Clinical trial NCT04358809: Clinical Trial of Mycobacterium w in COVID-19 Positive Patients, Hospitalized But Not Critically Ill
Official title: A Randomized, Double-blind, Two Arm, Controlled Clinical Trial to Compare the Efficacy and Safety of Mycobacterium w (Mw) Administered Along With Standard of Care Versus Placebo Administered Along With Standard of Care, in Adult, COVID 19 Positive Patients Hospitalized But Not Critically Ill.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: Cadila Pharnmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Council of Scientific and Industrial Research, India
First posted: 2020-04-24
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blinded, two arms, placebo controlled, clinical trial
Primary purpose: TREATMENT

Brief summary: This is a randomized, double blind, two arms, placebo controlled, clinical trial to study to evaluate the the safety and efficacy of Mycobacterium w in combination with standard of care versus placebo with standard of care for preventing the progression of COVID-19 disease and for reduction in transfer to ICU in COVID-19 infected patients admitted to the hospital.

Detailed description: Total 480 hospitalized adult eligible patients will be randomized in 1:1 ratio to receive either Mw+SOC or placebo+SOC for first 3 days post-randomization.

Daily clinical evaluation of patient will be performed till discharge from hospital or till ICU admission.

Study duration for each patient will be approximately up to 28 days, or discharge from hospital or transfer to ICU, whichever is earlier.

Eligibility criteria: Inclusion Criteria:

* COVID-19 positive patients with ordinal scale score of 3.
* Patients of either gender, age ≥ 18 years at the time of enrollment.
* 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.
* 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.

Exclusion Criteria:

* Patient with ordinal scale of ≥4 at the time of hospital admission and randomization.
* Pregnant and / or lactating female patients.
* A family history of congenital or hereditary immunodeficiency.
* Any disease condition requiring ICU admission.
* 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.
* 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.
* History of allergic reactions or anaphylaxis to Mw or its component.
* 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 patient's health or is likely to result nonconformance to the protocol or a patient's ability to give written informed consent.

Primary outcomes:
measure: Number of patients with increased disease severity
timeFrame: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
Secondary outcomes:
measure: Incidence of adverse events and serious adverse events (Safety)
timeFrame: Till day 28
measure: Number of COVID-19 patients discharged from hospital
timeFrame: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
measure: Number of COVID-19 patients transfer to ICU
timeFrame: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
measure: Number of COVID-19 patients with reduction in disease severity by 1 ordinal scale
timeFrame: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
measure: Number of of symptom free patients
timeFrame: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
Other outcomes:
Locations:
city: Raipur
country: India
facility: All India Institute of Medical Science, Raipur
state: Chhattisgarh
city: Bhopal
country: India
facility: All India Institute of Medical Sciences, Bhopal
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
city: Delhi
country: India
facility: All India Institute of Medical Sciences, Delhi
Study officials:
affiliation: Cadila Pharmaceuticals Limited
name: Sanjay Patel, MBBS
role: STUDY_CHAIR
References: