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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04347174
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : May 12, 2020
Sponsor:
Collaborator:
Council of Scientific and Industrial Research, India
Information provided by (Responsible Party):
Cadila Pharnmaceuticals

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Suspension of heat killed (autoclaved) Mycobacterium w Drug: Standard therapy of COVID-19 Not Applicable

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 water for injection (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 water for injection, intradermal, for 3 consecutive days.

Study duration for each patient will be 28 days.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Official Title: A Clinical Trial to Evaluate the Safety and Efficacy of Mycobacterium W in Critically Ill Patients Suffering From COVID 19 Infection
Actual Study Start Date : April 30, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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

Active Comparator: Standard therapy of COVID-19
0.3 ml (0.1ml x 3 Injection) of water for injection intra-dermal for 3 consecutive days
Drug: Standard therapy of COVID-19
All patients will continue to receive standard therapy as per hospital practice till considered requisite by the treating physician




Primary Outcome Measures :
  1. Sequential Organ Failure Assessment (SOFA) scores [ Time Frame: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 3 ]
    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

  2. Sequential Organ Failure Assessment (SOFA) scores [ Time Frame: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 7 ]
    To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) scores 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

  3. Sequential Organ Failure Assessment (SOFA) scores [ Time Frame: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 14 ]
    To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) scores 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

  4. Sequential Organ Failure Assessment (SOFA) scores [ Time Frame: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 21 ]
    To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) scores 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

  5. Sequential Organ Failure Assessment (SOFA) scores [ Time Frame: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 28 ]
    To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) scores 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

  6. Sequential Organ Failure Assessment (SOFA) scores [ Time Frame: Change in Sequential Organ Failure Assessment (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 Sequential Organ Failure Assessment (SOFA) scores 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

  7. 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 ]
    To study the effect of Mw on recovery of organ function as assessed by Ordinal scale

  8. 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 7 ]
    To study the effect of Mw on recovery of organ function as assessed by Ordinal scale

  9. 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 14 ]
    To study the effect of Mw on recovery of organ function as assessed by Ordinal scale

  10. 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 21 ]
    To study the effect of Mw on recovery of organ function as assessed by Ordinal scale

  11. 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 28 ]
    To study the effect of Mw on recovery of organ function as assessed by Ordinal scale

  12. 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 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


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: Till day 28 ]
    All-cause mortality

  2. 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.

  3. 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.

  4. ICU length of stay [ Time Frame: Till day 28 ]
    ICU length of stay

  5. Duration of mechanical ventilation [ Time Frame: Till day 28 ]
    Duration of mechanical ventilation

  6. Duration of hospitalization [ Time Frame: Till day 28 ]
    Duration of hospitalization

  7. 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.

  8. Time (in days) from treatment initiation to death [ Time Frame: Till day 28 ]
    Time (in days) from treatment initiation to death.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04347174


Contacts
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Contact: Sanjay Patel, MBBS +912714221481 ext 270 sanjay.p@cadilapharma.co.in
Contact: Ashish Amarsheda, M.Pharm. +919898073861 ashish.a@cadilapharma.co.in

Locations
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India
All India Institute of Medical Sciences, Bhopal Recruiting
Bhopal, Madhya Pradesh, India, 462024
Contact: Sarman Singh, MD (Medical Microbiology)    917552672317    director@aiimsbhopal.edu.in   
Postgraduate Institute of Medical Education and Research Not yet recruiting
Chandigarh, India, 160012
Contact: Inderpaul Singh Sehgal, MD, DM (Pulmonary Medicine)    9101722748215    inderpgi@outlook.com   
Sponsors and Collaborators
Cadila Pharnmaceuticals
Council of Scientific and Industrial Research, India
Investigators
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Study Chair: Anil Avhad, MBBS Cadila Pharmaceuticals Limited
Study Chair: Nomita Bhandari, MD Cadila Pharmaceuticals Limited
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Responsible Party: Cadila Pharnmaceuticals
ClinicalTrials.gov Identifier: NCT04347174    
Other Study ID Numbers: CRSC20004
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mycobacterium Infections
Critical Illness
Disease Attributes
Pathologic Processes
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections