Regulation/Guidelines

CDSCO Notified Information On Convalescent Plasma In COVID-19

  • 20th August, 2020
CDSCO notified information on Convalescent Plasma in COVID-19

A growing number of research centres, hospitals are investigating antibody testing and blood- plasma therapy as a way to fight the new coronavirus in sick patients. People who survive an infectious disease like COVID-19 are left with antibody-rich blood plasma or convalescent plasma made to fight off the virus. Researchers are predicting convalescent plasma can be a lifeline for corona virus-infected individuals. This can be transfused into newly infected patients to aid recovery. Since the beginning of the pandemic, doctors have been transfusing convalescent plasma into critically ill COVID-19 patients.

The Ministry of Health and Family Welfare, Government of India on 27th June 2020, came out with CLINICAL MANAGEMENT PROTOCOL: COVID-19 Version 4.On the basis of the protocol, CDSCO issued a notice on 1 st July, 2020 in reference of the protocol. Certain therapies in the protocol are indicated for use as investigational therapies, in which convalescent plasma by plasmapheresis has been indicated as “Off Label” in COVID-19 patients. Convalescent plasma may be considered in patients with the moderate disease who are not improving (oxygen requirement is progressively increasing) despite the use of steroids.

Requirements for considering convalescent plasma in COVID-19

  • ABO compatibility and cross matching of the convalescent plasma donor
  • 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).
  • To avoid transfusion related adverse events for several hours post transfusion recipient must be monitored
  • Convalescent plasma avoided in patients with IgA deficiency or immunoglobulin allergy

Dosage of convalescent plasma: The dose is variable ranging from 4 to 13 ml/kg (usually 200 ml single dose given slowly over not less than 2 hour according to the CLINICAL MANAGEMENT PROTOCOL: COVID19 Version 4

Presently, the use of these therapies is based on limited available evidence. As the COVID-19 situation evolves and more data are available, the evidence will be incorporated, and clinical protocol upgrades. Moreover, an informed and shared decision making is needed by the medical experts before prescribing this therapy.

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