Back to results

A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 Patients

Primary Purpose

COVID-19

Status

Completed

Phase

Not Applicable

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:

Critically ill patients infected with COVID-19 (clinical/confirmed)
Patient aged 18 years or more of either gender
Illness of any duration with respiratory rate ≥25 breaths/minute, and at least one of the following:
- Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or or
- SpO2 ≤94% on room air, or
- Requiring mechanical ventilation and/or supplemental oxygen
Female patients of childbearing potential must have a negative pregnancy test within 14 days prior to first dose of study medication.
Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedure.

Exclusion Criteria:

Pregnant or nursing female.
Patients with history of allergy, hypersensitivity, or any serious reaction to study medication
Patients with a concomitant medical condition, whose participation, in the opinion of the investigator, may create an unacceptable additional risk.
Patient previously enrolled into this study.
Patient participating or having participated in a clinical trial with another investigational drug within the last 28 days except for investigational drugs against cancer, leukaemia or HIV.
Patients with a life expectancy judged to be less than five days
ALT/AST > 5 times the upper limit of normal
Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)
Patients not likely to complete the trial as per judgment of the investigator.

Sites / Locations

All India Institute of Medical Science, Raipur
All India Institute of Medical Sciences, Bhopal
Postgraduate Institute of Medical Education and Research
All lndia Institute of Medical Science, Delhi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Suspension of Mw + Standard therapy of COVID-19

Standard therapy of COVID-19

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 Placebo intra-dermal for 3 consecutive days

Outcomes

Primary Outcome Measures

7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death)

To study the effect of Mw on recovery of organ function as assessed by Ordinal scale

Sequential Organ Failure Assessment (SOFA) scores

To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction

Secondary Outcome Measures

Incidence of AE / SAE or event of clinical significance

Any AE / SAE or event of clinical significance observed during the study.

SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample

Percent of subjects with SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample.

ICU length of stay

Duration of mechanical ventilation

Duration of hospitalization

Clinical improvement

Percentage of subjects having clinical improvement defined as two-point improvement on a seven category ordinal scale.

Time (in days) from treatment initiation to death

Time (in days) from treatment initiation to death.

All-cause mortality

Full Information

NCT ID

NCT04347174

First Posted

March 31, 2020

Last Updated

January 25, 2021

Sponsor

Cadila Pharnmaceuticals

Collaborators

Council of Scientific and Industrial Research, India

1. Study Identification

Unique Protocol Identification Number

NCT04347174

Brief Title

A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 Patients

Official Title

A Clinical Trial to Evaluate the Safety and Efficacy of Mycobacterium W in Critically Ill Patients Suffering From COVID 19 Infection

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

April 30, 2020 (Actual)

Primary Completion Date

August 10, 2020 (Actual)

Study Completion Date

August 21, 2020 (Actual)

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

The trial is randomized, blinded, two arms, active comparator controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice versus standard care alone in critically ill adult patients suffering from COVID-19 infection.

Detailed Description

In this study, Eligible patients will be enrolled after due consent and will be randomized in balance to receive either test drug (along with the standard of care) or Placebo (along with the standard of care). The enrolled patients will be monitored for any adverse events (AEs) or serious adverse events (SAEs) throughout the study period. All patients will continue to receive standard therapy till considered requisite by the treating physician. In addition to the standard care for COVID-19, patients randomized to test arm will receive single daily dose of 0.3 ml of Mw, intradermal, for 3 consecutive days while patients randomized to control arm will receive single daily dose of 0.3 ml of Placebo, intradermal, for 3 consecutive days. Study duration for each patient will be upto 28 days post-randomization.

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

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized, blinded, two arms, active comparator controlled, clinical trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Investigator, patient and study staff will be blinded to the study treatment.

Allocation

Randomized

Enrollment

40 (Actual)

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

Standard therapy of COVID-19

Arm Type

Placebo Comparator

Arm Description

0.3 ml (0.1ml x 3 Injection) of Placebo intra-dermal for 3 consecutive days

Intervention Type

Drug

Intervention Name(s)

Suspension of heat killed (autoclaved) Mycobacterium w

Other Intervention Name(s)

Standard care of treatment for COVID-19 as per hospital practice

Intervention Description

Patients will be randomized to receive either Mycobacterium w in combination with standard care as per hospital practice or standard care alone in COVID-19 as per hospital practice.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Standard care of treatment for COVID-19 as per hospital practice

Intervention Description

All patients will continue to receive standard therapy as per hospital practice till considered requisite by the treating physician

Primary Outcome Measure Information:

Title

7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death)

Description

To study the effect of Mw on recovery of organ function as assessed by Ordinal scale

Time Frame

Change in Ordinal scale from baseline to day 3, day 7, day 14, day 21 and day 28 and day of transfer from ICU, if discharged earlier than 28 days post-randomization.

Title

Sequential Organ Failure Assessment (SOFA) scores

Description

Time Frame

Change in SOFA score from baseline to day 3, day 7, day 14, day 21 and day 28 and day of transfer from ICU, if discharged earlier than 28 days post-randomization.

Secondary Outcome Measure Information:

Title

Incidence of AE / SAE or event of clinical significance

Description

Any AE / SAE or event of clinical significance observed during the study.

Time Frame

Till day 28

Title

SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample

Description

Percent of subjects with SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample.

Time Frame

At days 3, 7, 14, 21, and 28

Title

ICU length of stay

Description

ICU length of stay

Time Frame

Till day 28

Title

Duration of mechanical ventilation

Description

Duration of mechanical ventilation

Time Frame

Till day 28

Title

Duration of hospitalization

Description

Duration of hospitalization

Time Frame

Till day 28

Title

Clinical improvement

Description

Percentage of subjects having clinical improvement defined as two-point improvement on a seven category ordinal scale.

Time Frame

From baseline to day 14 & Day 28

Title

Time (in days) from treatment initiation to death

Description

Time (in days) from treatment initiation to death.

Time Frame

Till day 28

Title

All-cause mortality

Description

All-cause mortality

Time Frame

Till day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Critically ill patients infected with COVID-19 (clinical/confirmed) Patient aged 18 years or more of either gender Illness of any duration with respiratory rate ≥25 breaths/minute, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or or SpO2 ≤94% on room air, or Requiring mechanical ventilation and/or supplemental oxygen Female patients of childbearing potential must have a negative pregnancy test within 14 days prior to first dose of study medication. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedure. Exclusion Criteria: Pregnant or nursing female. Patients with history of allergy, hypersensitivity, or any serious reaction to study medication Patients with a concomitant medical condition, whose participation, in the opinion of the investigator, may create an unacceptable additional risk. Patient previously enrolled into this study. Patient participating or having participated in a clinical trial with another investigational drug within the last 28 days except for investigational drugs against cancer, leukaemia or HIV. Patients with a life expectancy judged to be less than five days ALT/AST > 5 times the upper limit of normal Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30) Patients not likely to complete the trial as per judgment of the investigator.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anil Avhad, 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

Facility Name

All India Institute of Medical Sciences, Bhopal

City

Bhopal

State/Province

Madhya Pradesh

ZIP/Postal Code

462024

Country

India

Facility Name

Postgraduate Institute of Medical Education and Research

City

Chandigarh

ZIP/Postal Code

160012

Country

India

Facility Name

All lndia Institute of Medical Science, Delhi

City

Delhi

ZIP/Postal Code

110029

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 Patients

We'll reach out to this number within 24 hrs