Clinical trial NCT06928051: A Study of S-892216 in Participants With COVID-19
Official title: Phase 2 Study of S-892216 in Participants Infected With SARS-CoV-2
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: COVID-19
Keywords: S-892216
3CL
Protease Inhibitor
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-15
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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.

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