Articles
Clinical Trial Protocol Developed By ICMR For Covid-19 Treatment
by Dolly K. Digital Marketing ExecutiveIndian 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.
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About Dolly K. 
Digital Marketing Executive
33 connections, 4 recommendations, 183 honor points.Joined APSense since, March 24th, 2020, From New Delhi, India.
Created on Sep 18th 2020 10:59. Viewed 286 times.
