Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial of Mycobacterium w in COVID-19 Positive Patients, Hospitalized But Not Critically Ill

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: NCT04358809
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Council of Scientific and Industrial Research, India
Information provided by (Responsible Party):
Cadila Pharnmaceuticals

Brief Summary:
This is a randomized, double blind, two arms, placebo controlled, clinical trial to study to evaluate the the safety and efficacy of Mycobacterium w in combination with standard of care versus placebo with standard of care for preventing the progression of COVID-19 disease and for reduction in transfer to ICU in COVID-19 infected patients admitted to the hospital.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Suspension of heat killed (autoclaved) Mycobacterium w Other: Placebo Phase 3

Detailed Description:

Total 480 hospitalized adult eligible patients will be randomized in 1:1 ratio to receive either Mw+SOC or placebo+SOC for first 3 days post-randomization.

Daily clinical evaluation of patient will be performed till discharge from hospital or till ICU admission.

Study duration for each patient will be approximately up to 28 days, or discharge from hospital or transfer to ICU, whichever is earlier.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, double-blinded, two arms, placebo controlled, clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Two Arm, Controlled Clinical Trial to Compare the Efficacy and Safety of Mycobacterium w (Mw) Administered Along With Standard of Care Versus Placebo Administered Along With Standard of Care, in Adult, COVID 19 Positive Patients Hospitalized But Not Critically Ill.
Estimated Study Start Date : April 30, 2020
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : April 30, 2021

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
Suspension of heat killed (autoclaved) Mw along with Standard of care (SOC) treatment for COVID-19

Placebo Comparator: Placebo
0.3 ml (0.1ml x 3 Injection) of intradermal Placebo for 3 consecutive days + Standard therapy of COVID-19
Other: Placebo
Placebo along with Standard of care (SOC) treatment for COVID-19




Primary Outcome Measures :
  1. Number of patients with increased disease severity [ Time Frame: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing. ]
    To compare the difference in proportion of patients with increased disease severity


Secondary Outcome Measures :
  1. Incidence of adverse events and serious adverse events (Safety) [ Time Frame: Till day 28 ]
    To evaluate safety of Mw in COVID-19 patients admitted to hospital

  2. Number of COVID-19 patients discharged from hospital [ Time Frame: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing. ]
    To compare the proportion of patients discharged from hospital

  3. Number of COVID-19 patients transfer to ICU [ Time Frame: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing. ]
    To compare the proportion of patients transfer to ICU

  4. Number of COVID-19 patients with reduction in disease severity by 1 ordinal scale [ Time Frame: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing. ]
    To compare the proportion of patients with reduction in disease severity by 1 ordinal scale

  5. Number of of symptom free patients [ Time Frame: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing. ]
    To compare the proportion of symptom free patients



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COVID-19 positive patients with ordinal scale score of 3.
  • Patients of either gender, age ≥ 18 years at the time of enrollment.
  • Female patients who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least 3 months post-dosing.
  • The patients must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form.

Exclusion Criteria:

  • Patient with ordinal scale of ≥4 at the time of hospital admission and randomization.
  • Pregnant and / or lactating female patients.
  • A family history of congenital or hereditary immunodeficiency.
  • Any disease condition requiring ICU admission.
  • History of dialysis, silicosis, solid organ transplantation such as renal or cardiac transplants, and disorders of the heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely that the patients will comply with the protocol as determined by the investigator.
  • History of administration of any immunoglobulins, any immunotherapy (antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use) and/or any blood products within the 3 months preceding study dosing, or planned future administrations during the study period.
  • History of allergic reactions or anaphylaxis to Mw or its component.
  • Presence of any severe systemic/autoimmune disorders as determined by medical history and/or physical examination at the time of screening, which in the judgment of the Investigator would compromise the patient's health or is likely to result nonconformance to the protocol or a patient's ability to give written informed consent.

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): NCT04358809


Contacts
Layout table for location contacts
Contact: Anil Avhad, MBBS 919833454044 anil.avhad@cadilapharma.co.in
Contact: Sanjay Patel, MBBS +912714221481 ext 270 sanjay.p@cadilapharma.co.in

Sponsors and Collaborators
Cadila Pharnmaceuticals
Council of Scientific and Industrial Research, India
Layout table for additonal information
Responsible Party: Cadila Pharnmaceuticals
ClinicalTrials.gov Identifier: NCT04358809    
Other Study ID Numbers: CRSC20006
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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