COVID-19Phase 3NCT04358809
Clinical Trial of Mycobacterium w in COVID-19 Positive Patients, Hospitalized But Not Critically Ill
A Phase 3 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
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… 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
- 480 participants
- Where
- 4 sitesIndia
- Study dates
- 30 Jun 2020to 30 Apr 2021
- Phase
- Phase 3
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
India4 sites, 4 recruiting
- Recruiting
All India Institute of Medical Sciences, Bhopal
Bhopal
Sarman Singh, MD, 917552672317, director@aiimsbhopal.edu.in
Sarman Singh, MD
- Recruiting
Post Graduate Institute of Medical Education and Research
Chandigarh, 160012.
Inderpaul Singh Sehgal, DM(Pulmonary Medicine), 01722756823, inderpgi@outlook.com
Inderpaul Singh Sehgal, DM(Pulmonary Medicine)
- Recruiting
All India Institute of Medical Sciences, Delhi
Delhi, 110029
Anant Mohan, MD, 911126588700, anantmohan88@gmail.com
Anant Mohan, MD
- Recruiting
All India Institute of Medical Science, Raipur
Raipur, Chhattisgarh, 492099
Sajal De, MD, 917712577372, sajalde@yahoo.com
Sajal De, MD
About this study
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.
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.
Read the 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.
- 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
Suspension of heat killed (autoclaved) Mw along with Standard of care (SOC) treatment for COVID-19
PlaceboOther
Placebo along with Standard of care (SOC) treatment for COVID-19
| 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 |
| Placebo | Placebo comparator | 0.3 ml (0.1ml x 3 Injection) of intradermal Placebo for 3 consecutive days + Standard therapy of COVID-19 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with increased disease severity
To compare the difference in proportion of patients with increased disease severity
Measured: 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.
Secondary outcomes (5)
Incidence of adverse events and serious adverse events (Safety)
To evaluate safety of Mw in COVID-19 patients admitted to hospital
Measured: Till day 28
Number of COVID-19 patients discharged from hospital
To compare the proportion of patients discharged from hospital
Measured: 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.
Number of COVID-19 patients transfer to ICU
To compare the proportion of patients transfer to ICU
Measured: 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.
Number of COVID-19 patients with reduction in disease severity by 1 ordinal scale
To compare the proportion of patients with reduction in disease severity by 1 ordinal scale
Measured: 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.
Number of of symptom free patients
To compare the proportion of symptom free patients
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start30 Jun 2020
- Primary completion28 Feb 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blinded, two arms, placebo controlled, clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
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
- Sanjay Patel, MBBS, Study chair, Cadila Pharmaceuticals Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358809
- Sponsor's protocol ID
- CRSC20006
- Status last verified
- Dec 2020
- First submitted
- 21 Apr 2020
- Last updated
- 22 Dec 2020
- 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 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04358809
- Acronym / sponsor ID
- CRSC20006
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Cadila PharnmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Council of Scientific and Industrial Research, India
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 24 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.
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.
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.
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
- A randomized, double-blinded, two arms, placebo 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 |
| Placebo | Placebo comparator | Other: Placebo0.3 ml (0.1ml x 3 Injection) of intradermal Placebo for 3 consecutive days + Standard therapy of COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 wSuspension of heat killed (autoclaved) Mw along with Standard of care (SOC) treatment for COVID-19 | Drug | Suspension of Mw + Standard therapy of COVID-19 |
| PlaceboPlacebo along with Standard of care (SOC) treatment for COVID-19 | Other | Placebo |
Primary outcome
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
5 secondary outcomes
Incidence of adverse events and serious adverse events (Safety)
Time frame: Till day 28
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- 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.
Sanjay Patel, 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 Phase 3 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 Dec 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anil Avhad, MBBS (919833454044, anil.avhad@cadilapharma.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 22 Dec 2020.