PACTR202303499747084RecruitingPhase 3
A Phase 3, multicenter, randomized, double-blind, 24-week study of the clinical and antiviral effect of S-217622 compared with placebo in non-hospitalized participants with COVID-19
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Shionogi Inc
- Enrollment
- 1,490
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 19 Year(s) to 44 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age =18 year
- •- Documentation of laboratory-confirmed active SARS-CoV-2 infection, as determined by a nucleic acid (e.g., reverse-transcriptase PCR) or antigen test from any respiratory tract specimen (e.g., oropharyngeal, NP or nasal swab, or saliva) collected =120 hours (5 days) prior to randomization.
- •- Participants are expected to begin study intervention =5 days from self-reported date of onset of any of the COVID-19-related symptoms from the following list:
- •? Shortness of breath or difficulty breathing
- •? Feeling feverish
- •? Body pain or muscle pain or aches
- •? Sore throat
- •? Nasal obstruction or congestion
- •? Nasal discharge
- •? Loss of taste or smell
- •One or more of the following signs/symptoms present within 24 hours prior to randomization (all criteria above except loss of taste or smell):
- •? Shortness of breath or difficulty breathing
- •? Feeling feverish
- •? Body pain or muscle pain or aches
- •? Sore throat
- •? Nasal obstruction or congestion
- •? Nasal discharge
- •- Oxygenation saturation of =92% on room air
- •- Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period unless meeting hospitalization criteria or reaching Day 29, whichever is earliest
- •- For participants who are of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to randomization.
Exclusion Criteria
- •- History of hospitalization for the current SARS-CoV-2 infection (i.e., prior hospitalization for a prior episode of SARS-CoV-2 infection is allowable).
- •- For the current SARS-CoV-2 infection, any positive SARS-CoV-2 molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g., oropharyngeal, NP or nasal swab, or saliva) collected ?120 hours (5 days) prior to randomization. Participants with reinfection, defined as prior SARS-CoV-2 infection that began >90 days prior to the current onset of symptoms with interval resolution of symptoms are eligible as long as the current infection has not been present for more than 5 days prior to randomization.
- •- Current need for hospitalization or immediate medical attention in the opinion of the investigator.
- •- Current use of any medications prohibited with the study intervention. Use of Paxlovid at any time and the use of any oral, inhaled, or injectable medication intended to treat symptomatic SARS-CoV-2 infection before enrollment are excluded. After enrollment, locally available SARS-CoV-2 treatment (including but not limited to molnupiravir, mAbs, outpatient IV remdesivir, convalescent plasma, inhaled budesonide, favipiravir, and fluvoxamine) will be permitted, as long as there are no concerns for DDIs.
- •- Receipt of any investigational treatments for the current episode of SARS-CoV-2 at any time prior to randomization is exclusionary.
- •- Any comorbidity requiring surgery within 7 days prior to randomization or that is considered life threatening in the opinion of the investigator within 28 days prior to randomization.
- •Currently pregnant or breastfeeding.
- •- Known allergy/sensitivity or any hypersensitivity to components of S-217622 or placebo for S-217622.
- •- Known current renal impairment defined as CrCl <30 mL/min by Cockcroft-Gault or requiring dialysis.
- •- Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy)
Investigators
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