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

• Status: Not yet recruiting
• Trial end date: 2023-08-17
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shionogi
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)

Criteria

Inclusion Criteria:

• Any of the following factors that lead to a higher risk of progression to severe COVID-19

• Individuals not fully vaccinated (see NOTE below for definition) must have one or more of the following:

• Age ≥65 years

• Age ≥18 with one of the following:

• Obesity (body mass index [BMI] ≥30 kilograms per square meter [kg/m2]). Note: BMI is rounded to the nearest whole number, for example 29.5 is rounded to 30 kg/m2

• Diabetes mellitus

• Cardiovascular disease (including congenital heart disease) or hypertension (with at least one medication recommended or prescribed)

• Chronic lung disease requiring daily therapy (for example, chronic obstructive pulmonary disease [COPD], moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension) NOTE: Fully vaccinated is defined as having received all doses to complete the initial vaccine series for COVID-19 with a vaccine that has received WHO EUL, FDA EUA, or full approval (one or two doses depending on the vaccine). Further, people who completed their initial COVID-19 vaccination course will be considered as fully vaccinated, even if they are eligible for a third vaccine dose or booster vaccination and have not received it.

• Individuals who are eligible REGARDLESS OF VACCINATION STATUS must have one or more of the following:

• Age ≥80 years

• Age ≥18 with one of the following:

• Down syndrome, sickle cell disease, dementia, Parkinson's disease, or care home residents

• One of the following immunocompromising conditions or immunosuppressive treatment:

• Receiving chemotherapy or other therapies for cancer

• Hematologic malignancy (active or in remission)

• Being within 2 years from receiving a hematopoietic stem cell or at any time following a solid organ transplant

• HIV infection untreated or with CD4+ T lymphocyte count <200 cells per cubic millimeter (mm^3) within the past 6 months

• 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-TNF agents, mycophenolate and rituximab) Note: Current use of some corticosteroids is exclusionary, due to concern for possible drug-drug interaction (DDI) with S-217622.

• Documentation of laboratory-confirmed active SARS-CoV-2 infection, as determined by a nucleic acid (for example, PCR, 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.

• 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:

• Cough

• Shortness of breath or difficulty breathing

• Fever (measured temperature >38°C [100.4°F] or subjective fever, for example, 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 or smell

• One or more of the following signs/symptoms present within 24 hours prior to randomization:

• Cough

• Shortness of breath or difficulty breathing

• Fever (documented temperature >38°C [100.4°F] or subjective fever, for example, feeling feverish)

• Chills

• Fatigue

• Body pain or muscle pain or aches

• Diarrhea

• Nausea

• Vomiting

• Headache

• Sore throat

• Nasal obstruction or congestion

• Nasal discharge

Exclusion Criteria:

• History of hospitalization for the current SARS-CoV-2 infection (for example, 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 investigator.

• Current use of or anticipated need for any medications prohibited with the study drug. Use of Paxlovid or any oral, inhaled, or injectable medication intended to treat symptomatic SARS-CoV-2 infection before or at enrollment is excluded. After enrollment, locally available SARS-CoV-2 treatment (including but not limited to molnupiravir, mAbs, outpatient administration of IV remdesivir, convalescent plasma, inhaled budesonide, 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.

NOTE: This does not include drugs approved for other uses and taken for those indications or COVID-19 vaccines.

• 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 current renal impairment defined as creatinine clearance (CrCl) <30 milliliters per minute (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 enrollment:

• Strong CYP 3A inhibitor

• Strong CYP3A inducer

• Products containing St. John's Wort