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COVID-19NCT04347174

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

A study testing Suspension of heat killed (autoclaved) Mycobacterium w in people with COVID-19, run by Cadila Pharnmaceuticals at 4 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
Suspension of heat killed (autoclaved) Mycobacterium w
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
4 sitesIndia
Study dates
30 Apr 2020to 21 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country.

India4 sites

  • All India Institute of Medical Sciences, Bhopal

    Bhopal, Madhya Pradesh, 462024

  • Postgraduate Institute of Medical Education and Research

    Chandigarh, 160012

  • All lndia Institute of Medical Science, Delhi

    Delhi, 110029

  • All India Institute of Medical Science, Raipur

    Raipur, Chhattisgarh, 492099

Other trials in India

About this study

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

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.

Read the 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.

Conditions
COVID-19
Being tested
Suspension of heat killed (autoclaved) Mycobacterium w, Placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Suspension of heat killed (autoclaved) Mycobacterium wDrug

    Also called Standard care of treatment for COVID-19 as per hospital practice

    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.

  • PlaceboDrug

    Also called Standard care of treatment for COVID-19 as per hospital practice

    All patients will continue to receive standard therapy as per hospital practice till considered requisite by the treating physician

Study groups in NCT04347174
Study groupRoleWhat they receive
Suspension of Mw + Standard therapy of COVID-19Experimental0.3 ml (0.1ml x 3 Injection) of intradermal Mw for 3 consecutive days + Standard therapy of COVID-19
Receives: Drug: Suspension of heat killed (autoclaved) Mycobacterium w
Standard therapy of COVID-19Placebo comparator0.3 ml (0.1ml x 3 Injection) of Placebo intra-dermal for 3 consecutive days
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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.

  2. 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

    Measured: 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 outcomes (8)

  1. Incidence of AE / SAE or event of clinical significance

    Any AE / SAE or event of clinical significance observed during the study.

    Measured: Till day 28

  2. SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample

    Percent of subjects with SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample.

    Measured: At days 3, 7, 14, 21, and 28

  3. ICU length of stay

    ICU length of stay

    Measured: Till day 28

  4. Duration of mechanical ventilation

    Duration of mechanical ventilation

    Measured: Till day 28

  5. Duration of hospitalization

    Duration of hospitalization

    Measured: Till day 28

  6. Clinical improvement

    Percentage of subjects having clinical improvement defined as two-point improvement on a seven category ordinal scale.

    Measured: From baseline to day 14 & Day 28

  7. Time (in days) from treatment initiation to death

    Time (in days) from treatment initiation to death.

    Measured: Till day 28

  8. All-cause mortality

    All-cause mortality

    Measured: Till day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2020
  2. Study start30 Apr 2020
  3. Primary completion10 Aug 2020
  4. Study completion21 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, blinded, two arms, active comparator controlled, clinical trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04347174
Sponsor's protocol ID
CRSC20004
Status last verified
Jan 2021
First submitted
31 Mar 2020
Last updated
27 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Suspension of heat killed (autoclaved) Mycobacterium w in people with COVID-19, run by Cadila Pharnmaceuticals at 4 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04347174.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.

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