COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47197

Dr Dharampal Singh Sudan

hod.tbchest@sgtuniversity.org

2020-09-10

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

1.Laboratory confirmed symptomatic COVID-19 patients with ordinal scale of 3& 4. <br/ >2.Female patients 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/ >3.The patients 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.Patient with ordinal scale of â?¥5 at the time of hospital admission and randomization. <br/ >2.Pregnant and / or lactating female patients. <br/ >3.A family history of congenital or hereditary immunodeficiency. <br/ >4.Any disease condition requiring ICU admission or which in the judgment of the Investigator would compromise the patientâ??s health. <br/ >5.History of dialysis, silicosis, solid organ transplantation such as renal or cardiac transplants, and disorders of the heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely that the patients will comply with the protocol as determined by the investigator. <br/ >6.History of administration of any immunoglobulins, any immunotherapy (antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use) and/or any blood products within the 3 months preceding study dosing, or planned future administrations during the study period. <br/ >7.History of allergic reactions or anaphylaxis to Mycobacterium w or its component. <br/ >8.Patients with generalized septic skin conditions. <br/ >9.Presence of any severe systemic/autoimmune disorders as determined by medical history and/or physical examination at the time of screening, which in the judgment of the Investigator would compromise the patientâ??s health or is likely to result in nonconformance to the protocol or a patientâ??s ability to give written informed consent. <br/ >

3

Cadila Pharmaceuticals

18

80

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

50

1.To compare the symptoms relief over the time among the three treatment group. <br/ >2.To compare the difference in proportion of patients with improved clinical outcome defined by ordinal scale over the time between the treatment groups. <br/ >3.To compare the duration for conversion of Covid-19 positive status to negative between the treatment groups. <br/ > <br/ >Timepoint: 1. Daily assessment of the patient. <br/ >2. At the end of 28 days or discharge of the patient- whichever is earlier.

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

Not reported

[{"arm_notes": "0.1ml;3;daily (3 days)", "treatment_id": 843, "treatment_name": "Mycobacterium indicus pranii", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "0.1ml;3;daily (one day)", "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"}]