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Date: 2020-07-01 Category: Not Applicable State: Union Government Country: India

Information on convalescent plasma in Covid 19

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • The gazette notification, dated July 1, 2020, issued by the Central Drugs Standard Control Organisation (CDSCO), references the Ministry of Health and Family Welfare's clinical management protocol for COVID-19, version 4, dated June 27, 2020.
  • It clarifies the use of convalescent plasma as an 'Off Label' investigational therapy for COVID-19 patients.
  • The notification outlines specific prerequisites and considerations for using convalescent plasma, including patient selection criteria, donor plasma characteristics, and monitoring requirements.

Key Changes

  • Convalescent plasma may be considered for moderate COVID-19 patients whose oxygen requirements are progressively increasing despite steroid use.
  • Prerequisites for convalescent plasma use include ABO compatibility and cross matching of donor plasma.
  • The neutralizing titer of donor plasma should be above a specific threshold, or plasma IgG titer (against S-protein RBD) should be above 1:640.
  • Recipients must be closely monitored post-transfusion for adverse events.
  • Use should be avoided in patients with IgA deficiency or immunoglobulin allergy.
  • The dose is variable, ranging from 4 to 13 ml/kg, typically a 200 ml single dose given slowly over at least 2 hours.

Impact Analysis

Healthcare Providers

  • Action Item: Review and update hospital protocols to align with the CDSCO notification and the referenced clinical management protocol.

Pharmaceutical Companies and Plasma Collection Centers

  • Action Item: Review and update donor screening and plasma processing procedures to align with the new requirements.

Patients

  • Action Item: Develop patient education materials to explain the use of convalescent plasma and potential side effects.

Research Institutions

  • Action Item: Design and conduct research studies to assess the impact of donor plasma titer levels on patient outcomes.

Key Entities Referenced

Central Drugs Standard Control Organisation (CDSCO): The national regulatory body for pharmaceuticals and medical devices in India. Directorate General of Health Services (DGHS): A government organization under the Ministry of Health and Family Welfare responsible for public health matters. Ministry of Health and Family Welfare: The government ministry responsible for health policy in India. CLINICAL MANAGEMENT PROTOCOL: COVID-19: A guideline issued by the Government of India, Ministry of Health and Family Welfare, Directorate General of Health Services providing guidance on the clinical management of COVID-19.
Official Source Record View Original Source →
See Full Document Text
File No. X.11026/179/2020-BD Government of India Director General of Health Services Central Drugs Standard Control organisation (Biological Division) FDA Bhawan, Kotla Road, New Delhi-110002 Date:1st July 2020 Information on Convalescent Plasma in COVID-19 This is with reference to the CLINICAL MANAGEMENT PROTOCOL: COVID- 19 issued by the Government of India, Ministry of Health and Family Welfare, Directorate General of Health Services dated 27-06-2020 Version 4, wherein, certain therapies are indicated for use as investigational therapies, in which convalescent plasma by plasmapheresis has been indicated as “Off Label” in COVID-19 patients’ stating that- Convalescent plasma may be considered in patients with moderate disease who are not improving (oxygen requirement is progressively increasing) despite use of steroids. Special prerequisites while considering convalescent plasma include: • ABO compatibility and cross matching of the donor plasma. • 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).  Recipient should be closely monitored for several hours post transfusion for any transfusion related adverse events.  Use should be avoided in patients with IgA deficiency or immunoglobulin allergy Dose: Dose is variable ranging from 4 to 13 ml/kg (usually 200 ml single dose given slowly over not less than 2 hour. The link for referring the details in the said guideline issued by the Government of India is as under. https://www.mohfw.gov.in/pdf/ClinicalManagementProtocolforCOVID19dated27062 020.pdf

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