SARS-CoV-2 InfectionPhase 3SCORPIO-PEPNCT05897541
Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection
A Phase 3 study testing S-217622 in people with SARS-CoV-2 Infection, run by Shionogi at 178 sites in 5 countries.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- S-217622
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,701 participants
- Where
- 178 sitesin 5 countries
- Study dates
- 9 Jun 2023to 18 Sep 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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:
- Pediatric participants or adult participants (of any age)
- The index participant must:
- 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.
- 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
Show all 26Show fewer
- 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:
- ≥ 12 years of age at the time of signing the informed consent
- 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).
- 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
- Must not be considered by the investigator or subinvestigator to have SARS-CoV-2 infection and:
- 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)
- No COVID-19 symptoms at Screening (if a participant has COVID-19-like symptoms caused by comorbidities, only 1 symptom will be allowed)
- Capable and willing to complete a participant diary
- 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.
- 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.
- Participant must be randomized ≤ 72 hours from onset of COVID-19 symptoms in the index participant.
Who cannot join
- Study Participants: Participants will be excluded from the study if any of the following criteria apply:
- Tested positive for SARS-CoV-2 in the past 6 months.
- Have an underlying disease requiring systemic corticosteroids (excluding topical), antipyretics/analgesics, or immunosuppressive agents.
- Known current renal impairment defined as creatinine clearance < 30 milliliters/minute by Cockcroft Gault or requiring dialysis.
- Participants with severe liver dysfunction, such as known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).
- Received approved, authorized, or investigational convalescent plasma, or other anti- SARS-CoV-2 biologic products within 3 months of the Screening Visit
Show all 16Show fewer
- Received approved, authorized, or investigational anti-SARS-CoV-2 monoclonal antibodies (mAbs) in the last 6 months.
- 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.
- Participants who have used any of the following drugs within 14 days prior to enrollment:
- Strong cytochrome P450 (CYP) 3A inducer
- Products containing St. John's wort
- Exposed to an investigational drug within 30 days or 5 half-lives of the drug prior to the Screening Visit.
- Positive urine pregnancy test at Screening Visit or are lactating.
- Known allergy/sensitivity or any hypersensitivity to components of S-217622 or placebo for S-217622.
- 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.
Trial locations and contacts
178 sites in 5 countries.
178 sites in 5 countries
United States95 sites
Saint Hope Foundation Inc
Bellaire, Texas, 77401-4500
Central Alabama Research
Birmingham, Alabama, 35209-8401
Accel Research Site - Achieve - Birmingham - ERN - PPDS
Birmingham, Alabama, 35216
TrueBlue Clinical Research
Brandon, Florida, 33511-4850
Voyage Medical - Michigan
Canton, Michigan, 48188-2866
ACRC Trials - Carrollton - Hunt - PPDS
Carrollton, Texas, 75010
Coastal Pediatric Associates
Charleston, South Carolina, 29414-5834
Olivo Medical and Wellness Center
Chicago, Illinois, 60618-8101
Eagle Clinical Research
Chicago, Illinois, 60621-3116
Invictus Clinical Research Group, LLC
Coconut Creek, Florida, 33073-3458
Lynn Institute of The Rockies - ERN - PPDS
Colorado Springs, Colorado, 80918-1662
SPICA Clinical Research
Columbia, South Carolina, 29223-6301
Universal Medical and Research Center, LLC
Coral Gables, Florida, 33134-1602
Hope Clinical Trials
Coral Gables, Florida, 33134-1642
Cullman Clinical Trials
Cullman, Alabama, 35055-1902
Global Medical Research - M3 WR
Dallas, Texas, 75224-2367
Alina Clinical Trials, LLC
Dallas, Texas, 75225-6301
Southwest Family Medicine Associates
Dallas, Texas, 75235-1715
WellNow Urgent Care & Research - Huber Heights
Dayton, Ohio, 45424-4019
PriMed Clinical Research - ClinEdge - PPDS
Dayton, Ohio, 45429-3658
Vida Clinical Sites
Dearborn Heights, Michigan, 48127-2234
Lapis Clinical Research-Denver
Denver, North Carolina, 28037-8254
Epic Medical Research LLC - DeSoto
DeSoto, Texas, 75115-2043
Henry Ford Hospital
Detroit, Michigan, 48202-2608
I.V.A.M. Clinical & Investigational Center
Doral, Florida, 33126
Child Healthcare Associates - East Syracuse
East Syracuse, New York, 13057-9305
Neighborhood Healthcare
Escondido, California, 92025-4604
Apex Research Group
Fair Oaks, California, 95628-2501
Care United Research, LLC - Elligo - PPDS
Forney, Texas, 75126-4174
Valley Institute of Research
Fort Worth, Texas, 76164-9041
Ascada Research LLC
Fullerton, California, 92835-4127
Cyn3rgy Research - ClinEdge - PPDS
Gresham, Oregon, 97030-8319
Velocity Clinical Research - Covington - PPDS
Gulfport, Mississippi, 39503-2637
Quality Research of South Florida
Hialeah, Florida, 33016-1811
Universal Medical and Research Center, LLC Homestead
Homestead, Florida, 33030-6057
Healthstar Research
Hot Springs, Arkansas, 71913-8184
C & R Research Services USA
Houston, Texas, 77022
New Horizon Medical Group, LLC
Houston, Texas, 77065
Care and Cure Clinic
Houston, Texas, 77090-1243
Alliance for Multispecialty Research, LLC - Kaysville - PPDS
Kaysville, Utah, 84037-4300
Balanced Life Health Care Solutions - SKYCRNG - PPDS
Lawrenceville, Georgia, 30046-8703
Flourish Research - Leesburg - PPDS
Leesburg, Florida, 34748-5077
Main Street Physicians Care - Waterway
Little River, South Carolina, 29566
Preferred Research Partners - ClinEdge - PPDS
Little Rock, Arkansas, 72211-3868
Torrance Clinical Research Institute
Lomita, California, 90717-2101
Ark Clinical Research - Long Beach - ClinEdge - PPDS
Long Beach, California, 90815-2521
DCT-McAllen Primary Care Research, LLC dba Discove
McAllen, Texas, 78503-1397
Premier Clinical Research Institute - Miami - ClinEdge - PPDS
Miami, Florida, 33122-1335
LCC Medical Research - Miami - ClinEdge - PPDS
Miami, Florida, 33126-1921
CCM Clinical Research Group
Miami, Florida, 33133-4231
Suncoast Research Group LLC - Flourish - PPDS
Miami, Florida, 33135-1687
University of Miami - 1150 NW 14th St
Miami, Florida, 33136-1104
Florida Research Center, Inc.
Miami, Florida, 33144-2069
Oceane7 Medical & Research Center, Inc.
Miami, Florida, 33144-2155
Continental Clinical Research, LLC
Miami, Florida, 33144-4273
BioClinical Research Alliance
Miami, Florida, 33155-6542
Ivetmar Medical Group, LLC
Miami, Florida, 33155-6542
Miami Clinical Research - ClinEdge - PPDS
Miami, Florida, 33155
Global Health Clinical Trials
Miami, Florida, 33165-2968
Valencia Medical and Research Center
Miami, Florida, 33165-3912
Alma Research
Miami, Florida, 33165
GCP Global Clinical Professionals, LLC
Miami, Florida, 33169-5732
Research Institute of South Florida Inc
Miami, Florida, 33173-4648
Entrust Clinical Research
Miami, Florida, 33176-1530
Kendall South Medical Center
Miami, Florida, 33185-4082
Flourish Research - Miami - PPDS
Miami, Florida, 33186-9066
Meridian International Research
Miami Lakes, Florida, 33014-6433
MedQuest Translational Sciences
Miami Lakes, Florida, 33016
Montana Medical Research
Missoula, Montana, 59808
Clinical Trials of South Carolina - ClinEdge - PPDS
Moncks Corner, South Carolina, 29461-5017
Combined Research Orlando Phase I-IV LLC
Orlando, Florida, 32807-3555
Central Florida Internists - Conway
Orlando, Florida, 32812-7331
Accel Research Sites - Nona Pediatric Center - ERN - PPDS
Orlando, Florida, 32829-8070
Ormond Beach Clinical Research
Ormond Beach, Florida, 32174-8196
CTMD Research, Inc. Palm Springs - Hunt - PPDS
Palm Springs, Florida, 33406-7671
Advances In Health Inc
Pearland, Texas, 77584-8075
American Research Centers of Florida
Pembroke Pines, Florida, 33027-1717
Tristar Clinical Investigations, P.C.
Philadelphia, Pennsylvania, 19114-1030
Absolute Clinical Research, LLC
Phoenix, Arizona, 85051-5775
Progressive Medical Research - ClinEdge - PPDS
Port Orange, Florida, 32127
Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, 91730-3062
Rochester Clinical Research - ATLAS - Rochester - PPDS
Rochester, New York, 14609-3173
Smart Cures Clinical Research
Rolling Hills Estates, California, 90274-7604
Alliance for Multispecialty Research LLC - Roy
Roy, Utah, 84067-9108
Clinical Associates in Research Therapeutics of America
San Antonio, Texas, 78212-4829
VIP Trials
San Antonio, Texas, 78230
Frontier Clinical Research - Scottdale
Scottdale, Pennsylvania, 15683-2460
One of a Kind Clinical Research Center LLC
Scottsdale, Arizona, 85258-4590
Renew Health Clinical Research, LLC
Tampa, Florida, 33607-2529
Bayside Clinical Research-West Tampa
Tampa, Florida, 33607
Tampa Bay Health Care
Tampa, Florida, 33615
Clinical Trials Management Services, LLC
Thousand Oaks, California, 91360
Tranquil Clinical Research
Webster, Texas, 77598-3900
KU Wichita Center for Clinical Research
Wichita, Kansas, 67214-3124
Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, 27103-1552
Japan67 sites
Toda Internal Medicine ＆ Neurology
Akashi-Shi, Hyôgo, 674-0081
Suto Hospital
Annaka-shi, Gunma, 379-0016
Shoda Hospital
Annaka-Shi, Gunma, 379-0116
Global Healthcare Clinic
Chiyoda-Ku, Tokyo, 102-0083
Tokyo Center Clinic
Chuo-ku, Tokyo, 103-0028
Nishikasai ekimae Family Clinic
Edogawa-ku, Tokyo, 134-0088
Tomita Internal medicine clinic
Fukuoka, Fukuoka, 810-0033
Irie Naika Syounika Iin
Fukuoka, Fukuoka, 812-0053
Tashiro Endocrinolgy Clinic
Fukuoka, Fukuoka, 814-0153
Japanese Red Cross Fukuoka Hospital
Fukuoka, Hukuoka Province, 815-0082
NHO Okinawa Hospital
Ginowan-Shi, Okinawa, 901-2214
Hamamatsu Medical Center
Hamamatsu, Shizuoka, 432-8580
Kijima Kids Clinic
Higashiokitama-gun, Yamagata, 999-0121
Terada Clinic Respiratory Medicine and General Practice
Himeji-shi, Hyôgo, 670-0849
Fujimaki Ear, Nose and Throat Clinic (Ent Clinic)
Ichikawa-Shi, Chiba, 272-0143
Iizuka Hospital
Iizuka-Shi, Hukuoka, 820-8505
Uno Internal Medicine Respiratory Clinic
Isesaki-Shi, Gunma, 372-0831
Rinku General Medical Center
Izumisano, Osaka, 598-0048
Moriyama Otolaryngology
Kagoshima, Kagoshima-ken, 890-0034
Kamoike Otolaryngology Clinic
Kagoshima, Kagoshima-ken, 890-0063
Murasakibaru Tahara Hospital
Kagoshima, Kagoshima-ken, 890-0082
Kamezawa Clinic
Kasugai-Shi, Aiti, 486-0817
Kasukabe Medical Center
Kasukabe, Saitama, 344-8588
Megumi Clinic
Kasuyagun Shimemachi, Fukuoka, 811-2201
Motosumiyoshi-ekimae Cocoromi Clinic
Kawasaki-Shi, Kanagawa, 211-0025
Kanagawa Himawari Clinic
Kawasaki-Shi, Kanagawa, 216-0006
Takinogawa Hospital
Kita-ku, Tokyo, 114-0023
Morizono medical clinic
Kitakyushu-shi, Hukuoka, 807-0072
Takahashi Pediatric Clinic
Kobe-Shi Nada-Ku, Hyôgo, 657-0846
Musashino Hospital
Kodaira-Shi, Tokyo, 187-0031
Takahashi Medical Clinic
Kokubunji-Shi, Tokyo, 185-0014
Kikuchi Internal clinic
Maebashi, Gunma, 370-3573
