined as, all targeted symptoms scored moderate or severe at baseline were scored as mild/none and all targeted symptoms scored mild/none at baseline were scored as none, for at least 48 consecutive hours. Targeted symptoms included: stuffy or runny nose, sore throat, shortness of breath, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering and feeling hot or feverish.
Kaplan-Meier (KM) estimates were used in outcome measure analysis.Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) First dose date up to Day 5 plus 30 days TEAEs were defined as 1 or both of the following:
* Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug.
* Any AEs leading to premature discontinuation of study drug. Percentages were rounded off.Percentage of Participants Experiencing Laboratory Abnormalities First dose date up to Day 5 plus 30 days Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days.
Percentages were rounded off.Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation First dose date up to Day 5 plus 30 days Percentages were rounded off.
- Secondary Outcome Measures
Name Time Method Time to COVID-19 Symptom Resolution by Day 29 Day 1 up to 29 COVID-19 symptom resolution was defined as all targeted symptoms scored as none for at least 48 consecutive hours. The first day of the 48 consecutive hours was considered the date of symptom resolution. The time to COVID-19 symptom resolution was the time (expressed as days) from the first dose date/time to the date/time of symptom resolution.
KM estimates were used in the outcome measure analysis.Percentage of Participants With Moderate Relapse of COVID-19 Symptoms by Day 29 Up to Day 29 COVID-19 moderate symptom relapse was defined as having at least 1 symptom being moderate or severe OR at least 2 mild symptoms OR a hospitalization for COVID-19 or death, observed on a day during COVID-19 symptom relapse.
Percentages were rounded off.Percentage of Participants With COVID-19 Related Medically Attended Visits (MAVs) or All-cause Death by Day 29 Up to Day 29 Medically attended visits were defined as interactions with health care professionals other than study staff or designees including hospitalization; in-person emergency, urgent, or primary care visits; or any other in-person visit attended by the participant and a health care professional. The nature and cause of the visit were identified.
KM estimates were used in the outcome measure analysis. Percentages were rounded off.Percentage of Participants With COVID-19 Related Hospitalization or All-cause Death by Day 29 Up to Day 29 COVID-19-related hospitalization was defined as ≥ 24 hours of acute care for a reason related to COVID-19, in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with COVID-19. This included specialized acute medical care units within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution. The date and duration (if there was 1 day difference between the start date and end date) of hospital admission, and primary reason for hospitalization (including if the hospitalization was related to COVID-19) was to be recorded.
Percentages were rounded off.Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5 Day 5 Time to Antigen Negativity Day 1 up to Day 29 Time to antigen negativity was defined (in days) as the number of days to the first date of 2 consecutive dates achieving a negative result. Antigen negativity was defined as 2 consecutive negative SARS-CoV-2 rapid antigen test (regardless if there was missing data in between), or negative test at last available sample for participants who completed or discontinued from the study after at least 1 positive antigen test.
Percentage of Participants With Viral Antigen Rebound Up to Day 29 Viral antigen rebound was defined as any positive SARS-CoV-2 rapid antigen test after antigen negativity.
Percentages were rounded off.Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir) Day 1, 0.75 hour and 2 hours; Day 3, Predose and 0.75 hour; Day 5, Predose and 0.75 hour Pharmacokinetic (PK) Parameter: AUCtau,Steady-State of GS-441524 Day 5 AUCtau is defined as the area under the concentration versus time curve over the dosing interval at steady-state.
PK Parameter: Ctau of GS-441524 Day 1 and Day 5 Ctau is defined as the observed drug concentration at the end of the dosing interval.
PK Parameter: Cmax of GS-441524 Day 1 and Day 5 Cmax is defined as the maximum observed plasma concentration of drug.
Percentage of Participants With Relapse of COVID-19 Symptoms by Day 29 Up to Day 29 Symptom relapse means at least 2 consecutive diary entries (regardless of missing data in between) where there was any symptom (regardless of severity) OR a hospitalization for COVID-19 or a death after short symptom recovery.
Percentages were rounded off.
