India is set to launch Convalescent Plasma Therapy (CPT), a treatment involving plasma obtained from blood of cured coronavirus patients to treat those who arecritically ill. The Indian Council of Medical Research (ICMR) has invited Letter of Intent (LoI) for participation in studies to validate Therapeutic Plasma Exchange (TPE), an experimental procedure to treat critically ill coronavirus patients.
In plasma therapy, about 800 ml of blood is extracted from a fully recovered coronavirus patient to isolate plasma rich with antibodies.
This plasma is then infused into the blood stream of other coronavirus patients. When the body gets into contact with external pathogens like bacteria or germs, it automatically triggers a defence mechanism, releasing antibodies.
The plasma from cured coronavirus patients contain antibodies that have already fought the pathogen - the coronavirus.
Studies show CPT's 'encouraging' efficacy in treatment of coronavirus patients in the absence of effective medicines or vaccines. China, South Korea, US and UK are also experimenting with CPT. India is following their footsteps.
Hospitals and institutions planning to provide plasma treatment have to conduct a clinical trial with protocols which are cleared by the Institutional Ethics Committee (IEC). They must also be registered with the Clinical Trial Registry of India (CTRI) and get approval from the Drugs Controller General of India (DCGI) before initiating the trial.
ICMR has clarified that it does not recommend this as a treatment option outside of clinical trials at the moment, though patients admitted for care at coronavirus management facilities will be eligible for inclusion in the trial.
TESTS IN KERALA
Kerala is the first state to initiate the protocol for plasma therapy. The Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) under the Department of Science and Technology, was given a go ahead on April 11 by ICMR.
But approval from the DCGI is pending as there are rules like the blood donor should not have travelled abroad in the past three months.
"We have applied to the Drug Controller General of India (DCGI) for permissions to relax the norms for blood donation," said Dr Asha Kishore Director, SCTIMST.
Kerala had initiated research and protocols for the plasma therapy even before the US Food and Drug Administration (FDA) approved it on April 3. ICMR sources said it would take a few days to ascertain how many trials have been allowed, since the official letter of intent was publicised only a couple of days ago.
Use of convalescent plasma has been studied during the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic. The treatment was also tried for Ebola, but it wasn't very promising, say researchers.
According to a Journal of the American Medical Association (JAMA) study published on March 27, researchers found CPT led to "an improvement in clinical status" of five critically-ill patients with coronavirus and ARDS (acute respiratory distress syndrome). A study published on April 6 by the Proceedings of the National Academy of Sciences (PNAS) also show 'encouraging results with CPT used in coronavirus infected patients'.
"Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19. Therefore, it is important to study the safety and efficacy of COVID-19 convalescent plasma in clinical trials", observes the US FDA, while giving clearance to the therapy.
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