Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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).

Official Title

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

Keywords

SARS-CoV-2 Infection COVID-19

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.
  • 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
  • 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
  • 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 high risk are defined as having 1 or more factors that lead to a higher risk of progression to severe COVID-19:
  • Age ≥65 years
  • Age ≥18 with 1 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 kg/m2 is rounded to 30 kg/m2.

  • Diabetes mellitus
  • Hypertension
  • 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
  • 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.

You CAN'T join 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 ˃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 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 enrollment, 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.
  • 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 current 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 enrollment:
  • Strong cytochrome P453A (CYP 3A) inhibitor
  • Strong CYP3A inducer
  • Products containing St. John's Wort

Locations

  • University of California San Francisco (PARENT) accepting new patients
    San Francisco California 94110 United States
  • Hope Clinical Research accepting new patients
    Canoga Park California 91303 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Shionogi
ID
NCT05305547
Phase
Phase 3 COVID-19 Research Study
Study Type
Interventional
Participants
Expecting 1729 study participants
Last Updated