Trial Locations
- Locations (105)
Innovative Health
🇺🇸Hollywood, Florida, United States
Palm Springs Community Health Center
🇺🇸Miami Lakes, Florida, United States
Institute for Liver Health dba Arizona Clinical Trials
🇺🇸Chandler, Arizona, United States
UHC Research, LLC
🇺🇸Doral, Florida, United States
Qway Research LLC
🇺🇸Hialeah, Florida, United States
Best Quality Research, Inc.
🇺🇸Hialeah, Florida, United States
Doral Medical Research
🇺🇸Hialeah, Florida, United States
Prestige Clinical Research Center Inc
🇺🇸Coral Gables, Florida, United States
Proactive Clinical Research,LLC
🇺🇸Fort Lauderdale, Florida, United States
Encore Medical Research, LLC
🇺🇸Hollywood, Florida, United States
Beautiful Minds Clinical Research Center
🇺🇸Cutler Bay, Florida, United States
Vital Care Research
🇺🇸Doral, Florida, United States
3Sync, LLC
🇺🇸Hialeah, Florida, United States
Essential Clinical Research
🇺🇸Miami Lakes, Florida, United States
Retreat Medical Research
🇺🇸Miami, Florida, United States
Diverse Clinical Research, LLC
🇺🇸Miami, Florida, United States
Medical corporation Shirayurikai Swing Nozaki Clinic
🇯🇵Musashino, Japan
Med-Care Research, Corp
🇺🇸Miami, Florida, United States
LCC Medical Research Institute, LLC
🇺🇸Miami, Florida, United States
Universal Medical and Research Center, LLC.
🇺🇸Miami, Florida, United States
CCM Clinical Research Group, LLC
🇺🇸Miami, Florida, United States
Global Health Clinical Trials Corp
🇺🇸Miami, Florida, United States
Verus Clinical Research, Corp
🇺🇸Miami, Florida, United States
Continental Clinical Research
🇺🇸Miami, Florida, United States
Dynamic Medical Research, LLC
🇺🇸Miami, Florida, United States
Nuren Medical & Research Center
🇺🇸Miami, Florida, United States
Advanced Care and Clinical Trials, LLC
🇺🇸Miami, Florida, United States
Bioclinical Research Alliance Inc.
🇺🇸Miami, Florida, United States
D&H National Research Centers, INC
🇺🇸Miami, Florida, United States
Florida International Medical Research
🇺🇸Miami, Florida, United States
Miami Clinical Research
🇺🇸Miami, Florida, United States
P&S Research, LLC.
🇺🇸Miami, Florida, United States
ProLive Medical Research, Corp
🇺🇸Miami, Florida, United States
Entrust Clinical Research
🇺🇸Miami, Florida, United States
MedBio Trials LLC
🇺🇸Miami, Florida, United States
Evolution Clinical Trials, INC
🇺🇸Hialeah Gardens, Florida, United States
Sato Clinic
🇯🇵Shibuya-ku, Japan
Village Health Partners
🇺🇸Plano, Texas, United States
The Crofoot Research Center, INC.
🇺🇸Houston, Texas, United States
SMS Clinical Research, LLC
🇺🇸Mesquite, Texas, United States
Shelby Clinical Research, LLC
🇺🇸Denver, North Carolina, United States
AGA Clinical Trials
🇺🇸Hialeah, Florida, United States
Research in Miami
🇺🇸Hialeah, Florida, United States
Advance Clinical Research Group
🇺🇸Miami, Florida, United States
Reed Medical Research Corp
🇺🇸Miami, Florida, United States
Velocity Clinical Research, Salt Lake City
🇺🇸West Jordan, Utah, United States
IMAX Clinical Trials, LLC
🇺🇸La Palma, California, United States
Santos Research Center, CORP
🇺🇸Tampa, Florida, United States
Precision Research Center
🇺🇸Tampa, Florida, United States
EmVenio Research
🇺🇸Fort Worth, Texas, United States
The Institute for Liver Health dba Arizona Liver Health
🇺🇸Tucson, Arizona, United States
Velocity Clinical Research, Banning (IP Delivery and Administering Location)
🇺🇸Banning, California, United States
Franco Felizarta, MD
🇺🇸Bakersfield, California, United States
Benchmark Research
🇺🇸Colton, California, United States
Velocity Clinical Research
🇺🇸Lafayette, Louisiana, United States
Ascada Research
🇺🇸Fullerton, California, United States
Om Research LLC
🇺🇸Lancaster, California, United States
L.A. Universal Research Center, INC.
