Kolkata, 6th February 2023: CK Birla Hospitals -CMRI, announced the success of the global doxycycline study trial lead by Dr. Raja Dhar, Director & HOD, Department of Pulmonology, CK Birla Hospitals along with international scientists and physicians . For the last three years Covid-19 has caused devastation all over the world. Not only has human health been negatively impacted, but also death and morbidity have reached its peak. On the other end, health economics and global health infrastructure have been penalized as well. Doxycycline is an inexpensive antibiotic that has been used for many years for several indications and has an excellent safety profile. The antibiotic has anti-inflammatory properties which helps in tissue protection and antioxidative action.
A trial was conducted to test the hypothesis that doxycycline works to stop the progression of Covid-19 infections to prevents ICU admissions in hospitalised patients. This study was conducted by six hospitals starting from the end of 2020 and continued till June 2021. Most of the patients were recruited between April 2021- June 2021 when there was the greatest deluge of severe cases. Dr. Raja Dhar, heading the Pulmonology department at the CMRI Hospitals in Kolkata, was the Principle Investigator and oversaw the entire study process. The other participating centres were Ruby Hall Clinic in Pune, Yashoda Super Specialty Hospital in Ghaziabad, UP, Saroj Super specialty Hospital and Jaipur Golden Hospital in Delhi, Kalyan Hospital and Sterling Hospital in Vadodara, and Yashoda Hospital in Hyderabad. The app for this study was designed by Dr Stephan D. Gadola, Clinical Immunologist and Research Scientist from Basel, John Kirkpatrick, Senior Principal Statistical Scientist, Cambridge. Prof Ratko Djukanovic, current Head of the Respiratory and Critical Care, Southampton NIHR Biomedical Research Centre, along with Professor Stephan Gadola and Dr Raja Dhar conceptualized the study, supervised it, and ultimately wrote up the study. Mr John Krikpatrick a highly skilled statistically scientist did all the statistics for the study. Additionally, Senior Scientist Laura Gilbert from UK, Marcel Stern and Oliver T. Keppler, Germany gave scientific inputs for this study. Hence, the study had experts from throughout the globe.
There were 387 participants who participated in the study. 77 developed critical diseases needing ICU admission. The arm in which doxycycline was given had an absolute and relative risk reduction compared to the arm which did not have doxycycline. The reduction was significant by statistical analysis. Doxycycline was also well tolerated and not a single patient required stoppage of treatment due to adverse events. The conclusion was that in hospitalized COVID-19 patients, doxycycline was a safe and inexpensive treatment widely available throughout the globe and it reduced ICU admissions when added to standard of care. The electronic case record form was hosted on a secure Amazon Web service. Instructions for its use were sent to all participants and several online training sessions were held, including completion of mock patient data. Collection of data in this situation and uploading it on the ECRF, cleaning the data, and then doing statistical analysis was a massive challenge for the Indian investigators, which they circumvented with a lot of courage and passion. This study was on a shoestring budget with hardly any funding available for it. The study provides a new template for multicenter investigator lead studies done with minimal funding in a diverse country like India with International collaboration during extremely distressing times.
Dr Dhar speaking about this trial said ” The trial was carried out in the midst of the deadly second Covid- 19 wave in India and circumstances could not have been more challenging . This has been an excellent pragmatic and very friendly collaboration by experts across multiple continents and we are greatly encouraged by the findings for this well-known and widely available antibiotic.”
About CMRI (The Calcutta Medical Research Institute)
A multi-specialty hospital in Kolkata is the flagship hospital of the CK Birla Group of Hospitals. For over 50 years this hospital has been providing unmatched health care service to millions of patients from different parts of India and neighbouring countries. Based on three key principles Clinical Excellence, Ethical Conduct and Patient Centricity this hospital has several eminent physicians, surgeons and health care providers of national and international repute. Apart from clinical excellence, patients experience care and empathy from internationally trained nurses which ensures holistic care for millions of patients who have come to us over the years.