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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04347174
Other study ID # CRSC20004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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