COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50812

Narinder Pal Singh

NANUSINGH58@GMAIL.COM

2020-12-29

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

1.Healthy subjects of either gender, age â?¥ 18 years. <br/ >2.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. <br/ >3.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. <br/ >

1. Any febrile illness with oral temperature &gt, 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 <br/ >physical examination and a family history of congenital or hereditary immunodeficiency <br/ >or Individuals on immunosuppressant&#39,s as Azathioprine, Cyclosporine, Mycophenolate <br/ >etc. <br/ >6. History of allergic reactions or anaphylaxis to Mw or its component.

2

SGT University

18

70

India

Healthy volunteers

N/A

300

To evaluate the incidence of RT-PCR proved COVID-19 in Mw treated group in comparison to control group.Timepoint: 6 month

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

Phase 3

[{"arm_notes": "", "treatment_id": 843, "treatment_name": "Mycobacterium indicus pranii", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]