Status:
COMPLETED
A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19
Lead Sponsor:
Shionogi
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- Nausea
- Vomiting
- Headache
- Sore throat
- Nasal obstruction or congestion
- Nasal discharge
- Participants at higher risk of progression to severe COVID-19 are defined as follows:
- Age ≥65 years
- Age ≥18 with 1 of the following:
- Obesity (body mass index \[BMI\] ≥30 kilograms per square meter \[kg/m\^2\]). Note: BMI is rounded to the nearest whole number, for example 29.5 kg/m\^2 is rounded to 30 kg/m\^2.
- Diabetes mellitus
- Hypertension requiring daily prescribed therapy
- Cardiovascular disease (requiring daily prescribed therapy or congenital heart disease)
- Chronic lung disease (for example, chronic obstructive pulmonary disease, moderate to severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension) requiring daily prescribed therapy
- Chronic kidney disease, defined as known current kidney impairment with a creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) \<60 milliliters (mL)/minute (min)/1.73 square meter (m\^2) within the past 12 months prior to randomization, as long as the participant does not have known CrCl \<30 mL/min by Cockcroft-Gault or require dialysis
- Down syndrome
- Sickle cell disease
- One of the following immunocompromising conditions or immunosuppressive treatments:
- Receiving chemotherapy or other therapies for cancer
- Hematologic malignancy (active or in remission)
- History of a hematopoietic stem cell or a solid organ transplant
- Human immunodeficiency virus infection: not on antiretroviral therapy or with cluster of differentiation 4+ cell count \<200 cells per cubic millimeter
- Combined primary immunodeficiency disorder
- Taking immunosuppressive medications (for example, drugs to suppress rejection of transplanted organs or to treat rheumatologic and gastrointestinal conditions, such as anti-tumor necrosis factor agents, mycophenolate, and rituximab).
- Note: Current use of some corticosteroids is exclusionary, due to concern for possible drug-drug interaction (DDI) with S-217622.
Exclusion
- 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
Key Trial Info
Start Date :
August 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2024
Estimated Enrollment :
2093 Patients enrolled
Trial Details
Trial ID
NCT05305547
Start Date
August 3 2022
End Date
May 24 2024
Last Update
September 16 2025
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