Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-24 @ 1:59 PM
NCT ID:
NCT05799495
Eligibility Criteria:
Inclusion Criteria:
1. Participants ≥18 to \<65 years of age at the time of the Screening Visit.
* WOCBP may be enrolled.
* All fertile participants must agree to use a highly effective method of contraception.
2. Confirmed SARS-CoV-2 infection as determined by RAT in NP specimen collected within 48 hours prior to randomization. Investigator sites will use test kits that are authorized for use in this study and the test result must be available to confirm eligibility.
3. Initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified signs/symptoms attributable to COVID-19 present on the day of randomization.
Exclusion Criteria:
1. Current need for hospitalization or anticipated need for hospitalization within 24h after randomization in the clinical opinion of the site investigator.
2. Known medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic or active hepatitis B or C infection, primary biliary cirrhosis, Child-Pugh Class B or Class C, or acute liver failure.
3. History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator.
4. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
5. Immunocompromised with ≥1 of the following:
1. Solid organ (eg, liver, heart, lung or kidney) transplant recipient who is receiving immunosuppressive therapy.
2. Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or receiving immunosuppressive therapy.
3. Moderate or severe primary immunodeficiency (eg, DiGeorge syndrome, Wiskott-Aldrich syndrome).
4. Use of at least 1 of the following immune-weakening medications:
iii. Has received corticosteroids equivalent to prednisone ≥20 mg daily for at least 14 consecutive days within 30 days prior to study entry.
iv. Active treatment causing significant immunosuppression, including alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents, TNF blockers, or other highly immunosuppressive drugs such as biologics.
5. Hematological malignancy (including leukemia, lymphoma and myeloma) or active immunosuppressive treatment for solid tumor.
6. HIV infection with CD4 cell count \<200 mm3 from known medical history within the past 6 months of screening.
6. known severe renal impairment (eGFR of \<30 mL/min/1.73 m2 within 6 months of the screening visit, using the serum creatinine-based CKD-EPI formula12).
7. Oxygen saturation of \<92% on room air obtained at rest within 24h prior to randomization.
8. Has received or is expected to receive any other antiviral for the treatment of COVID 19, including remdesivir, PAXLOVID, molnupiravir, mAb treatment (within 30 days or 5 half-lives \[whichever is longer\] prior to screening) or received convalescent COVID-19 plasma within 12 months.
9. Expected to receive any dose of a SARS-CoV-2 vaccine within 14 days of randomization or during the study.
10. Current or previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Authorized or products with conditional approval are not considered investigational.
11. Known prior participation in this trial
12. Known history of any of the following abnormalities in clinical laboratory tests (within past 6 months of the screening visit):
* T bili ≥2 × ULN (except for Gilbert's syndrome)
* AST or ALT ≥2.5 × ULN
* Abs neutrophil count \<1000/mm3.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT05799495
Study Brief:
Protocol Section:
NCT05799495