Clinical Trial Protocol Developed By ICMR For Covid-19 Treatment

Indian Council of Medical Research proposal for the clinical trial of convalescent plasma in Covid-19 has been approved by the central drug regulator. The protocol to be followed is as per the one developed by ICMR. DCGI has already expressed that ICMR has selected a list of institutes who have shown interest in the trial to the Central Drugs Standard Control Organization and they can continue doing so after prior consultation with the concerned health research body.

It was informed to the public that the complete proposal of ICMR for conducting the convalescent plasma trial has been reviewed by the subject expert committee in a meeting that was held on April 13 regarding the speeding up of the approval process.

It is because of the prevailing covid19 situation and due to the committee recommendation. CDSCO has given it no objection for the conductance to some of the amendments present in the protocol and several other conditions under the Drugs and Clinical Trial Rules 2019. As it was said by the central drug regulator in the notice.

The whole concept of convalescent plasma therapy involves isolating the antibodies from those patients' blood who have recovered from Covid-19 to treat the infected patients. The study keeps an aim in assessing the effectiveness of the convalescent plasma for decreasing the complications in COVID-19 patients and to estimate the level of safety in the treatment with anti-SARS-CoV-2 plasma in Covid-19 infected patients.

Until now there are no approved methods of treatment for Covid-19. Several trials are being carried out across the world to learn more about the effectiveness of several treatment methods. ICMR has pursued active participation in the phase-II randomized trial for assessing the effectiveness as well as safety of convalescent plasma.

It is estimated that using convalescent plasma might enhance the clinical outcomes in patients with moderate COVID-19 infection. However, as the studies progress, more refined data about the treatment and even cure of this disease will come under light. Furthermore, CDSCO is also planning to expedite the drug license registration process if a cure or treatment is found soon.