A Randomized, Double-blind, Two arm, Placebo Controlled Clinical Trial to Evaluate the Efficacy and Safety of Mycobacterium w in preventing COVID-19 in subjects at risk of getting infected with COVID-19.

Cadila Pharmaceuticals Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Healthy subjects with recent history of close contact with COVID-19 patients.
•2.Subjects with SARS Cov 2 negative test (ICMR approved test kit) at screening visit.
•3.Subject of either gender, age >= 18 years at the time of enrollment.
•4.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 3 months post-dosing.
•5.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.

•1.Any febrile illness with oral temperature > 100Â°F within 3 days prior to randomization.
•2.Subject with past history of COVID-19 infection.
•3.Pregnant and / or lactating female subjects.
•4.Presence of any illness requiring hospital referral.
•5.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 immunosuppressantâ??s as Azathioprine, Cyclosporine, Mycophenolate etc.
•6.History of allergic reactions or anaphylaxis to Mw or its component.

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