Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection

SARS-CoV-2 Infection Clinical Trial

— SCORPIO-PEP  

Official title:

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of S-217622 in the Prevention of Symptomatic SARS-CoV-2 Infection in Household Contacts of an Individual With Symptomatic COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05897541
• Other study ID #: 2206T1331
• Secondary ID: 2022-002898-2820
• Status: Recruiting
• Phase: Phase 3
• Start date: June 9, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: Shionogi Inc.
• Contact: Shionogi Clinical Trials Administrator Clinical Support Help Lin
• Phone: 1-800-849-9707
• Email: Shionogiclintrials-admin[@]shionogi.co.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to measure the proportion of participants who are infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (positive reverse transcription polymerase chain reaction [RT-PCR] test) and have coronavirus disease 2019 (COVID-19) symptom(s) with S-217622 tablets compared with placebo tablets in participants who are household contacts of an individual with symptomatic COVID-19.

Description:

This study will enroll 2 types of participants: 1. those with a negative screening SARS-CoV-2 infection (referred to as "study participants"); 2. those with a positive screening SARS-CoV-2-infection (referred to as "index participants"). Study participants will receive study intervention (S-217622 or placebo), index participants will receive no study intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Index Participants

Only 1 index participant from each household will be enrolled in the study. Participants are eligible to be included as an index participant if all of the following criteria apply:

1. Pediatric participants or adult participants (of any age)

2. The index participant must:

1. Have at least 1 COVID-19 symptom within 24 hours before the index participant providing informed consent. COVID-19 symptom(s) must be deemed by the investigator as related to the current SARS-CoV-2 infection (not related to preexisting comorbidities) or deemed as preexisting and worsened due to SARS-CoV-2 infection.

2. Must have positive SARS-CoV-2 test (a nucleic acid amplification test or antigen test) from any respiratory tract specimen from a sample collected prior to randomization of the participant

3. Must have a potential study participant who can participate in the study after onset of COVID-19 symptoms in an index participant

Study Participants

Multiple study participants from the same household are allowed to be enrolled in the study. The study intervention randomization will be performed based at the study participant's level. Participants will be eligible to be included in the study only if all of the following criteria apply:

1. = 12 years of age at the time of signing the informed consent

2. Has a negative screening for SARS-CoV-2 infection, as determined by SARS-CoV-2 test (a nucleic acid amplification test or antigen test) from any respiratory tract specimen (for example, oropharyngeal, nasopharyngeal or nasal swab, or saliva).

3. Has lived in household with index participant and will continue to live in same household and share common areas such as dining rooms and bathrooms until the end of the study

4. Must not be considered by the investigator or subinvestigator to have SARS-CoV-2 infection and:

1. No measured fever at Screening (defined as body temperature = 38.0°Celsius [C] per tympanic or rectal thermometer or = 37.5°C per axillary, oral, or forehead/temporal thermometer)

2. No COVID-19 symptoms at Screening (if a participant has COVID-19-like symptoms caused by comorbidities, only 1 symptom will be allowed)

5. Capable and willing to complete a participant diary

6. a. Male participants: Participants with partners that are woman of childbearing potential (WOCBP) must agree to use effective contraception. Participants with pregnant partners must agree to use effective contraception.

b. Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and the following conditions applies:

• Is not a WOCBP or

• All of the following apply:

• Is a WOCBP and using a contraceptive method that is effective as described in the protocol.

• A WOCBP must have a negative urine pregnancy test within 24 hours before the first dose of study intervention period.

• If a urine pregnancy test cannot be confirmed as negative (for example, an ambiguous result), a serum pregnancy test must be negative.

• Additional requirements for pregnancy testing during and after study intervention as described in the protocol.

• The investigator/subinvestigator will review medical history, menstrual history, and recent sexual activity to decrease the risk of inclusion of a woman with an early undetected pregnancy.

7. Participant must be randomized = 72 hours from onset of COVID-19 symptoms in the index participant.

Exclusion Criteria:

Study Participants: Participants will be excluded from the study if any of the following criteria apply:

1. Tested positive for SARS-CoV-2 in the past 6 months.

2. Have an underlying disease requiring systemic corticosteroids (excluding topical), antipyretics/analgesics, or immunosuppressive agents.

3. Known current renal impairment defined as creatinine clearance < 30 milliliters/minute by Cockcroft Gault or requiring dialysis.

4. Participants with severe liver dysfunction, such as known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).

5. Received approved, authorized, or investigational convalescent plasma, or other anti- SARS-CoV-2 biologic products within 3 months of the Screening Visit

6. Received approved, authorized, or investigational anti-SARS-CoV-2 monoclonal antibodies (mAbs) in the last 6 months.

7. Received any SARS-CoV-2 vaccine within 6 months prior to the Screening Visit or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments until the end of the study.

8. Participants who have used any of the following drugs within 14 days prior to enrollment:

1. Strong cytochrome P450 (CYP) 3A inducer

2. Products containing St. John's wort

9. Exposed to an investigational drug within 30 days or 5 half-lives of the drug prior to the Screening Visit.

10. Positive urine pregnancy test at Screening Visit or are lactating.

11. Known allergy/sensitivity or any hypersensitivity to components of S-217622 or placebo for S-217622.

12. Any condition or circumstance that, in the opinion of the investigator or subinvestigator, would compromise the safety of the participant or the quality of the study data.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• SARS-CoV-2 Infection

Intervention

Drug:
• S-217622
Administered as a tablet.
• Placebo
Administered as a tablet.

Locations

Country	Name	City	State
Japan	Shoda Hospital	Annaka-Shi	Gunma
Japan	Suto Hospital	Annaka-shi	Gunma
Japan	Tokyo Center Clinic	Chuo-ku	Tokyo
Japan	Irie Naika Syounika Iin	Fukuoka-shi	Fukuoka
Japan	Japanese Red Cross Fukuoda Hospital	Fukuoka-shi	Hukuoka Province
Japan	Tashiro Endocrinolgy Clinic	Fukuoka-shi	Fukuoka
Japan	Tomita Internal medicine clinic	Fukuoka-shi	Fukuoka
Japan	Hamamatsu Medical Center	Hamamatsu-city	Sizuoka
Japan	Uno Internal Medicine Respiratory Clinic	Isesaki-Shi	G
Japan	Rinku General Medical Center	Izumisano-Shi	Osaka
Japan	Kamezawa Clinic	Kasugai-Shi	Aiti
Japan	Kanagawa Himawari Clinic	Kawasaki-Shi	Kanagawa
Japan	Morizono medical clinic	Kitakyushu-shi	Hukuoka
Japan	Kikuchi Internal clinic	Maebashi-Shi	Gunma
Japan	Fujimino Emergency Hospital	Miyoshi-machi, Iruma-gun	Saitama
Japan	Nozaki Clinical	Musashino-Shi	Tokyo
Japan	Nagaoka Chuo General Hospital	Nagaoka-Shi	Niigata
Japan	Nishiyamato Keiwa Hospital	Naka	Ibaraki
Japan	Shimamura Memorial Hospital	Nerima-Ku	Tokyo
Japan	Okayama University Hospital	Okayama
Japan	Osaka City Juso Hospital	Osaka
Japan	Lee's Clinic	Osaka-shi	Osaka
Japan	Denenchofu Family Clinic	Ota-ku	Tokyo Province
Japan	MIH Clinic Yoyogi	Shibuya-Ku	Tokyo
Japan	Megumi Clinic	Shimemachi	Fukuoka
Japan	Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai	Shinagawa-ku	Tokyo
Japan	Yotsuya Naika	Shinjuku-Ku	Tokyo
Japan	Fukuda Medical Clinic	Toda-shi	Saitama
Japan	KODAIRA Hospital	Toda-Shi	Saitama
Japan	Medical Corporation Kojyokai Hirose Clinic	Tokorozawa-Shi	Saitama
Japan	Nishioka Hospital	Toyohira-Ku Sapporo-Shi	Hokkaido
Japan	Tsuchiura Beryl Clinic	Tsuchiura-Shi	Ibaraki
Japan	Kaiseikai Kita Shin Yokohama Internal Medicine Clinic	Yokohama-shi	Kanagawa
Japan	Yokohama Municipal Citizens Hospital	Yokohama-shi	Kanagawa
United States	Accel Research Site - Achieve - Birmingham - ERN - PPDS	Birmingham	Alabama
United States	Central Alabama Research	Birmingham	Alabama
United States	TrueBlue Clinical Research	Brandon	Florida
United States	Voyage Medical - Michigan	Canton	Michigan
United States	ACRC Trials - Carrollton - Hunt - PPDS	Carrollton	Texas
United States	Coastal Pediatric Associates	Charleston	South Carolina
United States	Eagle Clinical Research	Chicago	Illinois
United States	Invictus Clinical Research Group, LLC	Coconut Creek	Florida
United States	Hope Clinical Trials	Coral Gables	Florida
United States	Alina Clinical Trials, LLC	Dallas	Texas
United States	Southwest Family Medicine Associates	Dallas	Texas
United States	Vida Clinical Sites	Dearborn Heights	Michigan
United States	I.V.A.M. Clinical & Investigational Center	Doral	Florida
United States	Neighborhood Healthcare	Escondido	California
United States	Apex Research Group	Fair Oaks	California
United States	Valley Institute of Research	Fort Worth	Texas
United States	Ascada Research LLC	Fullerton	California
United States	Cyn3rgy Research - ClinEdge - PPDS	Gresham	Oregon
United States	Velocity Clinical Research - Covington - PPDS	Gulfport	Mississippi
United States	Quality Research of South Florida	Hialeah	Florida
United States	Universal Medical and Research Center, LLC Homeste	Hollywood	Florida
United States	Healthstar Research	Hot Springs	Arkansas
United States	Care and Cure Clinic	Houston	Texas
United States	New Horizon Medical Group, LLC	Houston	Texas
United States	Balanced Life Health Care Solutions - SKYCRNG - PPDS	Lawrenceville	Georgia
United States	Preferred Research Partners - ClinEdge - PPDS	Little Rock	Arkansas
United States	Torrance Clinical Research Institute	Lomita	California
United States	Ark Clinical Research - Long Beach - ClinEdge - PPDS	Long Beach	California
United States	DCT-McAllen Primary Care Research, LLC dba Discove	McAllen	Texas
United States	BioClinical Research Alliance	Miami	Florida
United States	CCM Clinical Reseearch Group	Miami	Florida
United States	Continental Clinical Research, LLC	Miami	Florida
United States	Entrust Clinical Research	Miami	Florida
United States	Florida Research Center, Inc.	Miami	Florida
United States	Flourish Research - Miami - PPDS	Miami	Florida
United States	GCP Global Clinical Professionals, LLC	Miami	Florida
United States	Global Health Clinical Trials	Miami	Florida
United States	Ivetmar Medical Group, LLC	Miami	Florida
United States	Kendall South Medical Center	Miami	Florida
United States	LCC Medical Research - Miami - ClinEdge - PPDS	Miami	Florida
United States	Miami Clinical Research - ClinEdge - PPDS	Miami	Florida
United States	Oceane7 Medical & Research Center, Inc.	Miami	Florida
United States	Research Institute of South Florida Inc	Miami	Florida
United States	Suncoast Research Group LLC - Flourish - PPDS	Miami	Florida
United States	Valencia Medical and Research Center	Miami	Florida
United States	MedQuest Translational Sciences	Miami Lakes	Florida
United States	Meridian International Research	Miami Lakes	Florida
United States	Clinical Trials of South Carolina - ClinEdge - PPDS	Moncks Corner	South Carolina
United States	Accel Research Sites - Nona Pediatric Center - ERN - PPDS	Orlando	Florida
United States	Combined Research Orlando Phase I-IV LLV	Orlando	Florida
United States	CTMD Research, Inc. Palm Springs - Hunt - PPDS	Palm Springs	Florida
United States	Advances In Health Inc	Pearland	Texas
United States	American Research Centers of Florida	Pembroke Pines	Florida
United States	Absolute Clinical Research, LLC	Phoenix	Arizona
United States	Progressive Medical Research - ClinEdge - PPDS	Port Orange	Florida
United States	Rancho Cucamonga Clinical Research	Rancho Cucamonga	California
United States	Epic Medical Research LLC - Red Oak	Red Oak	Texas
United States	Smart Cures Clinical Research	Rolling Hills Estates	California
United States	Frontier Clinical Rsearch - Scottdale	Scottdale	Pennsylvania
United States	Bayside Clinical Research-West Tampa	Tampa	Florida
United States	Tampa Bay Health Care	Tampa	Florida
United States	Clinical Trials Management Services, LLC	Thousand Oaks	California
United States	Rochester Clinical Research, Inc	West Long Branch	New Jersey
United States	Progressive Medicine of the Triad, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Shionogi

