Can a new pill shorten COVID-19 symptoms?
NCT ID NCT07746544
First seen Aug 05, 2026 · Last updated Sep 03, 2026 · Updated 3 times
Summary
This phase 3 trial is testing whether the oral drug secutrelvir can help people with COVID-19 recover faster. The study involves about 1,200 nonhospitalized participants aged 12 to 75 who start treatment within 48 hours of symptom onset. Half will receive secutrelvir and half a placebo, and researchers will track how quickly 14 common COVID-19 symptoms resolve. The goal is to see if secutrelvir can shorten the illness and improve outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Secutrelvir (also known as S-892216), an oral antiviral drug taken as a tablet
- What this could lead to
- If successful, secutrelvir could become a new treatment option to help people with COVID-19 feel better faster and reduce the burden of the disease.
- What could go wrong
- This is a phase 3 trial, but results are not guaranteed. The drug may not significantly speed up symptom resolution, and there could be side effects not yet fully known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 74 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * Must be 12 to \< 18 years of age (where permitted by local regulation) with a body weight ≥ 40 kilograms (kg), or ≥ 18 and \< 75 years of age regardless of body weight, at the time of signing the informed consent form (ICF). * Must have ≥ 1 of the protocol-defined COVID-19 symptoms of moderate or severe, present within 24 hours prior to randomization. * Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by any SARS-CoV-2 test, collected ≤ 48 hours prior to randomization. * Must be randomized within 48 hours of COVID-19 symptom onset, defined as the time when the first COVID-19 symptom occurs. * Agrees not to participate in another clinical study for the treatment of COVID-19 until completion of the study. Key Exclusion Criteria: * Current need or anticipated need for hospitalization within 24 hours, due to signs of severe COVID-19 illness or due to other medical conditions requiring hospitalization in the opinion of the site investigator. * Documented respiratory infection (for example, influenza, respiratory syncytial virus infection) other than COVID 19 within 14 days prior to the screening visit. * Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy). * Suspected or confirmed COVID-19 outside of the current episode within 3 months of 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 or postacute sequelae of COVID (PASC) diagnosis. * Current severely immunocompromised conditions. * Received or expected to receive any other COVID-19-specific therapies. * Have previously received secutrelvir. * Exposed to an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the screening visit. Note: Other protocol-defined inclusion and exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Japanese Site 1
RECRUITINGMultiple Locations, Japan
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Other studies related to the condition(s) this trial covers.
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- Can lung ultrasound reveal COVID-19's signature in the lungs?
- When the immune system Can't fight back: tracking three respiratory viruses
- The household maze: how does COVID-19 move between family members?
- Can an oral drug stop COVID-19 from turning deadly?
- Can COVID-19 rapid tests slip into HIV and TB clinics without disrupting care?