TRAC: TFORD Retrospective Analysis for COVID-19
The TFORD has initiated a Retrospective Study in Pune recently. The details of the study are provided below:
Title : Retrospective Assessment of Treatments of Hospitalized Covid-19 Patients
CTRI Registration Number : CTRI/2020/05/025371 [Registered on: 27/05/2020] Trial Registered Prospectively
• To collect clinical management information for COVID-19 patients.
• To evaluate the efficacy and safety of currently used treatments for hospitalised COVID19 patients
Principal Investigator: Dr Sundeep Salvi, Advisory Group, TFORD
Clinical Research Lead: Dr Ravindra Ghooi, Advisory Group, TFORD
Other Team members:
- Dr Chitra Lele
- Dr Madhur Motwani
- Dr Santhosh Dixit
- Dr Priya Nagaraj
- Dr Premnath V
Sponsor: Venture Center, Pune (acting on behalf of TFORD)
Project Location : Pune
Project Description: This is an observational study (not involving use of drugs or patients) which aims to collect data on treatment and clinical management modalities being used in hospitals for COVID-19 patients in Pune. Data will be collected from hospitals in Pune about patients that have been treated for COVID-19 Infections. The data will include demographic data such as age and gender, treatments, outcomes, medical and treatment history, concurrent medical conditions, need for other intervention such as ventilators, renal replacement therapy etc. Data will be analyzed using appropriate statistical methods and tools There will be no direct involvement of any patient in the study. Data will be collected of patients after they have left the hospital, either discharged or died. As no patients are involved, and the study will collect only non-identifiable data, there are no ethical issues involved. The study has been approved by a DCGI approved Ethics Committee. The Study will be conducted as per the New Drug and Clinical Trial Rules, 2019 of CDSCO (Central Drug Standards Control Organization), Ministry of Health and Family Welfare, Government of India, National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2017 ICMR, ICH (International Conference on Harmonization) E6 (R2) “Guideline for Good Clinical Practice”, Declaration of Helsinki (Ethical principles for Medical Research involving Human subjects, revised by WMA General Assembly, Fortaleza, Brazil October 2013).
Potential impact of the project: In order to design better trials and chose potential therapies effectively, there is a need to understand what kind of symptoms patients are presenting with, the kind of therapies being used by doctors for clinical management and their effects. We believe this study, which aims to collect and curate clinical management information of COVID-19 patients will significantly aid in understanding which therapies could be most beneficial for the Indian population and going further aid in their testing through clinical trials. After an initial study in Pune, if results warrant it, we would recommend the conduct of such a study on a National basis.
Contact person at Venture Center: Navnath Kadam, Email: firstname.lastname@example.org