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 @ 12:58 PM
Ignite Modification Date:
2025-12-24 @ 12:58 PM
NCT ID:
NCT04930861
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18 and 60 years;
2. Male or female;
3. SARS-CoV-2 infection indicated by rapid test and confirmed by RT-PCR.
4. Mild or moderate COVID-19:
* The oxygen saturation in room air \>93%;
* \<30 breaths per minute;
5. No signs of hemodynamic decompensation.
6. Absence of pregnancy in women of childbearing age.
7. Able to understand and comply with the requirements of the protocol.
8. Consent to participate
Exclusion Criteria:
1. Participants in need of O2 supplementation by catheter or mask, invasive mechanical ventilation, or vasopressors.
2. Onset of symptoms or rapid test or positive RT-PCR for more than 72 hours of inclusion.
3. Participants in use or expected to use within 24 hours prior to the inclusion of drugs that are under clinical investigation as a therapeutic option for the treatment of COVID-19 (eg hydroxychloroquine, chloroquine, ivermectin, nitazoxanide, among others) during the study period;
4. Body mass index less than 19.9 or greater than 35;
5. Comorbidities such as: other serious infections, active malignancies, autoimmune diseases, liver, kidney or heart failure; another systemic disease and / or laboratory abnormality, which, in the investigator's opinion, prevent the patient from participating in the study;
6. Concomitant HIV, HBV or HCV infection.
7. Pregnancy or lactation;
8. Participation in another clinical trial in the 12 months preceding inclusion;
9. Anti-COVID-19 vaccination at any time;
10. Vaccination for any other infection in the 4 weeks prior to inclusion;
11. Any condition that increases the risk of participating in the study, in the opinion of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04930861
Study Brief:
Protocol Section:
NCT04930861