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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT04353518
Eligibility Criteria:
Inclusion Criteria:
* Healthy subjects of either gender, age ≥ 18 years, with recent history of close contact with COVID-19 patients.
* Subjects with SARS Cov 2 negative test (ICMR approved test kit) at screening visit.
* Female subject who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least months post-dosing.
* The subject must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form.
Exclusion Criteria:
* Any febrile illness with oral temperature \> 100°F within 3 days prior to randomization.
* Subject with past history of COVID-19 infection.
* Pregnant and / or lactating female subjects.
* Presence of any illness requiring hospital referral.
* Any confirmed or suspected immune-deficient condition based on medical history and physical examination and a family history of congenital or hereditary immunodeficiency or Individuals on immunosuppressant's as Azathioprine, Cyclosporine, Mycophenolate etc.
* History of allergic reactions or anaphylaxis to Mw or its component.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04353518
Study Brief:
Protocol Section:
NCT04353518