A Study of S-892216 in Participants With COVID-19
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 280
- 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
-
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 a 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
Related Research Topics
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