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 (SCORPIO-HR)

  • End date
    Aug 17, 2023
  • participants needed
  • sponsor
Updated on 21 October 2022


The main aim of this study is to evaluate the efficacy of S-217622 versus placebo among participants who are in the subpopulation of participants who were not expected to receive standard-of-care COVID-19 Group A therapy (defined as monoclonal antibody [mAb] treatment or outpatient intravenous [IV] remdesivir).

Condition SARS-CoV-2 Infection
Treatment Placebo, S-217622
Clinical Study IdentifierNCT05305547
Last Modified on21 October 2022


Yes No Not Sure

Inclusion Criteria

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
Age ≥65 years
Feeling feverish
Diabetes mellitus
Receiving chemotherapy or other therapies for cancer
Hematologic malignancy (active or in remission)
Combined primary immunodeficiency disorder
Feeling feverish
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
Body pain or muscle pain or aches
Participants at high risk are defined as having 1 or more factors that lead to a higher risk of progression to severe COVID-19
Sore throat
Age ≥18 with 1 of the following
Nasal obstruction or congestion
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
Nasal discharge
Loss of taste or smell
One or more of the following signs/symptoms present within 24 hours prior to
Cardiovascular disease (including congenital heart disease)
Chronic lung disease (for example, chronic obstructive pulmonary disease, moderate to severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension)
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
Shortness of breath or difficulty breathing
Down syndrome
Sickle cell disease
One of the following immunocompromising conditions or immunosuppressive treatments
Body pain or muscle pain or aches
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
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)
Sore throat
Note: Current use of some corticosteroids is exclusionary, due to concern for possible
Nasal obstruction or congestion
drug-drug interaction (DDI) with S-217622
Nasal discharge

Exclusion Criteria

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 ˃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
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
Known history of cirrhosis or liver decompensation (including ascites, variceal
enrollment, locally available SARS-CoV-2 treatment (including but not limited to
bleeding, or hepatic encephalopathy)
molnupiravir, mAbs, outpatient IV remdesivir, convalescent plasma, inhaled budesonide
Participants who have used any of the following drugs within 14 days prior to
favipiravir, and fluvoxamine) will be permitted, as long as there are no concerns for
Receipt of any investigational treatments for the current episode of SARS-CoV-2 at any
Strong CYP3A inducer
time prior to randomization is exclusionary. Note: This does not include drugs
Products containing St. John's Wort
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
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
Strong cytochrome P453A (CYP 3A) inhibitor
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