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ICMR announces protocol for Therapeutic Plasma Exchange therapy in COVID-19 patients

ICMR announces protocol for Therapeutic Plasma Exchange therapy in COVID-19 patients

The Indian Council of Medical Research (ICMR) has announced protocol for a multi-center, phase II, open label, randomized controlled study named Therapeutic Plasma Exchange (TPE) in COVID-19 for its therapy. The therapy is also called convalescent plasma therapy which according to health experts has the potential to treat critically ill COVID-19 patients.



The primary objective of the study is to assess the efficacy of TPE in improving the clinical status of COVID-19 patients. It will also evaluate the safety of treatment with anti SARS-CoV-2 plasma in patients with COVID-19. The subjects for inclusion in the trial study are hospitalised COVID-19 patients who are critically ill, fulfill the inclusion and exclusion criteria and are admitted for care at COVID-19 management facilities in India.



“Convalescent plasma is an experimental procedure for COVID-19 patients. Hospitals and institutions planning to provide this modality of treatment should do so in a clinical trial with protocols which are cleared by the Institutional Ethics Committee (IEC)," ICMR stated. In this experimental treatment, plasma of a treated COVID-19 patient is indicated to an existing patient. Theoretically, plasma from a cured patient is assumed to have antibodies against the virus and this can then be used to cure another patient.



The clinical trial is supposed to be two arm, open-label, randomized controlled trial, meaning that patients will either be given convalescent plasma or any conventional therapy on a randomised-basis and each of the patients will know which treatment they are being given.



As per the Letter of Intent (LOI) for participation, the protocols should be registered with the Clinical Trial Registry of India (CTRI:http://ctri.nic.in/Clinicaltrials/login.php). They should also be approved by Drugs Controller General of India (DCGI), Central Drugs Standard Control Organization (CDSCO) (https://cdsco.gov.in/opencms/opencms/en/Home). Mechanisms to report adverse and serious adverse events to the CDSCO should be put in place.



At this moment, ICMR does not recommend this as a treatment option outside of clinical trials.



ICMR has invited LOI from institutions with the equipment and infrastructure available to participate in a clinical trial to study the safety and efficacy of therapeutic plasma exchange in COVID-19 patients, subsequent to necessary approvals and clearances.



Institutions which are interested to collaborate with ICMR on undertaking this trial intervention may express their interest by providing the details through the following link:https://forms.gle/7AaW528DMQbNZsUr9 or contact Dr. Anup Agarwal through Email-mailanupagarwal@gmail.com.

 

More news about: clinical trials | Published by Darshana | April - 15 - 2020 | 295

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