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NCT04358809
Clinical Trial of Mycobacterium w in COVID-19 Positive Patients, Hospitalized But Not Critically Ill
Phase 3 trial testing Suspension of heat killed (autoclaved) Mycobacterium w in COVID-19 in 480 participants. Status unknown.
28 February 2021
Quick facts
| Lead sponsor | Cadila Pharnmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 480 |
| Start date | 30 June 2020 |
| Primary completion | 28 February 2021 |
| Estimated completion | 30 April 2021 |
| Sites | 4 locations across India |
Drugs / interventions tested
- Suspension of heat killed (autoclaved) Mycobacterium w — full drug profile →
- Placebo
Conditions studied
- COVID-19 — all drugs for COVID-19 →
Sponsor
Cadila Pharnmaceuticals — full company profile →
Who can join
18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Drug Repurposing for Prevention and Treatment of COVID-19: A Clinical Landscape.
Hossain MS, Hami I, Sawrav MSS, Rabbi MF, et al · · 2020 · cited 16× · PMID 33403227 · DOI 10.15190/d.2020.18 -
Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review.
Mathioudakis AG, Fally M, Hashad R, Kouta A, et al · · 2020 · cited 14× · PMID 33333777 · DOI 10.3390/life10120350 -
Impact of an Immune Modulator Mycobacterium-w on Adaptive Natural Killer Cells and Protection Against COVID-19.
Jaiswal SR, Arunachalam J, Saifullah A, Lakhchaura R, et al · · 2022 · cited 9× · PMID 35603154 · DOI 10.3389/fimmu.2022.887230 -
Will bacille Calmette-Guerin immunization arrest the COVID-19 pandemic?
Ehtesham NZ, Samal J, Ahmad F, Arish M, et al · · 2020 · cited 7× · PMID 32859863 · DOI 10.4103/ijmr.ijmr_1563_20
Verify or expand the search:
- PubMed search for NCT04358809
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Suspension of heat killed (autoclaved) Mycobacterium w
Trials testing the same drug.
- NCT04353518 — Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19 · Phase 3 · unknown
- NCT04347174 — A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 Patients · NA · completed
Other recruiting trials for COVID-19
Currently open trials in the same condition.
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- NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
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- NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
- NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting
Other Cadila Pharnmaceuticals trials
Trials by the same sponsor.
- NCT04353518 — Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19 · Phase 3 · unknown
- NCT04347174 — A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 Patients · NA · completed
- NCT04801199 — Effect of CPL-2009-0031 in the Treatment of Patients With Uncontrolled Type 2 Diabetes Mellitus · Phase 3 · completed
- NCT05174598 — A Clinical Trial to Evaluate Efficacy and Safety of Two Different Formulations of Topical Calcipotriol in Patients With · Phase 3 · completed
- NCT00694915 — Study of Mycobacterium w in Superficial Transitional Cell Carcinoma of Bladder · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04358809 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cadila Pharnmaceuticals
- Last refreshed: 22 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04358809.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing