Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shionogi
Age
18–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Oxygen saturation (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, SpO2 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. Note: The investigational medication may lead to an increase or decrease of sex hormone levels; therefore, hormonal contraception must not be used alone and must be combined with a barrier method.
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
You may not be if
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 estimated glomerular filtration rate \<60 milliliters/minute/1.73 meters squared 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 × 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
History of cancer except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
Women with a history of osteoporosis
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
Clareo Health | A Study of S-892216 in Participants With COVID-19
