Not yet recruiting NCT07746544
Study of Secutrelvir in Participants With COVID-19
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Secutrelvir, Placebo.
- Who it may be relevant to
- Registry conditions: COVID-19. Basic parameters: 12 years — 74 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Secutrelvir in Participants With COVID-19
Overview
The main purpose of this study is to compare secutrelvir to placebo with respect to resolution of clinical symptoms in nonhospitalized participants with Coronavirus Disease 2019 (COVID-19) starting intervention within 48 hours of COVID-19 symptom onset.
Interventions
- Drug Secutrelvir
Secutrelvir will be administered orally as a tablet. - Drug Placebo
Placebo will be administered orally as a tablet.
Primary outcome measures
- Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21 [Time frame: Baseline through Day 21]
Secondary outcome measures (12)
- Time to Sustained Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 28 [Time frame: Baseline through Day 28]
- Time to Sustained Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21 [Time frame: Baseline through Day 21]
- Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Symptoms Through Day 28 [Time frame: Baseline through Day 28]
- Time to First Alleviation of 14 Protocol-defined Symptoms of COVID-19 Through Day 21 [Time frame: Baseline through Day 21]
- Time to Sustained Alleviation of 14 Protocol-defined Symptoms of COVID-19 Through Day 21 [Time frame: Baseline through Day 21]
- Area Under The Curve (AUC) of Change From Baseline in Protocol-defined 14 COVID 19 Symptoms Total Score at Day 8 [Time frame: Baseline, Day 8]
- Time to First Resolution of Fever Based on Body Temperature [Time frame: Baseline through Day 28]
- Time to Sustained Resolution of Fever Based on Body Temperature [Time frame: Baseline through Day 28]
- Change From Baseline in SARS-CoV-2 Viral RNA Level [Time frame: Baseline through Day 28]
- Percentage of Participants With All-cause Hospitalization [Time frame: Baseline through Day 21]
- Percentage of Participants With All-cause Death [Time frame: Baseline through Day 21]
- Plasma Concentration of Secutrelvir and Its Metabolites [Time frame: Days 4 and 8]
Eligibility criteria
Inclusion criteria
- Must be 12 to < 18 years of age (where permitted by local regulation) with a body weight ≥ 40 kilograms (kg), or ≥ 18 and < 75 years of age regardless of body weight, at the time of signing the informed consent form (ICF).
- Must have ≥ 1 of the protocol-defined COVID-19 symptoms of moderate or severe, present within 24 hours prior to randomization.
- Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by any SARS-CoV-2 test, collected ≤ 48 hours prior to randomization.
- Must be randomized within 48 hours of COVID-19 symptom onset, defined as the time when the first COVID-19 symptom occurs.
- Agrees not to participate in another clinical study for the treatment of COVID-19 until completion of the study.
Exclusion criteria
- Current need or anticipated need for hospitalization within 24 hours, due to signs of severe COVID-19 illness or due to other medical conditions requiring hospitalization in the opinion of the site investigator.
- Documented respiratory infection (for example, influenza, respiratory syncytial virus infection) other than COVID 19 within 14 days prior to the screening visit.
- Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).
- Suspected or confirmed COVID-19 outside of the current episode within 3 months of randomization.
- Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the investigational intervention.
- Ongoing long COVID or postacute sequelae of COVID (PASC) diagnosis.
- Current severely immunocompromised conditions.
- Received or expected to receive any other COVID-19-specific therapies.
- Have previously received secutrelvir.
- Exposed to an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the screening visit.
Note: Other protocol-defined inclusion and exclusion criteria may apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Japan · 1 center
- Japanese Site 1 — Multiple Locations
Identifiers
NCT: NCT07746544 · 2512T1631