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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 ≤120 hours (5 days) prior to randomization |
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Age ≥65 years |
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Feeling feverish |
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Diabetes mellitus |
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Receiving chemotherapy or other therapies for cancer |
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Hematologic malignancy (active or in remission) |
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Combined primary immunodeficiency disorder |
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Feeling feverish |
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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 |
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Cough |
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Shortness of breath or difficulty breathing |
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Chills |
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Fatigue |
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Body pain or muscle pain or aches |
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Diarrhea |
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Nausea |
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Vomiting |
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Participants at high risk are defined as having 1 or more factors that lead to a higher risk of progression to severe COVID-19 |
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Headache |
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Sore throat |
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Age ≥18 with 1 of the following |
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Nasal obstruction or congestion |
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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 |
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Nasal discharge |
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Loss of taste or smell |
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Hypertension |
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One or more of the following signs/symptoms present within 24 hours prior to |
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Cardiovascular disease (including congenital heart disease) |
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randomization |
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Chronic lung disease (for example, chronic obstructive pulmonary disease, moderate to severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension) |
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Cough |
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Chronic kidney disease, as long as the participant does not have known creatinine clearance (CrCl) <30 milliliters per minute (mL/min) by Cockcroft-Gault or require dialysis |
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Shortness of breath or difficulty breathing |
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Down syndrome |
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Sickle cell disease |
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Chills |
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One of the following immunocompromising conditions or immunosuppressive treatments |
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Fatigue |
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Body pain or muscle pain or aches |
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Diarrhea |
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History of a hematopoietic stem cell or a solid organ transplant |
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Nausea |
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Human immunodeficiency virus infection: not on antiretroviral therapy or with cluster of differentiation 4+ cell count <200 cells per cubic millimeter |
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Vomiting |
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Headache |
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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) |
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Sore throat |
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Note: Current use of some corticosteroids is exclusionary, due to concern for possible |
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Nasal obstruction or congestion |
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drug-drug interaction (DDI) with S-217622 |
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Nasal discharge |
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History of hospitalization for the current SARS-CoV-2 infection (that is, prior
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hospitalization for a prior episode of SARS-CoV-2 infection is allowable)
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For the current SARS-CoV-2 infection, any positive SARS-CoV-2 molecular (nucleic acid)
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or antigen test from any respiratory tract specimen (for example, oropharyngeal, NP
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or nasal swab, or saliva) collected ˃120 hours (5 days) prior to randomization
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Participants with reinfection, defined as prior SARS-CoV-2 infection that began >90
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days prior to the current onset of symptoms with interval resolution of symptoms are
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eligible as long as the current infection has not been present for more than 5 days
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prior to randomization
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randomization
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Current need for hospitalization or immediate medical attention in the opinion of the
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investigator
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Current use of any medications prohibited with the study intervention. Use of Paxlovid
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at any time and the use of any oral, inhaled, or injectable medication intended to
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treat symptomatic SARS-CoV-2 infection before enrollment are excluded. After
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Known history of cirrhosis or liver decompensation (including ascites, variceal
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enrollment, locally available SARS-CoV-2 treatment (including but not limited to
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bleeding, or hepatic encephalopathy)
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molnupiravir, mAbs, outpatient IV remdesivir, convalescent plasma, inhaled budesonide
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Participants who have used any of the following drugs within 14 days prior to
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favipiravir, and fluvoxamine) will be permitted, as long as there are no concerns for
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enrollment
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DDIs
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Receipt of any investigational treatments for the current episode of SARS-CoV-2 at any
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Strong CYP3A inducer
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time prior to randomization is exclusionary. Note: This does not include drugs
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Products containing St. John's Wort
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approved for other uses and taken for those indications or COVID-19 vaccines. Note
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Use of locally authorized or approved therapies to prevent COVID-19, such as mAbs
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given solely to prevent COVID-19, are not exclusionary
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Any co-morbidity requiring surgery within 7 days prior to randomization or that is
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considered life threatening in the opinion of the investigator within 28 days prior to
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Known allergy/sensitivity or any hypersensitivity to components of S-217622 or placebo
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for S-217622
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Known current renal impairment defined as CrCl <30 mL/min by Cockcroft-Gault or
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requiring dialysis
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Strong cytochrome P453A (CYP 3A) inhibitor
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