Recently, India’s drug research apparatus—starting with the top Central Drugs Standard Control Organization (CDSCO) and the lead research agency—the Indian Council for Medical Research (ICMR) approved the use of convalescent plasma therapy for COVID-19 patients. Hospitals now must receive approval from the ICMR prior to treating patients fitting the inclusion criteria. An unfortunate event occurred as a hospital site may have not followed the protocol treating a critically ill patient. But perhaps the really didn’t have a choice. Unfortunately, the first patient that underwent such convalescent plasma therapy in the State of Maharashtra, a 53-year old male, passed in Mumbai’s Lilavati Hospital as the state readies Brihanmumbai Municipal Corporation (BMC)-run Kasturba Hospital as a specialized plasma therapy hub in this part of India.
COVID-19 in India: Maharashtra the Most Cases
With about 114 million people, Maharashtra state includes Mumbai and is India’s second most populated state. It also leads India’s COVID-19 cases. Nationwide these cases are growing with 42,670 countrywide. 1,395 have died if not more depending on how accuracy of records. In Maharashtra state, 12,296 cases are now reported along with 521 deaths—leading the entire country.
The COVID-19 Convalescent Plasma Study
Known as convalescent plasma, this investigational approach is not a proven treatment. In India, like the United States, a pre-requisite for conducting plasma therapy is the approval of the appropriate regulatory authority. In the case of India a hospital must secure approval from ICMR which was afforded approval by the country’s drug regulator Central Drugs Standard Control Organization (CDSCO). On April 17, CDSCO gave ICMR the greenlight to commence an open label, randomized, controlled Phase II study to assess the safety and efficacy of the experimental convalescent plasma therapy in patients with moderate COVID-19 infection, reports Ridhima Saxena with LiveMint.
ICMR Convalescent Plasma Guidelines
ICMR established guidelines for COVID-19 convalescent therapy such as the patient must be 18 or over; provide written informed consent and those patients that are critically-ill, pregnant or breastfeeding women or anyone with any hypersensitivity to blood products must be excluded.
What Occurred at Lilavati Hospital?
Lilavati Hospital, a private health care facility located in the suburbs of Mumbai was the site of the first COVID-19 convalescent plasma transfusion in Maharashtra State. Proceeding with the administration of the convalescent therapy to a critical patient infected with SARS-CoV-2, the hospital acted without ICMR approval.
According to the hospital’s CEO, V Ravishankar, ‘”The patient came to us after 10 days of developing the infection. He had badly damaged lungs and was put on a ventilator, so his condition was critical from the day he came to us.” The CEO continued, “When his condition didn’t improve, we gave him the latest antiviral drug Tocilizumab, after which showed little improvement. Since we found the plasma matching his blood group, we tried the plasma therapy. But the COVID-19 pneumonia had damaged both his lungs and he died of acute respiratory distress syndrome,” reported Ravishankar.
According to Ravishankar, the hospital in fact received approval to conduct the trial on the patient from the regional head Om Shrivastav—a leading infectious disease specialist and part of a nine-member task force set up by the Maharashtra government, comprising specialist physicians to minimize the death rate and monitor clinical management of critical COVID-19 patients.
It sounds like the CEO received the provisional approval for Lilavati Hospital to conduct the study if the story is accurate. It would also appear that they deviated from the protocol as it excluded critically ill patents. However, with a patient violently ill with SARS-CoV-2-triggered ARDS, they had few if any options. They had to try something to save the man’s life. The approval process could become a little more systematic and methodical as well from the sounds of it but we haven’t studied it sufficiently to make a conclusive statements.