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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04347174
• Other study ID #: CRSC20004
• Status: Completed
• Phase: N/A
• Start date: April 30, 2020
• Est. completion date: August 21, 2020

Study information

• Verified date: January 2021
• Source: Cadila Pharnmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 21, 2020
• Est. primary completion date: August 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Critical Illness
• Mycobacterium Infections

Intervention

Drug:
• Suspension of heat killed (autoclaved) Mycobacterium w
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.
• Placebo
All patients will continue to receive standard therapy as per hospital practice till considered requisite by the treating physician

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences, Bhopal	Bhopal	Madhya Pradesh
India	Postgraduate Institute of Medical Education and Research	Chandigarh
India	All lndia Institute of Medical Science, Delhi	Delhi
India	All India Institute of Medical Science, Raipur	Raipur	Chhattisgarh

Sponsors (2)

Lead Sponsor	Collaborator
Cadila Pharnmaceuticals	Council of Scientific and Industrial Research, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Primary	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	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	Incidence of AE / SAE or event of clinical significance	Any AE / SAE or event of clinical significance observed during the study.	Till day 28
Secondary	SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample	Percent of subjects with SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample.	At days 3, 7, 14, 21, and 28
Secondary	ICU length of stay	ICU length of stay	Till day 28
Secondary	Duration of mechanical ventilation	Duration of mechanical ventilation	Till day 28
Secondary	Duration of hospitalization	Duration of hospitalization	Till day 28
Secondary	Clinical improvement	Percentage of subjects having clinical improvement defined as two-point improvement on a seven category ordinal scale.	From baseline to day 14 & Day 28
Secondary	Time (in days) from treatment initiation to death	Time (in days) from treatment initiation to death.	Till day 28
Secondary	All-cause mortality	All-cause mortality	Till day 28