Fujimino Emergency Hospital
Miyoshi-machi, Iruma-gun, Saitama, 354-0044
Nozaki Clinical
Musashino-Shi, Tokyo, 180-0022
Nagaoka Chuo General Hospital
Nagaoka-Shi, Niigata, 940-8653
Nakayama Pediatric Clinic
Nagasaki, 852-8133
Hosokawa Surgical Clinic
Nagoya-Shi Nakamura-Ku, Aiti, 453-0812
Nishiyamato Keiwa Hospital
Naka, Ibaraki, 311-0133
Shimamura Memorial Hospital
Nerima-Ku, Tokyo, 177-0051
Okayama University Hospital
Okayama, 700-8558
University of the Ryukyus Hospital - 207 Uehara
Okinawa-Shi, Okinawa, 903-0215
Lee's Clinic
Osaka, Osaka, 531-0073
Osaka City Juso Hospital
Osaka, 532-0034
Denenchofu Family Clinic
Ōta-ku, Tokyo Province, 145-0071
Soyukai Medical Corporation Yamaguchi clinic
Ōta-ku, 145-0063
Teine Otolaryngology Clinic
Sapporo, Hokkaidô, 006-0815
Maruyama Tame Pediatrics
Sapporo, Hokkaidô, 064-0821
Nishioka Hospital
Sapporo-Shi Toyohira-Ku, Hokkaidô, 062-0034
MIH Clinic Yoyogi
Shibuya-Ku, Tokyo, 151-0051
Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai
Shinagawa-ku, Tokyo, 140-0011
Yotsuya Naika
Shinjuku-Ku, Tokyo, 160-0017
Shiwa Chuo Syounika
Shiwa-gun, 028-3318
Yoshida Clinic
Suginami-ku, Tokyo, 167-0043
Suita Municipal Hospital
Suita, Ôsaka, 564-8567
Shizuka Medical Clinic
Takasaki-shi, 370-0071
Fukuda Medical Clinic
Toda-shi, Saitama, 335-0015
KODAIRA Hospital
Toda-Shi, Saitama, 335-0035
Medical Corporation Kojyokai Hirose Clinic
Tokorozawa-Shi, Saitama, 359-1111
Ikebukuro Higashiguchi Mame Clinic
Toshima-ku, 170-0013
Hitachi,Ltd.,Tsuchiura Medical & Health Care Center
Tsuchiura, Ibaraki, 300-0012
Tsuchiura Beryl Clinic
Tsuchiura-Shi, Ibaraki, 300-0062
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576
Toyama Rosai Hospital
Uozu-Shi, Toyama, 937-0042
Nagata Hospital
Yanagawa-Shi, Hukuoka, 832-0059
Medical Corporation Nakano Children's Clinic
Yokohama, Kanagawa, 222-0012
Kaiseikai Kita Shin Yokohama Internal Medicine Clinic
Yokohama, Kanagawa, 223-0059
Yokohama Municipal Citizens Hospital
Yokohama, Kanagawa, 240-0062
Argentina11 sites
Hospital Rawson
Córdoba, 5000
Sanatorio Allende S.A
Córdoba, X5000JHQ
Hospital Interzonal General de Agudos Vicente Lopez Y Planes
General Rodriguez, Buenos Aires, 1748
Clínica Privada Independencia
Munro, Buenos Aires, 1605
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province, 5800
INECO Neurociencias Oroño
Rosario, Santa Fe Province, S2000DTP
Instituto Médico de la Fundación Estudios Clínicos
Rosario, Santa Fe Province, S2013DTC
Clínica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, Tucumán Province, T4000IHE
Centro Médico San Nicolás Grupo Oroño
San Nicolás de los Arroyos, Buenos Aires, B2900
Sanatorio Medico de Diagnostico Y Tratamiento
Santa Fe, S3000FUJ
Instituto de Investigaciones Clínicas Zárate
Zárate, Buenos Aires, B2800DGH
South Africa3 sites
Newtown Clinical Research Centre
City of Johannesburg, Gauteng, 2001
NMMM PHARMEDICA Health Research Institute
Lombardy East, Johannesburg, Gauteng, 2090
Trident Clinical
Sol Plaatjie, Northern Cape, 8301
Vietnam2 sites
University of Medicine Center, Ho Chi Minh City
