Clinical Research - SRM Medical College Hospital and Research Centre
Clinical Research

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.

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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