Convalescent Plasma for the Treatment of COVID-19 (Coronavirus Disease 2019)

The Methodist Hospital Research Institute350 enrolled

Overview

This pilot, prospective study will assess the safety and efficacy of COVID-19 convalescent plasma versus standard care as treatment for severe and/or critical COVID-19 (as defined in the inclusion criteria) in adults 18 years of age and older. A total of 350 eligible subjects will receive a transfusion of anti-SARS-CoV2 ( severe acute respiratory syndrome) convalescent plasma.

Patients meeting inclusion/exclusion criteria will be approached for study consent based on the time of hospital admission and the availability of an blood type compatible product. 300mL plasma units of COVID-19 convalescent patients will be utilized for transfusion. During a period of 14 days, the patient will be eligible to receive up to 10 units of plasma, to be completed with 4 hours as per institutional transfusion standard operating procedures. Transfusion by apheresis (plasma exchange) may be employed to reduce the risk of volume overload. The number of units to be used will be determined by the study team based on protocol inclusion and exclusion criteria, and clinical evaluation of the patient's severity and response. Subjects will be followed for at least 60 days or up to 3 months following initial transfusion for adverse event monitoring and data collection.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

350

Conditions

Covid19

Interventions

COVID 19 Convalescent PlasmaBIOLOGICAL

COVID 19 convalescent plasma is a blood product collected from donors who have recovered from a previous COVID 19 infection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Recipient must meet criteria outlined in the recent Investigational COVID-19 Convalescent Plasma - Emergency INDs (investigational new drug) guidance (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds) Exclusion Criteria: 1. History of prior severe reactions to transfusion of blood products with imputability of probable or definite as defined by Center of Disease Control National Healthcare Safety Network Hemovigilance Module \[see https://www.cdc.gov/nhsn/PDFs/Biovigilance/BV-HV-protocol-current.pdf\]. 2. Has underlying uncompensated and untreatable end stage disease. 3. Fluid overload or other condition that would contraindicate administration of plasma

Locations (1)

Houston Methodist Hopsital

Houston, Texas, United States

Outcomes

Primary Outcomes

Cumulative incidence of serious adverse events related to the treatment intervention.

Total number of grade 3 and above throughout study period

Time frame: up to 60 days post-transfusion

Mortality at Day 28 post-hospital admission.

All cause mortality at day 28

Time frame: up to 28 days post-transfusion

Secondary Outcomes

Length of hospital stay

Total number of days subjects are hospitalized during study period

Time frame: up to 60 days post-transfusion

Length of supplemental oxygen requirement.

Total number of days subjects requires supplemental oxygen during study period

Time frame: up to 60 days post-transfusion

Length of mechanical ventilation requirement.

Total number of days subjects require mechanical ventilation during study period

Time frame: up to 60 days post-transfusion

Length of ICU stay

Total number of days subject is subject stays in the ICU

Time frame: up to 60 days post-transfusion

Data from ClinicalTrials.gov

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