Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04347174
Recruitment Status : Completed
First Posted : April 15, 2020
Last Update Posted : January 27, 2021
Sponsor:
Collaborator:
Council of Scientific and Industrial Research, India
Information provided by (Responsible Party):
Cadila Pharnmaceuticals

Tracking Information
First Submitted Date  ICMJE March 31, 2020
First Posted Date  ICMJE April 15, 2020
Last Update Posted Date January 27, 2021
Actual Study Start Date  ICMJE April 30, 2020
Actual Primary Completion Date August 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2021)
  • 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death) [ 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. ]
    To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
  • Sequential Organ Failure Assessment (SOFA) scores [ 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. ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2020)
  • SOFA scores [ Time Frame: Change in SOFA score from baseline to day 3 ]
    To study the effect of Mw on recovery of organ function as assessed by SOFA scores
  • SOFA scores [ Time Frame: Change in SOFA score from baseline to day 7 ]
    To study the effect of Mw on recovery of organ function as assessed by SOFA scores
  • SOFA scores [ Time Frame: Change in SOFA score from baseline to day 14 ]
    To study the effect of Mw on recovery of organ function as assessed by SOFA scores
  • SOFA scores [ Time Frame: Change in SOFA score from baseline to day 21 ]
    To study the effect of Mw on recovery of organ function as assessed by SOFA scores
  • SOFA scores [ Time Frame: Change in SOFA score from baseline to day 28 ]
    To study the effect of Mw on recovery of organ function as assessed by SOFA scores
  • SOFA scores [ Time Frame: Change in SOFA score from baseline to day of transfer from ICU, if earlier than 28 days. ]
    To study the effect of Mw on recovery of organ function as assessed by SOFA scores
  • Ordinal scale [ Time Frame: Change in Ordinal scale from baseline to day 3 ]
    To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
  • Ordinal scale [ Time Frame: Change in Ordinal scale from baseline to day 7 ]
    To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
  • Ordinal scale [ Time Frame: Change in Ordinal scale from baseline to day 14 ]
    To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
  • Ordinal scale [ Time Frame: Change in Ordinal scale from baseline to day 21 ]
    To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
  • Ordinal scale [ Time Frame: Change in Ordinal scale from baseline to day 28 ]
    To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
  • Ordinal scale [ Time Frame: Change in Ordinal scale from baseline to day of transfer from ICU, if earlier than 28 days. ]
    To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2021)
  • Incidence of AE / SAE or event of clinical significance [ Time Frame: Till day 28 ]
    Any AE / SAE or event of clinical significance observed during the study.
  • SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample [ Time Frame: At days 3, 7, 14, 21, and 28 ]
    Percent of subjects with SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample.
  • ICU length of stay [ Time Frame: Till day 28 ]
    ICU length of stay
  • Duration of mechanical ventilation [ Time Frame: Till day 28 ]
    Duration of mechanical ventilation
  • Duration of hospitalization [ Time Frame: Till day 28 ]
    Duration of hospitalization
  • Clinical improvement [ Time Frame: From baseline to day 14 & Day 28 ]
    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 Frame: Till day 28 ]
    Time (in days) from treatment initiation to death.
  • All-cause mortality [ Time Frame: Till day 28 ]
    All-cause mortality
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2020)
  • All-cause mortality [ Time Frame: Till day 28 ]
    All-cause mortality
  • Incidence of AE / SAE or event of clinical significance [ Time Frame: Till day 28 ]
    Any AE / SAE or event of clinical significance observed during the study.
  • SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample [ Time Frame: At days 3, 7, 14, 21, and 28 ]
    Percent of subjects with SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample.
  • ICU length of stay [ Time Frame: Till day 28 ]
    ICU length of stay
  • Duration of mechanical ventilation [ Time Frame: Till day 28 ]
    Duration of mechanical ventilation
  • Duration of hospitalization [ Time Frame: Till day 28 ]
    Duration of hospitalization
  • Clinical improvement [ Time Frame: From base line at day 14 & Day 28 ]
    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 Frame: Till day 28 ]
    Time (in days) from treatment initiation to death.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 Patients
Official Title  ICMJE A Clinical Trial to Evaluate the Safety and Efficacy of Mycobacterium W in Critically Ill Patients Suffering From COVID 19 Infection
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, blinded, two arms, active comparator controlled, clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Investigator, patient and study staff will be blinded to the study treatment.
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • 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.
    Other Name: Standard care of treatment for COVID-19 as per hospital practice
  • Drug: Placebo
    All patients will continue to receive standard therapy as per hospital practice till considered requisite by the treating physician
    Other Name: Standard care of treatment for COVID-19 as per hospital practice
Study Arms  ICMJE
  • 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

    Intervention: Drug: Suspension of heat killed (autoclaved) Mycobacterium w
  • Placebo Comparator: Standard therapy of COVID-19
    0.3 ml (0.1ml x 3 Injection) of Placebo intra-dermal for 3 consecutive days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 21, 2020
Actual Primary Completion Date August 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04347174
Other Study ID Numbers  ICMJE CRSC20004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cadila Pharnmaceuticals
Study Sponsor  ICMJE Cadila Pharnmaceuticals
Collaborators  ICMJE Council of Scientific and Industrial Research, India
Investigators  ICMJE
Study Chair: Anil Avhad, MBBS Cadila Pharmaceuticals Limited
PRS Account Cadila Pharnmaceuticals
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP