Study of Obeldesivir in Nonhospitalized Participants With COVID-19

NCT05715528
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Phase
Phase 3
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Recruitment status
Completed
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Participants
2,011
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Lead sponsor
Gilead Sciences
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Start date
2023-02-08
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Number of sites
113
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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.
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Acronym
OAKTREE
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Short title
Study of Obeldesivir in Nonhospitalized Participants With COVID-19
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Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Nonhospitalized Participants
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Control arm
Placebo
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2024-01-23
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First posted
2023-02-08
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Registry last updated
2024-12-24
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Primary completion date
2023-11-28
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Start date
2023-02-08
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Actual participants
2,011
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Participants
2,011
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Participant count basis
Actual
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Protocol amendments
5
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Number of sites
113
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Gilead Sciences
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05715528
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ClinicalTrials.gov ID
NCT05715528
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masking description
Participants, personnel directly involved in the conduct of study, and sponsor will not know the treatment participants received.
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Time to Coronavirus Disease 2019 (COVID-19) Symptom Alleviation by Day 29

    Timeframe: 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.

  2. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Timeframe: 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.

  3. Percentage of Participants Experiencing Laboratory Abnormalities

    Timeframe: 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.

  4. Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation

    Timeframe: First dose date up to Day 5 plus 30 days

    Percentages were rounded off.

  1. Time to COVID-19 Symptom Resolution by Day 29

    Timeframe: 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.

  2. Percentage of Participants With Moderate Relapse of COVID-19 Symptoms by Day 29

    Timeframe: 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.

  3. Percentage of Participants With COVID-19 Related Medically Attended Visits (MAVs) or All-cause Death by Day 29

    Timeframe: 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.

  4. Percentage of Participants With COVID-19 Related Hospitalization or All-cause Death by Day 29

    Timeframe: 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.

  5. Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5

    Timeframe: Day 5

  6. Time to Antigen Negativity

    Timeframe: 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.

  7. Percentage of Participants With Viral Antigen Rebound

    Timeframe: 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.

  8. Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)

    Timeframe: Day 1, 0.75 hour and 2 hours; Day 3, Predose and 0.75 hour; Day 5, Predose and 0.75 hour

  9. Pharmacokinetic (PK) Parameter: AUCtau,Steady-State of GS-441524

    Timeframe: Day 5

    AUCtau is defined as the area under the concentration versus time curve over the dosing interval at steady-state.

  10. PK Parameter: Ctau of GS-441524

    Timeframe: Day 1 and Day 5

    Ctau is defined as the observed drug concentration at the end of the dosing interval.

  11. PK Parameter: Cmax of GS-441524

    Timeframe: Day 1 and Day 5

    Cmax is defined as the maximum observed plasma concentration of drug.

  12. Percentage of Participants With Relapse of COVID-19 Symptoms by Day 29

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children, Adults
Minimum age
12 Years
Maximum age
64 Years
Healthy volunteers
No

Key Inclusion Criteria:

  • 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 Exclusion Criteria:

  • 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.

Sources for eligibility
clinicaltrials.gov

  • EmVenio ResearchAlabaster, United States
  • Institute for Liver Health dba Arizona Clinical TrialsChandler, United States
  • The Institute for Liver Health dba Arizona Liver HealthTucson, United States
  • Franco Felizarta, MDBakersfield, United States
  • Velocity Clinical Research, Banning (IP Delivery and Administering Location)Banning, United States
  • Benchmark ResearchColton, United States
  • Ascada ResearchFullerton, United States
  • Velocity Clinical ResearchLa Mesa, United States
  • IMAX Clinical Trials, LLCLa Palma, United States
  • Om Research LLCLancaster, United States
  • L.A. Universal Research Center, INC.Los Angeles, United States
  • Amicis Research CenterNorthridge, United States
  • Valley Clinical TrialsNorthridge, United States
  • Fomat Medical ResearchOxnard, United States
  • Paradigm Clinical ResearchRedding, United States
  • Zuckerberg San Francisco General HospitalSan Francisco, United States
  • Clearview Medical Research, LLCSanta Clarita, United States
  • EmVenio ResearchSanta Monica, United States
  • Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.Toluca Lake, United States
  • Georgetown University Medical CenterWashington D.C., United States
  • Encore Medical Research of Boynton Beach LLCBoynton Beach, United States
  • Palm Harbor Dermatology d/b/a TrueBlue Clinical ResearchBrandon, United States
  • Innovative Research of West Florida, IncClearwater, United States
  • Prestige Clinical Research Center IncCoral Gables, United States
  • Beautiful Minds Clinical Research CenterCutler Bay, United States

And 88 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • jRCT2031230285
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)