COVID-19Phase 3NCT04353518
Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19
A Phase 3 study testing Suspension of heat killed (autoclaved) Mycobacterium w in people with COVID-19, run by Cadila Pharnmaceuticals at 3 sites in India.
Trial summary
This clinical trial is a randomized, blinded, two arms, placebo controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice to prevent COVID 19 in subjects at risk of getting infected with COVID 19. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- 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
- 4,000 participants
- Where
- 3 sitesIndia
- Study dates
- 30 Jun 2020to 30 May 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects of either gender, age ≥ 18 years, with recent history of close contact with COVID-19 patients.
- Subjects with SARS Cov 2 negative test (ICMR approved test kit) at screening visit.
- Female subject 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 months post-dosing.
- The subject 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
- Any febrile illness with oral temperature > 100°F within 3 days prior to randomization.
- Subject with past history of COVID-19 infection.
- Pregnant and / or lactating female subjects.
- Presence of any illness requiring hospital referral.
- Any confirmed or suspected immune-deficient condition based on medical history and physical examination and a family history of congenital or hereditary immunodeficiency or Individuals on immunosuppressant's as Azathioprine, Cyclosporine, Mycophenolate etc.
- History of allergic reactions or anaphylaxis to Mw or its component.
Trial locations and contacts
3 sites in 1 country.
India3 sites, 3 recruiting
- Recruiting
All India Institute of Medical Sciences, Bhopal
Bhopal, Madhya Pradesh, 462024
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 lndia Institute of Medical Science, Delhi
Delhi, 110029
Sushma Bhatnagar, MD (Anaesthesiology), 919811326453, sushmabhatnagar1@gmail.com
Sushma Bhatnagar, MD (Anaesthesiology)
About this study
Official title: A Randomized, Double-blind, Two Arm, Placebo Controlled Clinical Trial to Evaluate the Efficacy and Safety of Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19.
This clinical trial is a randomized, blinded, two arms, placebo controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice to prevent COVID 19 in subjects at risk of getting infected with COVID 19.
Read the detailed description
Approximately eligible 4000 subjects who are at risk of getting infected with COVID-19 (i.e. person living in same household as COVID-19 patients / healthcare workers providing direct care to COVID-19 patients) will be enrolled in to the study after due consent and based on the eligibility criteria.
Initially, 400 subjects at risk of getting infected with COVID-19 will be enrolled in the study and randomized in 1:1 ratio to receive either Mw (n=200) or placebo (n=200). After the interim analysis from the data of these 400 subjects for safety and efficacy and based on review and recommendations from DSMB / MC, modification in study design, objective or sample size will be considered.
Study duration for each subject will be of 8 weeks.
- 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
Subjects randomized to Test arm will receive intraderma Mw in divided doses at least 2 cm away from first injection site in the deltoid region.
PlaceboOther
Subjects randomized to placebo arm will receive intraderma Placebo in divided doses at least 2 cm away from first injection site in the deltoid region.
| Study group | Role | What they receive |
|---|---|---|
| Suspension of Mw | Experimental | Intradermal suspension of Mw will be administered in two divided doses:
Dose 1 at Day 0: 0.2 ml (0.1 ml x 2 injection) of intradermal Mw in two divided dose.
Dose 2 at Day 15 after the first dose: 0.1 ml injection of intradermal Mw administered. Receives: Drug: Suspension of heat killed (autoclaved) Mycobacterium w |
| Placebo | Placebo comparator | Placebo will be administered in two divided doses:
Dose 1 at Day 0: 0.2 ml (0.1 ml x 2 injection) of intradermal placebo in two divided dose.
Dose 2 at Day 15 after the first dose: 0.1 ml injection of intradermal placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subject acquiring COVID-19 infection
To compare proportion of subjects acquiring COVID-19 infection between two arms over the time till 8 weeks from administration of 1st dose
Measured: From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing..
Secondary outcomes (3)
Incidence of Adverse Event and Serious Adverse Event (safety and tolerability)
Any AE / SAE observed during the study.
Measured: Till 8 weeks
Number of subject developing Upper Respiratory Tract Infection (URTI) symptoms
Whether administration of Mw prevents development of Upper Respiratory Tract Infection (URTI) symptoms in close contacts of COVID-19 patients.
