Date: 02-Jul-2020

CDSCO Comes Out With New Criteria On CP Therapy To Monitor Patients For Transfusion Related Adverse Events

The Central Drugs Standard Control organization (CDSCO) has come out with a set of new criteria on convalescent plasma (CP) therapy based on Union health ministry’s guidelines to monitor patients post transfusion for any transfusion related adverse events.

Special prerequisites as per new criteria while considering CP also include ABO compatibility and cross matching of the donor plasma. This also includes neutralizing titer of donor plasma should be above the specific threshold. If the latter is not available, plasma IgG titer (against S-protein RBD) above 1:640 should be used.  Use of CP should be avoided in patients with IgA deficiency or immunoglobulin allergy. Dose should be variable ranging from 4 to 13 ml/kg (usually 200 ml single dose given slowly over not less than 2 hour).

The new guidelines on ‘Clinical Management Protocol: COVID-19’ by the Union health ministry was released on June 27, 2020. According to Union health ministry guidelines, CP may be considered in patients with moderate disease who are not improving (oxygen requirement is progressively increasing) despite use of steroids.

CDSCO had in April 2020 granted no objection for conduct of clinical trials for CP therapy as per protocol developed by Indian Council of Medical Research (ICMR). Following the approval, it had directed individuals, institutes and organisations, interested in conduct of trial to seek consultation with ICMR for conduct of clinical trial for CP therapy. The proposal of ICMR for conducting the trial was reviewed through CDSCO subject expert committee (SEC) in a meeting on April 14, 2020 and CP therapy was approved under accelerated approval process in light of the current prevailing situation of COVID-19 and based on the recommendations of the committee. The same has been approved subject to certain amendments in the protocol and various conditions under the new Drugs And Clinical Trial Rules 2019.

ICMR had also shared a list of institutes with CDSCO which have shown interest in the conduct of said trial. As per the protocols, plasma donors will be explained the procedure of plasma donation and the adverse events associated with the process. Among the consenting donors and based on the results, donors will be asked to return on a specified date for plasma donation.

Plasma collection will be done by centrifugal separation using apheresis equipment at the healthcare facility.

The CP therapy management plan is supportive care with supplemental oxygen and mechanical ventilation. Multiple trials are being done across the globe to assess the efficacy of various treatment strategies. US FDA had also approved CP from patients recovered from COVID-19 for the treatment of severe or life threatening COVID-19 infections.