COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43176

Dr Anil Avhad

anil.avhad@cadilapharma.co.in

2020-05-21

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

1.Healthy subjects with recent history of close contact with COVID-19 patients. <br/ >2.Subjects with SARS Cov 2 negative test (ICMR approved test kit) at screening visit. <br/ >3.Subject of either gender, age â?¥ 18 years at the time of enrollment. <br/ >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. <br/ >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 > 100°F within 3 days prior to randomization. <br/ >2.Subject with past history of COVID-19 infection. <br/ >3.Pregnant and / or lactating female subjects. <br/ >4.Presence of any illness requiring hospital referral. <br/ >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. <br/ >6.History of allergic reactions or anaphylaxis to Mw or its component.

2

Cadila Pharmaceuticals Limited

18

99

India

Close contacts to covid patients

N/A

4000

No. of subjects acquiring COVID-19 infectionTimepoint: From first dosing till 8 week post first dosing.

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "Not reported", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "Not reported", "treatment_id": 143, "treatment_name": "Autoclaved mycobacterium", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]