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 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT05092503
Eligibility Criteria:
Inclusion Criteria:
1. Adult ≥ 18 years and ≤ 50 years of age, BMI \< 30 at time of enrollment.
2. Have presence of SARS-CoV-2 infection confirmed by reverse transcription polymerase chain reaction (RT-PCR) test with sample collection ≤ 3 days prior to randomization.
3. Fever ≥ 38.0℃ (100.4℉ oral temperature) or ≥ 38.6℃ (101.48℉ tympanic temperature) within 48 hours before screening; and at least one of respiratory rate \> 24 breaths/minute or cough (scored ≥ 2 via participant questionnaire).
4. Initial onset of signs/symptoms for ≤ 5 days prior to randomization.
5. Participant provides written informed consent prior to initiation of any study procedures.
6. Participant is willing to accept randomization to any assigned treatment arm. And participant understands and agrees to comply with planned study procedures.
Exclusion Criteria:
1. SARS-CoV-2 infection confirmed participants who are currently hospitalized or are expected to need hospitalization (for COVID-19 within 48 hours of randomization).
2. Participants who have SpO2 ˂ 93% on room air at sea level, or respiratory frequency ˃ 30 breaths/minute, or heart rate ≥ 125 per minute.
3. Require mechanical ventilation or anticipated impending need for mechanical ventilation.
4. Pre-existing pulmonary conditions such as chronic obstructive pulmonary disease or asthma. Imaging confirmed the existence of severe lung interstitial lesions, bronchiectasis, bronchopulmonary dysplasia and other basic pulmonary diseases. Have chronic pulmonary diseases such as pulmonary embolism and pulmonary hypertension at present.
5. Have any other active infectious diseases. Such as influenza, bacterial infections of the respiratory system (suppurative tonsillitis, acute tracheobronchitis, active tuberculosis, etc.) and other respiratory diseases affecting the evaluation of clinical trials.
6. ALT/AST \> 3×ULN, TBIL ≥ 1.5×ULN, creatinine ≥ 1.5×ULN.
7. Patients with recurrent diarrhea or abnormal intestinal function that are not caused by COVID-19.
8. Patients with a history of type 1 or type 2 diabetes, OR with glycosylated hemoglobin (HbA1c) level ≥ 6.5% during screening.
9. Patients with hypertension at screening (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg).
10. Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study. Such as, unresectable malignant tumor, blood disease, active bleeding, cachexia, nervous system disease, endocrine system disease, cardiovascular disease and heart conditions (e.g., heart failure \[New York heart association (NYHA) ≥ grade 3\], coronary artery disease, cardiomyopathies), down syndrome, sickle cell disease, cystic fibrosis, thalassemia, etc.
11. Suffering from diseases that seriously affect the immune system, such as HIV infection, splenectomy, organ or blood stem cell transplantation, etc.
12. Participants who received systemic corticosteroids or other immunosuppressive medications within 14 days before screening.
13. Participants with positive results of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) at screening period.
14. Participants who are using any herb supplements/products.
15. Participants who are currently using anti-virus drugs.
16. Nursing women or women of pregnancy test positive or planning to be pregnant throughout the study period.
17. Psychiatric or cognitive illness (such as schizophrenia spectrum disorders, mood disorders, dementia, etc.) or alcohol abuse.
18. Participants who have received any interventional experimental treatment for COVID-19 within the 30 days prior to the time of the screening evaluation.
19. Participants unable to take oral medications.
20. Participants who plan to receive live attenuated vaccine within 1 month prior to the first administration of the study drug or during the study period.
21. Participants with mild to moderate COVID-19 who would be eligible for another FDA authorized COVID-19 therapeutic.
22. Participants who are on sensitive substrates or substrates of a narrow therapeutic range for major cytochrome P450 and transporters.
23. Other conditions inappropriate for participation in this clinical trial considered by the investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05092503
Study Brief:
Protocol Section:
NCT05092503