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants in the Modified Intention-to-treat (mITT) Population with a Negative Screening SARS-CoV-2 Infection who are Infected with SARS-CoV-2 and Have COVID-19 Symptoms Onset		Day 1 through Day 10
Secondary	Number of Participants in the Intention-to-treat (ITT) Population with a Negative Screening SARS-CoV-2 Infection who are Infected with SARS-CoV-2 and Have COVID-19 Symptoms Onset		Day 1 through Day 10
Secondary	Number of Participants Infected with SARS-CoV-2 Regardless of Occurrence of COVID-19 Symptoms		Day 1 through Days 10, 15, or 28
Secondary	Time to the First Positive RT-PCR Result		Day 1 through Day 10
Secondary	Number of Participants with a Positive RT-PCR Result		Day 1 through Day 10
Secondary	Number of Participants Infected with SARS-CoV-2 with no COVID-19 Symptoms		Day 1 through Day 10
Secondary	Number of Participants with Sustained Resolution of all COVID-19 Symptoms		Day 1 through Day 28
Secondary	Number of Participants with Sustained Resolution of Each COVID-19 Symptom		Day 1 through Day 28
Secondary	Change in Total Score of COVID-19 Symptoms		Day 1 through Day 10
Secondary	Time From First Confirmed SARS-CoV-2 Until at Least 1 COVID-19 Symptom		Day 1 through Day 28
Secondary	Time From First Confirmed SARS-CoV-2 Until COVID-19 Symptoms Onset		Day 1 through Day 28
Secondary	Number of Participants Experiencing Hospitalization or Death from Any Cause		Day 1 through Day 28
Secondary	Plasma Concentration of S-217622		Day 3, Day 6, and Event Driven
Secondary	Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)		Day 1 through Day 28