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. 2020 Nov 10;91(4):e2020175. doi: 10.23750/abm.v91i4.10681

Supplementary Table 1.

Patient Eligibility for eINDs for use of COVID-19 convalescent plasma to treat patients (Adapted from FDA)

Diagnostic criteria fulfillment Laboratory confirmed COVID-19
Clinical/laboratory criteria Severe disease is defined as one or more of the following:
  • Shortness of breath (dyspnea),

  • Respiratory frequency ≥ 30/min,

  • Blood oxygen saturation ≤ 93%,

  • Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300,

  • Lung infiltrates > 50% within 24 to 48 hours

Life-threatening disease is defined as one or more of the following:
  • Respiratory failure,

  • Septic shock,

  • Multiple organ dysfunction or failure

Consent
  • Informed consent provided by the patient or healthcare proxy.

Adapted from https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/recommendations-investigational-covid-19-convalescent-plasma ( Accessed on 06-02-2020)