COVID-19
Conditions
Interventions
Sponsors
Gomez Juan Carlos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Must be >= 18 and = 40 kg. -Must have >= 2 of COVID-19 signs/symptoms of mild or higher severity, or >= 1 signs/symptoms of moderate or higher severity, within the 72 hours prior to randomization, and the symptoms must still be present in the 24 hours prior to randomization. -Documentation of laboratory-confirmed active SARS-CoV-2 infection, as determined by a nucleic acid (eg, qRT-PCR) or antigen test from any respiratory tract specimen (eg, oropharyngeal, NP or nasal swab, or saliva), or any other SARS-CoV-2 test approved according to local regulations, collected = 92% on room air adjusted for altitude and obtained at rest by study staff within the 24 hours prior to randomization. -Male or female
Exclusion criteria
Exclusion criteria: -Are at high risk of progression to severe COVID-19. -Documented respiratory infection (eg, influenza, respiratory syncytial virus) other than COVID 19 within the 14 days prior to the screening visit. -History of hospitalization for the current SARS-CoV-2 infection or anticipated need for hospitalization within 24 hours after randomization. -Received or expected to receive any dose of a SARS-CoV-2 vaccine within 14 days of randomization or during the study through day 28. -Received or expected to receive any other COVID-19-specific treatment, including outpatient remdesivir, Paxlovid, molnupiravir, monoclonal antibodies (mAbs), ensitrelvir, and convalescent plasma for the current COVID-19 infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in SARS-CoV-2 viral RNA level by qRT-PCR (NP swabs) on day 4 | — |
Countries
Japan, The United States
Contacts
Public ContactCorporate Communications Department
Shionogi & Co., Ltd.
Outcome results
None listed