Clinical Trial of Mycobacterium w in COVID-19 Positive Patients, Hospitalized But Not Critically Ill

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.

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.

Study Overview

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Drug: Suspension of heat killed (autoclaved) Mycobacterium w; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Anil Avhad, MBBS; Phone Number: 919833454044; Email: anil.avhad@cadilapharma.co.in
• Study Contact Backup: Name: Ashish Amarsheda; Phone Number: 919898073861; Email: ashish.a@cadilapharma.co.in

Study Locations

• India
  • Bhopal, India
    • Recruiting
    • All India Institute of Medical Sciences, Bhopal
    • Contact: Sarman Singh, MD; Phone Number: 917552672317; Email: director@aiimsbhopal.edu.in
    • Principal Investigator: Sarman Singh, MD
  • Chandigarh, India, 160012.
    • Recruiting
    • Post Graduate Institute of Medical Education and Research
    • Contact: Inderpaul Singh Sehgal, DM(Pulmonary Medicine); Phone Number: 01722756823; Email: inderpgi@outlook.com
    • Principal Investigator: Inderpaul Singh Sehgal, DM(Pulmonary Medicine)
  • Delhi, India, 110029
    • Recruiting
    • All India Institute of Medical Sciences, Delhi
    • Contact: Anant Mohan, MD; Phone Number: 911126588700; Email: anantmohan88@gmail.com
    • Principal Investigator: Anant Mohan, MD
  • Chhattisgarh
    • Raipur, Chhattisgarh, India, 492099
      • Recruiting
      • All India Institute of Medical Science, Raipur
      • Contact: Sajal De, MD; Phone Number: 917712577372; Email: sajalde@yahoo.com
      • Principal Investigator: Sajal De, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Suspension of Mw + Standard therapy of COVID-19; 0.3 ml (0.1ml x 3 Injection) of intradermal Mw for 3 consecutive days + Standard therapy of COVID-19	Drug: Suspension of heat killed (autoclaved) Mycobacterium w; Suspension of heat killed (autoclaved) Mw along with Standard of care (SOC) treatment for COVID-19
Placebo Comparator: Placebo; 0.3 ml (0.1ml x 3 Injection) of intradermal Placebo for 3 consecutive days + Standard therapy of COVID-19	Other: Placebo; Placebo along with Standard of care (SOC) treatment for COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with increased disease severity	To compare the difference in proportion of patients with increased disease severity	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events and serious adverse events (Safety)	To evaluate safety of Mw in COVID-19 patients admitted to hospital	Till day 28
Number of COVID-19 patients discharged from hospital	To compare the proportion of patients discharged from hospital	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.
Number of COVID-19 patients transfer to ICU	To compare the proportion of patients transfer to ICU	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.
Number of COVID-19 patients with reduction in disease severity by 1 ordinal scale	To compare the proportion of patients with reduction in disease severity by 1 ordinal scale	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.
Number of of symptom free patients	To compare the proportion of symptom free patients	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.

Collaborators and Investigators

• Sponsor: Cadila Pharnmaceuticals
• Collaborators: Council of Scientific and Industrial Research, India
• Investigators: Study Chair: Sanjay Patel, MBBS, Cadila Pharmaceuticals Limited

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Anticipated): February 28, 2021
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 20, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CRSC20006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No