A Study of S-892216 in Participants With COVID-19

Phase 2

Not yet recruiting

• Conditions: COVID-19
• Interventions: Drug: S-892216; Drug: Placebo

• Registration Number: NCT06928051
• Lead Sponsor: Shionogi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-09
• Study First Posted: 2025-04-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06
• Study Start: 2025-05-10
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 280

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.
• 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, oxygen saturation 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.
• 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 creatinine clearance < 30 milliliters/minute by Cockcroft Gault 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 ≥ 2.5 × 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.

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S-892216: Dose 1	S-892216	Participants will receive S-892216.
S-892216: Dose 3	S-892216	Participants will receive S-892216.
S-892216: Dose 1	Placebo	Participants will receive S-892216.
S-892216: Dose 2	S-892216	Participants will receive S-892216.
Placebo	Placebo	Participants will receive placebo.

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-time Curve (AUC) of Change From Baseline in SARS-CoV-2 Viral RNA Level Through Day 6 as Assessed by Quantitative Reverse-transcription Polymerase Chain Reaction (qRT-PCR) Testing of Nasopharyngeal (NP) Swabs	Baseline through Day 6

Secondary Outcome Measures

Name	Time	Method
Time to the First Negative SARS CoV-2 Viral RNA qRT-PCR Result	Baseline through Day 21
Time to the First SARS CoV-2 Viral RNA Viral RNA Level Less Than the Lower Limit of Quantitation (LLOQ)	Baseline through Day 21
Time to the First SARS CoV-2 Viral RNA Level Less Than the 95% LLOQ (LLOD95)	Baseline through Day 21
Number of Participants With Positive SARS CoV-2 Viral RNA qRT-PCR Result	Baseline, Days 2, 4, 6, 14, and 21
Change From Baseline in SARS CoV-2 Viral RNA Level	Baseline, Days 2, 4, 6, 14, and 21
Time to Sustained (2 Consecutive Days) Resolution of COVID-19 Symptoms	Baseline through Day 28
Time to First Resolution of COVID-19 Symptoms	Baseline through Day 28
Time to Return to Pre-COVID-19 Health	Baseline through Day 28
Plasma Concentration of S-892216	Day 2 and Day 6