A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19

Completed · Phase 3 · Has a placebo group

Conditions studied: SARS-CoV-2 Infection

In brief

The main aim of this study is to evaluate the efficacy of S-217622 versus placebo among outpatient adults with mild and moderate COVID-19 starting intervention within 3 days of symptom onset.

Key facts

Study ID: NCT05305547
Run by: Shionogi
People needed: 2093
Starts: 2022-08-03
Expected to finish: 2024-05-24
Last updated by the study team: 2025-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Documentation of laboratory-confirmed active SARS-CoV-2 infection, as determined by a nucleic acid (for example, reverse-transcriptase PCR) or antigen test from any respiratory tract specimen (for example, oropharyngeal, NP or nasal swab, or saliva) collected ≤72 hours (3 days) prior to randomization.
Participants are expected to begin study intervention ≤3 days from self-reported date of onset of any of the COVID-19-related symptoms from the following list:
Cough
Shortness of breath or difficulty breathing
Feeling feverish
Chills
Fatigue
Body pain or muscle pain or aches
Diarrhea
Nausea
Vomiting
Headache
Sore throat
Nasal obstruction or congestion
Nasal discharge
Loss of taste
Loss of smell
One or more of the following signs/symptoms present within 24 hours prior to randomization:
Cough
Shortness of breath or difficulty breathing
Feeling feverish
Chills
Fatigue
Body pain or muscle pain or aches
Diarrhea

You may not qualify if…

History of hospitalization for the current SARS-CoV-2 infection (that is, 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 (for example, oropharyngeal, NP, or nasal swab, or saliva) collected ˃72 hours (3 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 3 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. Individuals who have used Paxlovid or any other oral, inhaled, or injectable medication intended to treat the current SARS-CoV-2 infection before randomization are excluded. After randomization, 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.
Note: Paxlovid use for a prior episode of COVID-19 is permitted.
Receipt of any investigational treatments for the current episode of SARS-CoV-2 at any time prior to randomization is exclusionary. Note: This does not include drugs approved for other uses and taken for those indications or COVID-19 vaccines. Note: Use of locally authorized or approved therapies to prevent COVID-19, such as mAbs given solely to prevent COVID-19, are not exclusionary.
Any co-morbidity 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
Known allergy/sensitivity or any hypersensitivity to components of S-217622 or placebo for S-217622
Known (within 12 months prior to randomization) 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)
Participants who have used any of the following drugs within 14 days prior to randomization:
Strong cytochrome P453A inducer
Products containing St. John's Wort

Where it is running

Voyage Medical Services — Tempe, Arizona, United States
Novak Clinical Research — Tucson, Arizona, United States
Hope Clinical Research — Canoga Park, California, United States
Carbon Health — Culver City, California, United States
NICR — Garden Grove, California, United States
Ark Clinical Research (PARENT) — Long Beach, California, United States
UCSD Antiviral Research Center — San Diego, California, United States
University of California San Francisco (PARENT) — San Francisco, California, United States
Clinical Trials Management Services, 223 E. Thousand Oaks Blvd. — Thousand Oaks, California, United States
Lundquist Institute for BMI, UCLA Medical Center — Torrance, California, United States
University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
Whitman-Walker Health — Washington D.C., District of Columbia, United States
University of Florida Clinical & Translational Science Institute — Gainesville, Florida, United States
Universal Medical and Research Center — Miami, Florida, United States
CCR Medical Center, Suite 201 — Miami, Florida, United States
Miami Clinical Research — Miami, Florida, United States
Vista Health Research, LLC — Miami, Florida, United States
Quantum Clinical Trials, 333 Arthur Godfrey Road, Suite 202, suite 208 — Miami Beach, Florida, United States
Quality Research of South Florida — Miami Lakes, Florida, United States
Accel Research Sites Network, Ormond Clinical Research Unit, 77 West Granada Boulevard — Ormond Beach, Florida, United States
Clinical Research Center of Florida, 550 SW 3rd St.,, Suite #305 — Pompano Beach, Florida, United States
Invictus Clinical Research Group, LLC — Pompano Beach, Florida, United States
Santos Research Center, CORP — Tampa, Florida, United States
Masters of Clinical Research — Augusta, Georgia, United States
Lakeview Clinical Research — Guntersville, Alabama, United States

Full record on ClinicalTrials.gov

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