Official Title
Phase 2 Study of S-892216 in Participants Infected With SARS-CoV-2
Brief Summary

The primary objective of this study is to investigate the antiviral effect of S-892216 inparticipants with coronavirus disease 2019 (COVID-19) due to severe acute respiratorysyndrome coronavirus 2 (SARS-CoV-2) infection.

Detailed Description

Not Provided

Recruiting
COVID-19

Drug: S-892216

S-892216 will be administered orally as a tablet.

Drug: Placebo

Placebo will be administered orally as a tablet.

Eligibility Criteria

Key Inclusion Criteria:

- Must weigh ≥40 kilograms

- Must have at least 2 COVID-19 signs/symptoms of mild or higher severity, or at least
1 sign/symptom of moderate or higher severity, within the 72 hours prior to
randomization, and the symptoms must still be present in the 24 hours prior to
randomization

- Documentation of laboratory-confirmed active SARS-CoV-2 infection, as determined by
a nucleic acid (for example, qRT-PCR) or antigen test from any respiratory tract
specimen (for example, oropharyngeal, NP or nasal swab, or saliva), or any other
SARS-CoV-2 test approved according to local regulations, collected ≤72 hours (3
days) prior to randomization

- Oxygen saturation (SpO2) of ≥92% on room air adjusted for altitude and obtained at
rest by study staff within the 24 hours prior to randomization. For a potential
participant who regularly receives chronic supplementary oxygen for an underlying
lung condition, SpO2 measured while on standard home oxygen supplementation level
must be ≥92%.

- Capable and willing to complete an electronic participant diary

- Contraceptive use by female participants should be consistent with local regulations
regarding the use of contraceptive methods for those participating in clinical
studies. Note: The investigational medication may lead to an increase or decrease of
sex hormone levels; therefore, hormonal contraception must not be used alone and
must be combined with a barrier method.

- A woman of childbearing potential must have a negative urine pregnancy test within
the 24 hours before the first dose of investigational intervention

- Must be randomized ≤72 hours from onset of COVID-19 symptoms (defined as the time
point when at least 1 of the COVID-19 symptoms occurs)

- Agrees to not participate in another clinical trial for the treatment of COVID-19 or
SARS-CoV-2 during the study period unless meeting hospitalization criteria or
reaching Day 28, whichever is earliest

Key Exclusion Criteria:

- High risk of progression to severe COVID-19, as defined in the protocol

- Documented respiratory infection (for example, influenza, respiratory syncytial
virus) other than COVID-19 within the 14 days prior to the screening visit

- Known current renal impairment defined as estimated glomerular filtration rate <60
milliliters/minute/1.73 meters squared or requiring dialysis

- Known history of cirrhosis or liver decompensation (including ascites, variceal
bleeding, or hepatic encephalopathy)

- Known history of any of the following abnormalities in the following clinical
laboratory tests (within the 6 months prior to the screening visit):

- Total bilirubin ≥2 × upper limit of normal (ULN) (except for Gilbert's
syndrome)

- Aspartate aminotransferase or alanine aminotransferase ≥2 × ULN

- A QT interval corrected using Fridericia's formula at the screening visit:

- For males: >450 milliseconds (msec)

- For females: >470 msec

- History of hospitalization for the current SARS-CoV-2 infection or anticipated need
for hospitalization within 24 hours after randomization

- History of cancer except for basal cell or squamous epithelial carcinomas of the
skin that have been resected with no evidence of metastatic disease for 3 years

- Women with a history of osteoporosis

- Received or expected to receive any dose of a SARS-CoV-2 vaccine within 14 days of
randomization or during the study through day 28

- Received or expected to receive any other COVID-19-specific treatment, including
outpatient remdesivir, Paxlovid, molnupiravir, monoclonal antibodies, ensitrelvir,
and convalescent plasma for the current COVID-19 infection

- Exposed to an investigational drug within 30 days or 5 half-lives of the drug prior
to the screening visit

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 64 Years
Countries
Japan
United States
Locations

Healthstar Research
Hot Springs, Arkansas, United States

Palm Springs Community Health Center
Miami Lakes, Florida, United States

Quality Research of South Florida
Miami Lakes, Florida, United States

Oceane7 Medical & Research Center, Inc.
Miami Lakes, Florida, United States

Care United Research, LLC
Forney, Texas, United States

Japanese Site 10
Multiple Locations, Japan

Japanese Site 11
Multiple Locations, Japan

Japanese Site 12
Multiple Locations, Japan

Japanese Site 13
Multiple Locations, Japan

Japanese Site 14
Multiple Locations, Japan

Japanese Site 15
Multiple Locations, Japan

Japanese Site 16
Multiple Locations, Japan

Japanese Site 17
Multiple Locations, Japan

Japanese Site 18
Multiple Locations, Japan

Japanese Site 19
Multiple Locations, Japan

Japanese Site 1
Multiple Locations, Japan

Japanese Site 20
Multiple Locations, Japan

Japanese Site 21
Multiple Locations, Japan

Japanese Site 22
Multiple Locations, Japan

Japanese Site 23
Multiple Locations, Japan

Japanese Site 24
Multiple Locations, Japan

Japanese Site 25
Multiple Locations, Japan

Japanese Site 26
Multiple Locations, Japan

Japanese Site 27
Multiple Locations, Japan

Japanese Site 28
Multiple Locations, Japan

Japanese Site 2
Multiple Locations, Japan

Japanese Site 3
Multiple Locations, Japan

Japanese Site 4
Multiple Locations, Japan

Japanese Site 5
Multiple Locations, Japan

Japanese Site 6
Multiple Locations, Japan

Japanese Site 7
Multiple Locations, Japan

Japanese Site 8
Multiple Locations, Japan

Japanese Site 9
Multiple Locations, Japan

Contacts

Shionogi Clinical Trials Administrator Clinical Support Help Line
1-800-849-9707
Shionogiclintrials-admin@shionogi.co.jp

Not Provided

NCT Number
Keywords
S-892216
Mpro
main protease
Nonstructural Protein 5
nsp5
Protease inhibitor
MeSH Terms
COVID-19