Ho Chi Minh City, 700000
Hanoi University of Medicine - Clinical Trial Unit
Quận Đống Đa, Ha Noi, Thu Do, 100000
About this study
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
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.
Read the detailed 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. A total of 3701 participants will be enrolled in the study, of whom 2387 will be randomized to receive study drug or placebo, and 1314 will be enrolled as index case participants.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- S-217622, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-217622Drug
Also called XOCOVA, ensitrelvir
Administered as a tablet.
PlaceboDrug
Administered as a tablet.
| Study group | Role | What they receive |
|---|---|---|
| S-217622 | Experimental | S-217622 will be administered orally for 5 days. Receives: Drug: S-217622 |
| Placebo | Placebo comparator | Placebo matching to S-217622 will be administered orally for 5 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants in mITT Population Who Were Infected With SARS-CoV-2 and Had Coronavirus Disease 2019 (COVID-19) Symptoms Onset
Symptomatic COVID-19 was defined as a central laboratory-confirmed (CLC) positive reverse transcription polymerase chain reaction (RT-PCR) test and the occurrence (or worsening [increasing a symptom score from baseline] in the case of preexisting COVID-19-like symptoms) of >= 1 of the 14 specified COVID-19 symptoms for at least 48 hours.
Measured: Day 1 up to Day 10
Secondary outcomes (13)
Number of Participants in ITT Population With a Negative Screening SARS-CoV-2 Infection Who Were Infected With SARS-CoV-2 and Had COVID-19 Symptoms Onset
Symptomatic COVID-19 was defined as a CLC positive RT-PCR test and the occurrence (or worsening [increasing a symptom score from baseline] in the case of preexisting COVID-19-like symptoms) of >= 1 of the 14 specified COVID-19 symptoms for at least 48 hours.
Measured: Day 1 up to Day 10
Number of Participants Infected With SARS-CoV-2 Regardless of Occurrence of COVID-19 Symptoms
COVID-19 with or without symptoms onset was defined as any post baseline CLC-positive RT-PCR test.
Measured: Days 10, 15 and 28
Time to the First Central Laboratory Confirmed-Positive Reverse Transcription Polymerase Chain Reaction Result
Measured: Day 1 up to Day 28
Number of Participants With a Central Laboratory Confirmed-Positive Reverse Transcription Polymerase Chain Reaction Results
Measured: Day 1 up to Day 10
Number of Participants Infected With SARS-CoV-2 With no COVID-19 Symptoms at Day 10
Asymptomatic COVID-19 was defined as: Incident SARS-CoV-2 infection between first study intervention administration and Day 10 visit, as confirmed by CLC positive RT-PCR test, no negative RT-PCR test between (1) the day of the first positive test and (2) Day 10 visit after the first study intervention and no COVID-19 symptoms occurrence on Day 10 (or if Day 10 is missing, no symptoms recorded on the most recent diary entry prior to Day 10).
Measured: Day 10
Number of Participants Infected With SARS-CoV-2 and Had no COVID-19 Symptoms Onset Through Day 10
COVID-19 without symptoms onset was defined as any post-baseline CLC positive RT-PCR result through the Day 10 visit (up to day 11), but without any new or worsening symptoms having duration >=48 hours starting by day 10.
Measured: Day 1 up to Day 10
Number of Participants With Sustained Symptom Resolution of Each COVID-19 Symptoms
Sustained symptoms resolution was defined as >=48 hours with each symptom (except loss of taste and loss of smell) having an equal or lower symptom score relative to that symptom's baseline value.
Measured: Day 1 up to Day 28
Change From Baseline in Total Symptom Score of COVID-19 Symptoms at Day 10
Total symptom score was defined as the sum of scores for all 14 targeted symptoms (each individual symptom score was 0 = none, 1 = mild, 2 = moderate, and 3 = severe), where total score ranged 0 (none)-42 (severe symptom) and higher scores indicated severe symptoms.
Measured: Baseline, Day 10
Time From First Central Laboratory Confirmed SARS-CoV-2 Until at Least 1 COVID-19 Symptom
Time from CLC positive RT-PCR test to time of first symptoms diary reporting at least 1 COVID-19 symptom with greater-than-baseline severity through Day 28 has been reported.
Measured: Day 1 up to Day 28
Time From First Central Laboratory Confirmed SARS-CoV-2 Until COVID-19 Symptoms Onset
COVID-19 symptoms onset was defined as the occurrence (or worsening [increasing a symptom score from baseline] in the case of preexisting COVID-19-like symptoms) of >= 1 of the 14 specified COVID-19 symptoms for at least 48 hours.
Measured: Day 1 up to Day 28
Number of Participants Experiencing Hospitalization or Death From Any Cause
Hospitalization was defined as >=24 hours of acute care for any reason, in a hospital or similar acute care facility, including emergency rooms or urgent care clinics. The participants reported below were hospitalized. No participants died in the study.
Measured: Day 1 up to Day 28
Trough Concentration (Ctrough) of S-217622
Measured: Day 3
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE was defined as an AE reported after the first dose of study intervention. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured: Day 1 up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start9 Jun 2023
- Primary completion30 Aug 2024
- Study completion18 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3,701 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897541
- Sponsor's protocol ID
- 2206T1331
- Other IDs
- 2022-002898-28, 2023-503200-91-00, 2023
- Acronym
- SCORPIO-PEP
- Status last verified
- Sep 2026
- First submitted
- 6 Jun 2023
- Last updated
- 7 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hayden FG, Shinkai M, Clark TW, Luetkemeyer AF, Sax PE, Hanage WP, Gebo KA, Ikematsu H, Izumikawa K, Fukushi A, Kezbor S, Sakaguchi H, Lacey S, Ichihashi G, Ohmagari N, Uehara T; SCORPIO-PEP Study Team. Ensitrelvir for Covid-19 Postexposure Prophylaxis in Household Contacts. N Engl J Med. 2026 May 14;394(19):1905-1915. doi: 10.1056/NEJMoa2509306.
PubMed 42127390Toselli F, Jacobs S, Scheers E, Jacobs T, Doijen J, Hereijgers J, Keustermans K, Aerts L, van Heerden M, Van Loock M, Mason S, Monshouwer M, Van Damme E, Herschke F. Optimal preclinical models for human dose projection of SARS-CoV-2 small molecule direct-acting antivirals. Antiviral Res. 2026 Apr;248:106363. doi: 10.1016/j.antiviral.2026.106363. Epub 2026 Feb 9.
PubMed 41672106