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:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT04373733
Eligibility Criteria:
Inclusion Criteria:
1. Adult participants: Signed informed consent
2. New admission to hospital for period expected to last ≥ 1 night
3. Suspected or confirmed COVID-19 infection
Patients are suspected of COVID-19 infection if they have the following:
· Influenza like illness (fever ≥37.8°C and at least one of the following respiratory symptoms, which must be of acute onset: persistent cough, hoarseness, nasal discharge or congestion, shortness of breath, sore throat, wheezing or sneezing).
And
· Finding from either a chest x-ray or CT suggestive of Covid-19 infection
And
· Alternative causes are considered unlikely
4. For women to be eligible to enter and participate in the study they should be: of non-child-bearing
* potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,
* or of child-bearing potential have a negative pregnancy test at screening and agrees to remain sexually abstinent or use a method of contraception with a failure rate of \< 1% per year as indicated in Appendix B during the treatment and for a period of 7 days after the last dose. Hormonal contraceptive methods must be supplemented by a barrier method.
5. Men who are sexually active must use an adequate method of contraception as listed in Appendix B, for a period of at least 7 days after the last dose
Exclusion Criteria:
1. Pregnant or breast feeding, due to potential teratogenicity
2. Hepatic impairment - (AST or ALT \> 3.5 x upper limit of normal)
3. Presently enrolled in an interventional drug study
4. Unable to take medication via the oral or nasogastric route
5. Known sensitivity Favipiravir
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04373733
Study Brief:
Protocol Section:
NCT04373733