Secutrelvir: Secutrelvir will be administered orally as a tablet.
Placebo: Placebo will be administered orally as a tablet.
Study summary
The primary purpose of this study is to evaluate the efficacy and safety of secutrelvir in symptomatic nonhospitalized adult and adolescent participants with COVID-19 who are at high risk for progression to severe disease.
Eligibility
Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria:
* Must be 12 to \<18 years of age (where permitted by local regulations) with a body weight ≥40 kilograms, or ≥18 years of age regardless of body weight, at the time of signing the informed consent form.
* Presence of risk factors for progression to severe COVID-19 at the time of screening.
* Must have ≥1 COVID-19 signs/symptoms that are at least mild in severity, and the symptoms must still be present in the 24 hours prior to randomization.
* Confirmed SARS-CoV-2 infection, as determined by any SARS-CoV-2 test (for example, quantitative reverse transcription polymerase chain reaction, antigen test) approved according to local regulations, of any respiratory tract specimen (for example, oropharyngeal, nasopharyngeal or nasal swab, or saliva), collected ≤72 hours prior to randomization.
* Must be randomized within 72 hours of symptom onset, defined as the time when the first COVID-19 symptom occurs.
* Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* A women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to receiving the investigational intervention.
* Unable or unwilling to take other locally available COVID-19 antivirals (for example, nirmatrelvir/ritonavir, molnupiravir, remdesivir, ensitrelvir).
Key Exclusion Criteria:
* Planned \>24 hours hospitalization for any medical procedure through Day 28.
* Documented respiratory infection (for example, influenza, respiratory syncytial virus) other than COVID-19 within the 14 days prior to the screening visit.
* Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).
* Known history of any of the following abnormalities in the following clinical laboratory tests (within 6 months prior to the screening visit):
* Total bilirubin ≥2\*upper limit of normal (ULN) (except for Gilbert's syndrome)
* Aspartate aminotransferase or alanine aminotransferase ≥3\*ULN
* Suspected or confirmed COVID-19 unrelated to the current episode within 6 months prior to randomization or, for moderately immunocompromised participants, within 3 months prior to randomization.
* Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the investigational intervention.
* Ongoing long COVID-19 or post-acute sequelae of COVID-19 diagnosis.
* Current severely immunocompromised conditions.
* Received any other COVID-19-specific therapies within the following timeframes:
* Antiviral agents (for example, remdesivir, nirmatorelvir/ritonavir, molnupiravir, ensitrelvir) within 30 days or 5 half-lives (whichever is longer) prior to randomization
* Anti-SARS-CoV-2 monoclonal antibodies and COVID-19 convalescent plasma within 6 months prior to randomization
Note: Other protocol-define criteria apply
Primary outcome measure(s)
Proportion of Participants Experiencing Any Component of the Following Composite Endpoint: Targeted Medically Attended Visits (tMAVs) Due to Worsening COVID-19, All-cause Hospitalizations, or All-cause Deaths — Baseline through Day 28
Trial sites (34)
Facility
City
Region
Status
Hope Clinical Trials - 3970 W Flagler St.
Coral Gables
Florida
Not Yet Recruiting
Continental Clinical Research, LLC
Miami
Florida
Not Yet Recruiting
Reed Medical Research
Miami
Florida
Not Yet Recruiting
Kendall South Medical Center Inc.
Miami
Florida
Not Yet Recruiting
Global Clinical Professionals
St. Petersburg
Florida
Not Yet Recruiting
New Tampa Health
Tampa
Florida
Not Yet Recruiting
Research Bay, Inc.
Tampa
Florida
Not Yet Recruiting
Hometown Urgent Care and Research
Cincinnati
Ohio
Not Yet Recruiting
Medical Center Unimed EOOD
Sevlievo
Gabrovo
Not Yet Recruiting
Medichi Sofia - Medical Center OOD
Sofia
Sofia
Not Yet Recruiting
MCpulmo-2018 Ltd
Haskovo
Bulgaria
Not Yet Recruiting
Medical Center Medconsult Pleven - Lovech Branch
Lovech
Bulgaria
Not Yet Recruiting
Medical Center Medconsult Pleven OOD
Pleven
Bulgaria
Not Yet Recruiting
Abe Shun Naika Clinic
Kasugai-Shi
Aiti
Recruiting
Chiba Aoba Municipal Hospital
Chiba
Chiba
Not Yet Recruiting
Japan Community Health Care Organization Nihonmatsu Hospital
Nihommatsu
Fukushima
Not Yet Recruiting
Kikuchi Clinic
Maebashi
Gunma
Recruiting
Tsuchiura Beryl Clinic
Takasaki-shi
Gunma
Recruiting
Toda Internal Medicine & Neurology
Akashi-Shi
Hyôgo
Recruiting
Terada Clinic Respiratory Medicine and General Practice
Himeji-shi
Hyôgo
Recruiting
Kamezawa Clinic
Tsuchiura-Shi
Ibaraki
Recruiting
Sato Clinic
Kawasaki-shi
Kanagawa
Recruiting
Shinjo Terasu Clinic
Kawasaki-shi
Kanagawa
Recruiting
Shibasaki Internal Medicine and Pediatrics Clinic
Sendai
Miyagi
Recruiting
Matsuo Kenko Clinic
Sendai
Miyagi
Recruiting
Sugiura Clinic
Kawaguchi-shi
Saitama
Recruiting
Tokyo Center Clinic
Chuo-Ku
Tokyo
Recruiting
Nishikasai ekimae Clinic
Edogawa-ku
Tokyo
Recruiting
Morishita Ekimae Clinic
Koto-ku
Tokyo
Recruiting
Shizuka Medicine Clinic
Musashino
Tokyo
Not Yet Recruiting
Yotsuya Naika
Shibuya-Ku
Tokyo
Recruiting
Medical Corporation Shirayurikai Swing Nozaki Clinic
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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