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Completed
NCT05305547
A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19
Conditions: SARS-CoV-2 Infection
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 2093
Sponsor: Shionogi
Location: Lakeview Clinical Research Guntersville Alabama
Summary
The main aim of this study is to evaluate the efficacy of S-217622 versus placebo among outpatient adults with mild and moderate COVID-19 starting intervention within 3 days of symptom onset.
Eligibility Criteria
Inclusion Criteria:
* Documentation of laboratory-confirmed active SARS-CoV-2 infection, as determined by a nucleic acid (for example, reverse-transcriptase PCR) or antigen test from any respiratory tract specimen (for example, oropharyngeal, NP or nasal swab, or saliva) collected ≤72 hours (3 days) prior to randomization.
* Participants are expected to begin study intervention ≤3 days from self-reported date of onset of any of the COVID-19-related symptoms from the following list:
* Cough
* Shortness of breath or difficulty breathing
* Feeling feverish
* Chills
* Fatigue
* Body pain or muscle pain or aches
* Diarrhea
* Nausea
* Vomiting
* Headache
* Sore throat
* Nasal obstruction or congestion
* Nasal discharge
* Loss of taste
* Loss of smell
* One or more of the following signs/symptoms present within 24 hours prior to randomization:
* Cough
* Shortness of breath or difficulty breathing
* Feeling feverish
* Chills
* Fatigue
* Body pain or muscle pain or aches
* Diarrhea
* Nausea
* Vomiting
* Headache
* Sore throat
* Nasal obstruction or congestion
* Nasal discharge
* Participants at higher risk of progression to severe COVID-19 are defined as follows:
* Age ≥65 years
* Age ≥18 with 1 of the following:
* Obesity (body mass index \[BMI\] ≥30 kilograms per square meter \[kg/m\^2\]). Note: BMI is rounded to the nearest whole number, for example 29.5 kg/m\^2 is rounded to 30 kg/m\^2.
* Diabetes mellitus
* Hypertension requiring daily prescribed therapy
* Cardiovascular disease (requiring daily prescribed therapy or congenital heart disease)
* Chronic lung disease (for example, chronic obstructive pulmonary disease, moderate to severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension) requiring daily prescribed therapy
* Chronic kidney disease, defined as known current kidney impairment with a creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) \
Source: ClinicalTrials.gov (NCT05305547). StuddyBuddy aggregates publicly available trial information.