Measured: From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing.
Number of subject developing severe COVID-19 infection based on ordinal scale
Whether administration of Mw prevents development of severe COVID-19 infection.
Measured: From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week 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 posted20 Apr 2020
- Study start30 Jun 2020
- Primary completion30 Mar 2021 (estimated)
- Study completion30 May 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, two arms, placebo controlled, clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,000 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
- Anil Avhad, MBBS, Study chair, Cadila Pharmaceuticals Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353518
- Sponsor's protocol ID
- CRSC20005
- Status last verified
- Apr 2020
- First submitted
- 16 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, Placebo Controlled Clinical Trial to Evaluate the Efficacy and Safety of Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19.
- ClinicalTrials.gov ID
- NCT04353518
- Acronym / sponsor ID
- CRSC20005
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 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
- 30 Mar 2021 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 20 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 clinical trial is a randomized, blinded, two arms, placebo controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice to prevent COVID 19 in subjects at risk of getting infected with COVID 19.
Detailed description
Approximately eligible 4000 subjects who are at risk of getting infected with COVID-19 (i.e. person living in same household as COVID-19 patients / healthcare workers providing direct care to COVID-19 patients) will be enrolled in to the study after due consent and based on the eligibility criteria.
Initially, 400 subjects at risk of getting infected with COVID-19 will be enrolled in the study and randomized in 1:1 ratio to receive either Mw (n=200) or placebo (n=200). After the interim analysis from the data of these 400 subjects for safety and efficacy and based on review and recommendations from DSMB / MC, modification in study design, objective or sample size will be considered.
Study duration for each subject will be of 8 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, two arms, placebo controlled, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Suspension of Mw | Experimental | Drug: Suspension of heat killed (autoclaved) Mycobacterium wIntradermal suspension of Mw will be administered in two divided doses: Dose 1 at Day 0: 0.2 ml (0.1 ml x 2 injection) of intradermal Mw in two divided dose. Dose 2 at Day 15 after the first dose: 0.1 ml injection of intradermal Mw administered. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo will be administered in two divided doses: Dose 1 at Day 0: 0.2 ml (0.1 ml x 2 injection) of intradermal placebo in two divided dose. Dose 2 at Day 15 after the first dose: 0.1 ml injection of intradermal placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy subjects of either gender, age ≥ 18 years, with recent history of close contact with COVID-19 patients.
- Subjects with SARS Cov 2 negative test (ICMR approved test kit) at screening visit.
- Female subject 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 months post-dosing.
- The subject 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 (6 listed)
- Any febrile illness with oral temperature > 100°F within 3 days prior to randomization.
- Subject with past history of COVID-19 infection.
- Pregnant and / or lactating female subjects.
- Presence of any illness requiring hospital referral.
- Any confirmed or suspected immune-deficient condition based on medical history and physical examination and a family history of congenital or hereditary immunodeficiency or Individuals on immunosuppressant's as Azathioprine, Cyclosporine, Mycophenolate etc.
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 wSubjects randomized to Test arm will receive intraderma Mw in divided doses at least 2 cm away from first injection site in the deltoid region. | Drug | Suspension of Mw |
| PlaceboSubjects randomized to placebo arm will receive intraderma Placebo in divided doses at least 2 cm away from first injection site in the deltoid region. | Other | Placebo |
Primary outcome
Number of subject acquiring COVID-19 infection
Time frame: From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing..
To compare proportion of subjects acquiring COVID-19 infection between two arms over the time till 8 weeks from administration of 1st dose
3 secondary outcomes
Incidence of Adverse Event and Serious Adverse Event (safety and tolerability)
Time frame: Till 8 weeks
Number of subject developing Upper Respiratory Tract Infection (URTI) symptoms
Time frame: From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing.
Number of subject developing severe COVID-19 infection based on ordinal scale
Time frame: From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week 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.
Anil Avhad, MBBS study chair
Cadila Pharmaceuticals Limited
3 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 3 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 6 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 3 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 Sanjay Patel, MBBS (+912714221481 ext. 270, sanjay.p@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 subject acquiring COVID-19 infection (time frame: From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week 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.