🇺🇸Los Angeles, California, United States
Valley Clinical Trials
🇺🇸Northridge, California, United States
Fomat Medical Research
🇺🇸Oxnard, California, United States
Amicis Research Center
🇺🇸Northridge, California, United States
Paradigm Clinical Research
🇺🇸Redding, California, United States
Zuckerberg San Francisco General Hospital
🇺🇸San Francisco, California, United States
Clearview Medical Research, LLC
🇺🇸Santa Clarita, California, United States
Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
🇺🇸Toluca Lake, California, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Encore Medical Research of Boynton Beach LLC
🇺🇸Boynton Beach, Florida, United States
Innovative Research of West Florida, Inc
🇺🇸Clearwater, Florida, United States
Palm Harbor Dermatology d/b/a TrueBlue Clinical Research
🇺🇸Brandon, Florida, United States
Angels Clinical Research Institute
🇺🇸Tampa, Florida, United States
Quality Research of South Florida
🇺🇸Miami Lakes, Florida, United States
Southern Clinical Research LLC
🇺🇸Miami, Florida, United States
Clinical Trial Services, Corp
🇺🇸Miami, Florida, United States
Cordova Research Institute, Inc
🇺🇸Miami, Florida, United States
Allied Biomedical Research Institute
🇺🇸Miami, Florida, United States
Links Clinical Trials LLC
🇺🇸Miami, Florida, United States
Clinical Site Partners, LLC dba Flourish Research
🇺🇸Winter Park, Florida, United States
Phoenix Research Center, LLC
🇺🇸Miami, Florida, United States
Castillo Torres, MD PA
🇺🇸Palm Springs, Florida, United States
Precision Clinical Research
🇺🇸Sunrise, Florida, United States
Oceanic Research Group
🇺🇸North Miami Beach, Florida, United States
Family Clinical Trials, LLC
🇺🇸Pembroke Pines, Florida, United States
USPA Advance Concept Medical Research Group, LLC
🇺🇸South Miami, Florida, United States
Encore Medical Reseach of Weston, LLC
🇺🇸Weston, Florida, United States
Agile Clinical Research Trials, LLC
🇺🇸Atlanta, Georgia, United States
Covenant Pulmonary Critical Care Research Institute
🇺🇸East Point, Georgia, United States
Carolina Research Center, Inc.
🇺🇸Shelby, North Carolina, United States
The Brody School of Medicine at East Carolina University
🇺🇸Greenville, North Carolina, United States
Frontier Clinical Research, LLC
🇺🇸Kingwood, West Virginia, United States
St Hope Foundation, Inc.
🇺🇸Bellaire, Texas, United States
PanAmerican Clinical Research
🇺🇸Brownsville, Texas, United States
Clinovacare Medical Research Center
🇺🇸West Columbia, South Carolina, United States
Premier Pulmonary Critical Care and Sleep Medicine
🇺🇸Denison, Texas, United States
HDH Research Inc.
🇺🇸Houston, Texas, United States
Milton Haber, MD
🇺🇸Laredo, Texas, United States
STAAMP Research LLC
🇺🇸San Antonio, Texas, United States
North Texas Family Medicine
🇺🇸Plano, Texas, United States
Epic Medical Research, LLC
🇺🇸Red Oak, Texas, United States
Tranquil Clinical Research
🇺🇸Webster, Texas, United States
Bountiful Internal Medicine
🇺🇸Bountiful, Utah, United States
Nishioka Hospital
🇯🇵Sapporo-Shi Toyohira-Ku, Japan
Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai
🇯🇵Shinagawa-Ku, Japan
Kanagawa Himawari Clinic
🇯🇵Kawasaki-Shi, Japan
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Prime Global Research Inc
🇺🇸Bronx, New York, United States