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.
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
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 group | Role | What they receive |
|---|---|---|
| Suspension of Mw + Standard therapy of COVID-19 | Experimental | 0.3 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-19 | Placebo comparator | 0.3 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.
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.
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)
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
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
ICU length of stay
ICU length of stay
Measured: Till day 28
Duration of mechanical ventilation
Duration of mechanical ventilation
Measured: Till day 28
Duration of hospitalization
Duration of hospitalization
Measured: Till day 28
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
Time (in days) from treatment initiation to death
Time (in days) from treatment initiation to death.
Measured: Till day 28
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.
- First posted15 Apr 2020
- Study start30 Apr 2020
- Primary completion10 Aug 2020
- Study completion21 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cadila Pharnmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Council of Scientific and Industrial Research, India
- Responsible party
- Sponsor
- Investigators
- Anil Avhad, MBBS, Study chair, Cadila Pharmaceuticals Limited
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Safety and Efficacy of Mycobacterium W in Critically Ill Patients Suffering From COVID 19 Infection
- ClinicalTrials.gov ID
- NCT04347174
- Acronym / sponsor ID
- CRSC20004
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cadila PharnmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Council of Scientific and Industrial Research, India
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 10 Aug 2020 (actual)
- Study completion
- 21 Aug 2020 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, blinded, two arms, active comparator controlled, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Suspension of Mw + Standard therapy of COVID-19 | Experimental | Drug: Suspension of heat killed (autoclaved) Mycobacterium w0.3 ml (0.1ml x 3 Injection) of intradermal Mw for 3 consecutive days + Standard therapy of COVID-19 |
| Standard therapy of COVID-19 | Placebo comparator | Drug: Placebo0.3 ml (0.1ml x 3 Injection) of Placebo intra-dermal for 3 consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suspension of heat killed (autoclaved) Mycobacterium wAlso: Standard care of treatment for COVID-19 as per hospital practicePatients 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. | Drug | Suspension of Mw + Standard therapy of COVID-19 |
| PlaceboAlso: Standard care of treatment for COVID-19 as per hospital practiceAll patients will continue to receive standard therapy as per hospital practice till considered requisite by the treating physician | Drug | Standard therapy of COVID-19 |
Primary outcome
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
8 secondary outcomes
Incidence of AE / SAE or event of clinical significance
Time frame: Till day 28
SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample
Time frame: At days 3, 7, 14, 21, and 28
ICU length of stay
Time frame: Till day 28
Duration of mechanical ventilation
Time frame: Till day 28
Duration of hospitalization
Time frame: Till day 28
Clinical improvement
Time frame: From baseline to day 14 & Day 28
Time (in days) from treatment initiation to death
Time frame: Till day 28
All-cause mortality
Time frame: Till day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anil Avhad, MBBS study chair
Cadila Pharmaceuticals Limited
4 sites in 1 country: see every site and its status.
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?
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; AzTrials last refreshed its copy on 8 Nov 2026.