On-going research at SRM Medical College Hospital
COVID- 19 Vaccine development at SRM Medical College Hospital
Recently Bharat Biotech India Limited (BBIL) launched the early clinical trials of COVAXIN in 12 hospitals across the country SRM Hospital is the only hospital that was chosen to conduct the early phase trials in Tamil Nadu.
- Early clinical trials (Phase 1 & Phase 2) were limited to healthy volunteers
- Above 75 volunteers participated in these trials and they are presently on follow-up
- We are now about to initiate Phase 3 clinical trials with volunteers of different health conditions including those at a high risk of mortality and multiple diseases
- Our able & dedicated team of younger physicians, anaesthetists, clinical research coordinators, nursing staff and other site personnel ensure that all trial activities are carried out as per the Governmental regulations.
COVID- 19 Research
SRM Medical College Hospital was one of the hospitals which offered care to more than 1500 patients with COVID-19 at various stages of illness including a ____ no of patients who recovered after treatment in the COVID ICU. The hospital has also been actively engaged in the research front during the pandemic. The prestigious COVAXIN clinical trial was conducted at SRM Hospital for all three phases of the trial. Around 700 participants were enrolled in this studies and were randomized. This study was sponsored by Bharat Biottech and ICMR. SRM was one of the few hospitals in South India and the only hospital in Tamil Nadu to carry out these trials. The site was primarily selected due to the vast experience of the investigators, study team and state of the art infrastructure available to carry out robust clinical trials.
Besides this, the hospital was involved in 2 major studies to evaluate the effectiveness of Siddha formulations including but not limited to Kabasura kudineer in patients with mild to moderate COVID-19. One of the studies was a retrospective study that was carried out to test the effectiveness of the siddha formulations on the basis of the data obtained from Medical Records dept. The second was a randomized controlled trial in which patients with mild to moderate COVID 19 were randomized to receive Siddha formulations or standard of care. Standard therapy was given to all patients in the study as a background therapy. More than 350 patients were enrolled in these studies. The effectiveness of hydroxychloroquine was studied as a prophylactic agent among health care workers for COVID 19. This was a multi centric cohort study initiated by ICMR Rational Use of Medicines Centres and carried out at more than 20 sites and SRM Hospital was one of the hospitals which carried out this research. Besides these, a number of other research projects have been carried out at SRM hospital by the post graduates who were posted in COVID ward. All of the above work is either published or in the process of undergoing peer review by journal reviewers.
Clinical Trials
S.No | Type of Clinical Trial ( Drug/vaccine) | Indication | Candidate | Sponsored /Academic | Phase of Trial | Year | Status |
---|---|---|---|---|---|---|---|
1 | Vaccine | Rotavirus | ROTAVAC | Bharat Biotech Ltd. | IV | 2014-15 | Completed |
2 | Vaccine | Rotavirus | ROTA5C | Bharat Biotech Ltd. | III | 2015-17 | Completed |
3 | Vaccine | Pentavalent vaccine | SHAN5 | Shanta Biotech, Hyderabad | III | 2015-16 | Completed |
4 | Vaccine | Rotavirus | ROTA5CM | Bharat Biotech Ltd. | III | 2017-18 | Completed |
5 | Vaccine | Quadrivalent vaccine | DTwP-Hib | Bharat Biotech Ltd. | III | 2017-18 | Completed |
6 | Vaccine | Pentavalent vaccine | DTwP-HepB-PRP-T | Shanta Biotechnics | III | 2018-21 | Completed |
7 | Vaccine | Meningococcal vaccine | MET55 | Sanofi | III | 2019-21 | Ongoing |
8 | Drug | Surgical Wound | Lysostaphin Gel | Bharat Biotech Ltd. | IIb/III | 2017-18 | Completed |
9 | Drug | Asthma | Salbutamol | Cliantha Research | BA/BE | 2019-20 | Completed |
10 | Vaccine | Covid | rBCG | SII, Pune | II | 2020-21 | Ongoing |
11 | Vaccine | Covid | BBV152, Inactivated SARS-Cov-2 Vaccine | Bharat Biotech Ltd. | I | 2020-21 | Ongoing |
12 | Vaccine | Covid | BBV152, Inactivated SARS-Cov-2 Vaccine | Bharat Biotech Ltd. | II | 2020-21 | Ongoing |
13 | Vaccine | Covid | BBV152, Inactivated SARS-Cov-2 Vaccine | Bharat Biotech Ltd. | III | 2020-22 | Ongoing |
14 | Vaccine | Covid | BBV152, Inactivated SARS-Cov-2 Vaccine-Booster Dose | Bharat Biotech Ltd. | III | 2021-22 | Ongoing |
15 | Vaccine | Covid | VAT00008/Monovalent/bivalent COVID vaccine | Sanofi-GSK | III | 2021-22 | Ongoing |
16 | Vaccine | Meningococcal vaccine | MEQ00064 | Sanofi | III | 2021- | Proposed |
17 | Drug | Covid | Aspirin-Colchicine | PHRI, Canada | III | 2021- | Ongoing |
18 | Monoclonal Antibody | Acute Coronary Syndrome | Alirocumab | ODYSSEY OUTCOMES trial, Sanofi | III | 2015-19 | Completed |
19 | Polycap formualtion | Primary prevention of CVD | Aspirin-Vit D | TIPS-3 study , PHRI, Canada | III | 2015-20 | Completed |
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