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

Primary Purpose

COVID-19

Status

Unknown status

Phase

Phase 3

Locations

India

Study Type

Interventional

Intervention

Suspension of heat killed (autoclaved) Mycobacterium w

Placebo

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

All India Institute of Medical Science, RaipurRecruiting
All India Institute of Medical Sciences, BhopalRecruiting
Post Graduate Institute of Medical Education and ResearchRecruiting
All India Institute of Medical Sciences, DelhiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Suspension of Mw + Standard therapy of COVID-19

Placebo

Arm Description

0.3 ml (0.1ml x 3 Injection) of intradermal Mw for 3 consecutive days + Standard therapy of COVID-19

0.3 ml (0.1ml x 3 Injection) of intradermal Placebo for 3 consecutive days + Standard therapy of COVID-19

Outcomes

Primary Outcome Measures

Number of patients with increased disease severity

To compare the difference in proportion of patients with increased disease severity

Secondary Outcome Measures

Incidence of adverse events and serious adverse events (Safety)

To evaluate safety of Mw in COVID-19 patients admitted to hospital

Number of COVID-19 patients discharged from hospital

To compare the proportion of patients discharged from hospital

Number of COVID-19 patients transfer to ICU

To compare the proportion of patients transfer to ICU

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

Number of of symptom free patients

To compare the proportion of symptom free patients

Full Information

NCT ID

NCT04358809

First Posted

April 21, 2020

Last Updated

December 20, 2020

Sponsor

Cadila Pharnmaceuticals

Collaborators

Council of Scientific and Industrial Research, India

1. Study Identification

Unique Protocol Identification Number

NCT04358809

Brief Title

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

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 30, 2020 (Actual)

Primary Completion Date

February 28, 2021 (Anticipated)

Study Completion Date

April 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cadila Pharnmaceuticals

Collaborators

Council of Scientific and Industrial Research, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

A randomized, double-blinded, two arms, placebo controlled, clinical trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Suspension of Mw + Standard therapy of COVID-19

Arm Type

Experimental

Arm Description

0.3 ml (0.1ml x 3 Injection) of intradermal Mw for 3 consecutive days + Standard therapy of COVID-19

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

0.3 ml (0.1ml x 3 Injection) of intradermal Placebo for 3 consecutive days + Standard therapy of COVID-19

Intervention Type

Drug

Intervention Name(s)

Suspension of heat killed (autoclaved) Mycobacterium w

Intervention Description

Suspension of heat killed (autoclaved) Mw along with Standard of care (SOC) treatment for COVID-19

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo along with Standard of care (SOC) treatment for COVID-19

Primary Outcome Measure Information:

Title

Number of patients with increased disease severity

Description

To compare the difference in proportion of patients with increased disease severity

Time Frame

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 Measure Information:

Title

Incidence of adverse events and serious adverse events (Safety)

Description

To evaluate safety of Mw in COVID-19 patients admitted to hospital

Time Frame

Till day 28

Title

Number of COVID-19 patients discharged from hospital

Description

To compare the proportion of patients discharged from hospital

Time Frame

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.

Title

Number of COVID-19 patients transfer to ICU

Description

To compare the proportion of patients transfer to ICU

Time Frame

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.

Title

Number of COVID-19 patients with reduction in disease severity by 1 ordinal scale

Description

To compare the proportion of patients with reduction in disease severity by 1 ordinal scale

Time Frame

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.

Title

Number of of symptom free patients

Description

To compare the proportion of symptom free patients

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anil Avhad, MBBS

Phone

919833454044

anil.avhad@cadilapharma.co.in

First Name & Middle Initial & Last Name or Official Title & Degree

Ashish Amarsheda

Phone

919898073861

ashish.a@cadilapharma.co.in

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sanjay Patel, MBBS

Organizational Affiliation

Cadila Pharmaceuticals Limited

Official's Role

Study Chair

Facility Information:

Facility Name

All India Institute of Medical Science, Raipur

City

Raipur

State/Province

Chhattisgarh

ZIP/Postal Code

492099

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sajal De, MD

Phone

917712577372

sajalde@yahoo.com

First Name & Middle Initial & Last Name & Degree

Sajal De, MD

Facility Name

All India Institute of Medical Sciences, Bhopal

City

Bhopal

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarman Singh, MD

Phone

917552672317

director@aiimsbhopal.edu.in

First Name & Middle Initial & Last Name & Degree

Sarman Singh, MD

Facility Name

Post Graduate Institute of Medical Education and Research

City

Chandigarh

ZIP/Postal Code

160012.

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Inderpaul Singh Sehgal, DM(Pulmonary Medicine)

Phone

01722756823

inderpgi@outlook.com

First Name & Middle Initial & Last Name & Degree

Inderpaul Singh Sehgal, DM(Pulmonary Medicine)

Facility Name

All India Institute of Medical Sciences, Delhi

City

Delhi

ZIP/Postal Code

110029

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anant Mohan, MD

Phone

911126588700

anantmohan88@gmail.com

First Name & Middle Initial & Last Name & Degree

Anant Mohan, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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