SARS-CoV-2 infection MedDRA version: 23.0 Level: LLT Classification code 10084272 Term: SARS-CoV-2 infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: S-217622
Pharmaceutical Form: Tablet
INN or Proposed INN: Not established
Current Sponsor code: S-217622B
Other descriptive name: S-217622B
Concentration unit: mg milligram(s)
Concentr
Sponsors
Shionogi B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For all participants -Ability and willingness of participant to provide informed consent prior to initiation of any study procedures. -Age =18 years. -Documentation of laboratory-confirmed active SARS-CoV-2 infection, as determined by a nucleic acid (e.g., reverse-transcriptase PCR) or antigen test from any respiratory tract specimen (e.g., 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 selfreported date of onset of any of the COVID-19-related symptoms as described in the study protocol. For high-risk participants (excluded in the US) Participants at higher risk of progression to severe COVID-19 are defined as follows: ? Age =65 years ? Age =18 with 1 of the following: o Obesity (body mass index [BMI] =30 kg/m2). Note: BMI is rounded to the nearest whole number, for example 29.5 kg/m2 is rounded to 30 kg/m2. o Diabetes mellitus o Hypertension requiring daily prescribed therapy o Cardiovascular disease requiring daily prescribed therapy or congenital heart disease o Chronic lung disease (e.g., chronic obstructive pulmonary disease [COPD], moderate to severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension) requiring daily prescribed therapy o Chronic kidney disease, defined as known current kidney impairment with a creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) =65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: -History of hospitalization for the current SARS-CoV-2 infection (i.e., 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 (e.g., 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, as described in Section 5.4.2 of the protocol. 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 as outlined in Section 5.4.2. of the protocol 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if S-217622 will reduce the time to sustained symptom resolution through Day 29 among outpatient adults with mild and moderate COVID-19 starting intervention within 3 days of symptom onset. Time to sustained symptom resolution is defined as the time from start of study intervention to the first day of 2 consecutive days with complete resolution of COVID-19 symptoms on participant selfassessment AND alive and without hospitalization for any reason by Day 29 and will be compared using restricted mean symptom duration up to Day 28, which is the last timepoint at which the outcome can be achieved. Hospitalization is defined as =24 hours of acute care, in a hospital or similar acute care facility, including emergency rooms, urgent care clinics, or facilities instituted to address medical needs of those with COVID-19;Secondary Objective: To determine whether S-217622 reduces COVID-19- related hospitalization (adjudicated) and all deaths regardless of occurrence outside of hospital or during hospitalization (not adjudicated) through Day 29 among outpatient adults with SARS-CoV-2 starting intervention within 3 days of symptom onset. To determine if S-217622 will reduce the time to sustained symptom resolution through Day 29 among all outpatient adults with SARS-CoV-2. To determine the effect of S-217622 compared with placebo on: - To determine the change from baseline in quantitative log10 SARSCoV-2 RNA levels by PCR on NP swab at Day 4 among all outpatient adults with SARS-CoV-2 (and when starting intervention within 3 days of symptom onset). - on the occurrence of persistent and/or late-onset symptoms of COVID19 at Week 12 among all outpatient adults with SARS-CoV-2 (and when starting intervention within 3 days of symptom onset). ;Primary end point(s): Symptom duration for all targeted symptoms (including those occurring prior to COVID-19 infection): Time (days) from start of S-217622 or placebo (Day 1) until sustained resolution and being al | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary virologic outcome: change from baseline in quantitative log SARS-Cov-2 RNA levels by PCR on NP swab at Day 4 among outpatient adults with SARS-CoV-2. Key secondary clinical outcome: The composite of COVID-19-related hospitalization (adjudicated) and all deaths regardless of occurrence outside of hospital or during hospitalization (not adjudicated) through Day 29 among outpatient adults with SARS-CoV-2 starting intervention within 3 days of symptom onset. Key secondary clinical outcome: The proportion of participants with persistent and/or late-onset symptoms of COVID-19 at Week 12 based on participants' assessments of the 5 symptoms specified by the WHO (fatigue, shortness of breath/difficulty breathing, difficulty with concentration/ thinking, difficulty reasoning/solving problems, and memory loss) plus taste disturbance and smell disturbance among outpatient adults with SARS-CoV-2 starting intervention within 3 days of symptom onset. ;Timepoint(s) of evaluation of this end point: virologic outcome: Day 4 clinical outcome: Day 1 to Day 29 | — |
Countries
Argentina, Brazil, Colombia, Egypt, Ghana, India, Japan, Kenya, Malawi, Mexico, Pakistan, Philippines, Poland, Puerto Rico, South Africa, Thailand, Türkiye, Uganda, United States
Contacts
Public ContactCorporate Communications Department
Shionogi & Co., Ltd
Outcome results
None listed