Written by Sandeep A Ashar | Mumbai | Published: June 11, 2020 3:54:47 am
At the epicentre of the pandemic, Maharashtra has so far reported 90,787 cases and 3,289 deaths. (Representational)
India’s Central Drug Authority on Tuesday permitted the Maharashtra government to undertake convalescent plasma therapy trials in severe Covid-19 patients at 21 government medical college hospitals (GMCHs).
Earlier, Dr Sushant Meshram, Dean, Government Medical College, Nagpur, and the trial’s principal investigator, had sought the drug authority’s permission for conducting multi-centric plasma trials in severe Covid-19 cases in a randomised control format.
In a letter addressed to Dr Meshram on June 8, Dr V G Somani, Central Licensing Authority, Central Drugs Standard Control Organisation (CDSCO), wrote, “With reference to your (Maharashtra government’s) letter dated June 4, 2020, please find enclosed herewith permission to conduct the clinical trial under the provisions of the New Drugs and Clinical Trial Rules, 2019, based on the evaluation in consultation with the subject Expert Committee.” The CDSCO functions under the Centre’s Directorate General of Health Services.
While GMC, Nagpur, will be the trial’s lead institution, senior officials confirmed that it will be extended throughout the state in 20 other government medical college hospitals as well. In Mumbai, the trials will be conducted at Grant Medical College and civic-run King Edward Memorial hospital, Lokmanya Tilak Municipal General Hospital and Dr RN Cooper Hospital.
Maharashtra’s Medical Education secretary Dr Sanjay Mukherjee, the trial’s sponsor, when contacted, confirmed the development. The Centre’s permission letter, a copy of which is with The Indian Express, however, states that “co-morbid patients with coronary artery diseases, heart failure, and arrhythmia should be excluded from the study.” According to senior state officials, this will be “the largest trial in the world for the use of convalescent plasma as therapy in severe cases.” Earlier on May 8, the Indian Council of Medical Research (ICMR) had approved 28 institutions across India to conduct convalescent plasma trials in cases exhibiting mild and moderate symptoms. In Maharashtra government hospitals, 16 trials have so far been carried out at BYL Nair Hospital (Mumbai), BG Medical Hospital (Pune), GMC (Nagpur) and GMC (Kolhapur). “The results were encouraging,” an official said, prompting Maharashtra, too, to opt for a multi-centric trial.
At the epicentre of the pandemic, Maharashtra has so far reported 90,787 cases and 3,289 deaths. The Drug Authority’s permission letter states that “before initiation of the trial, an undertaking would have to be submitted by all investigators including pulmonologist involved in the study.” It has further said that “submission of consent documents, information sheets, consent forms and approvals from the ethics committee will be necessary before the initiation of study.” Trial at each of the 21 sites will be initiated only after approvals of the trial’s protocol by the local Ethics Committee. It has also said that the “trial shall be registered with the Clinical Trial Registry of India maintained by the ICMR before enrolling the first subject of trial.”
The study, dubbed Platina, will however require a month’s time for preparations. Following the Centre’s approval, officials said that dedicated plasma pheresis machines for separation of plasma from the donor’s blood cells will be procured for state-controlled blood banks. The government will also write to the National Institute of Virology (NIV) for anti-body titration or the process of identifying the correct concentration of anti-bodies to be infused in a patient. Officials admitted that the biggest challenge before the government was to find donors willing to be a part of the study. For plasma trial, the donor must be someone who has recovered from Covid-19 in the recent past. Patients who recovered from a severe infection are more suited as donors. The state is planning to launch a campaign to locate donors.
📣 The Indian Express is now on Telegram. Click here to join our channel (@indianexpress) and stay updated with the latest headlines
For all the latest India News, download Indian Express App.
© The Indian Express (P) Ltd