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A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19 (SCORPIO-HR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05305547
Recruitment Status : Recruiting
First Posted : March 31, 2022
Last Update Posted : September 7, 2022
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )

Tracking Information
First Submitted Date  ICMJE March 30, 2022
First Posted Date  ICMJE March 31, 2022
Last Update Posted Date September 7, 2022
Actual Study Start Date  ICMJE August 3, 2022
Estimated Primary Completion Date October 13, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2022)
Median Time to Sustained Symptom Resolution [ Time Frame: Up to Day 29 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2022)
Composite Outcome: Hospitalization From Any Cause or Death From Any Cause [ Time Frame: Up to Day 29 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2022)
  • Change From Baseline in Quantitative log10 SARS-CoV-2 RNA Levels by Polymerase Chain Reaction (PCR) on Nasopharyngeal (NP) Swab at Day 4 [ Time Frame: Baseline, Day 4 ]
  • Percentage of Participants With Adjudicated Hospitalization Due to COVID-19 or Death Due to Any Cause [ Time Frame: Up to Day 29 ]
  • Percentage of Participants With Detectable SARS-CoV-2 Viral Culture on NP Swab at Day 4 [ Time Frame: Day 4 ]
  • Median Time to Sustained Symptom Resolution Among Subgroups [ Time Frame: Up to Day 29 ]
    Subgroups will include high risk versus low risk at enrollment, COVID-19 vaccination status, receipt of COVID-19 treatments, and time from symptom onset at enrollment.
  • Percentage of Participants With Detectable SARS-CoV-2 Viral Culture on NP Swab at Day 4 Among Subgroups [ Time Frame: Day 4 ]
    Subgroups will include high risk versus low risk at enrollment, COVID-19 vaccination status, receipt of COVID-19 treatments, and time from symptom onset at enrollment.
  • Percentage of Participants With Hospitalization (All Cause) or Death Due to Any Cause [ Time Frame: Up to Day 29 ]
  • Percentage of Participants With Detectable SARS-CoV-2 Viral Culture on NP Swab at Day 8 [ Time Frame: Day 8 ]
  • Percentage of Participants With NP SARS-CoV-2 RNA Levels by Quantitative PCR Below the Lower Limit of Quantification on Days 4 and 8 [ Time Frame: Days 4 and 8 ]
  • Median Change From Baseline of SARS-CoV-2 RNA by Quantitative PCR in NP Swabs on Days 4 and 8 [ Time Frame: Baseline, Days 4 and 8 ]
  • Percentage of Participants With Undetectable Viral Culture From Nasopharyngeal Samples on Days 4 and 8 [ Time Frame: Days 4 and 8 ]
  • Median Time to Self-Reported Return to Usual (Pre-COVID-19) Health [ Time Frame: Up to Day 29 ]
  • Percentage of Participants at Each Clinical Status as Assessed by a 7-Point Ordinal Scale [ Time Frame: Day 29 ]
  • Percentage of Participants With Resting Peripheral Oxygen Saturation ≥96% [ Time Frame: Up to Day 29 ]
  • Number of Participants With Adverse Events [ Time Frame: Up to Week 24 ]
  • Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Quality of Life Score [ Time Frame: Baseline, Week 24 ]
  • Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score [ Time Frame: Baseline, Week 24 ]
  • Change From Baseline in Post-Acute COVID-19 Questionnaire [ Time Frame: Baseline, Week 24 ]
  • Percentage of Participants Who Experienced Death Due to Any Cause [ Time Frame: Up to Week 24 ]
  • Plasma Concentration of S-217622 [ Time Frame: 60 and 90 minutes postdose on Day 1 and predose on Day 4 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2022)
  • Percentage of Participants With Adjudicated Hospitalization Due to COVID-19 or Death Due to Any Cause [ Time Frame: Up to Day 29 ]
  • Percentage of Participants With Nasopharyngeal (NP) SARS-CoV-2 RNA Below the Lower Limit of Quantification (LLoQ) on Days 4 and 8 [ Time Frame: Days 4 and 8 ]
  • Median Change From Baseline of SARS-CoV-2 RNA in NP Swabs on Days 4 and 8 [ Time Frame: Baseline, Days 4 and 8 ]
  • Percentage of Participants With Undetectable Viral Culture From Nasopharyngeal Samples on Days 4 and 8 [ Time Frame: Days 4 and 8 ]
  • Median Time to Sustained Symptom Improvement [ Time Frame: Up to Day 29 ]
  • Median Time to Self-reported Return to Usual (Pre-COVID-19) Health [ Time Frame: Up to Day 29 ]
  • Percentage of Participants at Each Clinical Status as Assessed by a 7-Point Ordinal Scale [ Time Frame: Day 29 ]
  • Percentage of Participants With Resting Peripheral Oxygen Saturation ≥96% [ Time Frame: Up to Day 29 ]
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Up to Week 48 ]
  • Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Quality of Life Score [ Time Frame: Baseline, Week 48 ]
  • Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score [ Time Frame: Baseline, Week 48 ]
  • Change From Baseline in Pose-acute COVID-19 Questionnaire [ Time Frame: Baseline, Week 48 ]
  • Percentage of Participants Who Experienced Death Due to Any Cause [ Time Frame: Up to Week 48 ]
  • Plasma Concentration of S-217622 [ Time Frame: 60 and 90 minutes postdose on Day 1 and predose on Day 4 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19
Official Title  ICMJE 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
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE SARS-CoV-2 Infection
Intervention  ICMJE
  • Drug: S-217622
    Administered as a round tablet.
  • Drug: Placebo
    Administered as a round tablet.
Study Arms  ICMJE
  • Experimental: S-217622
    S-217622 will be administered orally for 5 days.
    Intervention: Drug: S-217622
  • Placebo Comparator: Placebo
    Placebo matching to S-217622 will be administered orally for 5 days.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 30, 2022)
1729
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 17, 2023
Estimated Primary Completion Date October 13, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • 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/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.
  • 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.

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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shionogi Clinical Trials Administrator Clinical Support Help Line 1-800-849-9707 Shionogiclintrials-admin@shionogi.co.jp
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05305547
Other Study ID Numbers  ICMJE ACTIV-2d/A5407
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Shionogi Inc. ( Shionogi )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Shionogi
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE Not Provided
PRS Account Shionogi Inc.
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP