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

Covid19 Clinical Trial

Official title:

Convalescent Plasma for the Treatment of Coronavirus Disease 2019

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04554992
• Other study ID #: 00025121
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 20, 2020
• Est. completion date: June 2022

Study information

• Verified date: October 2020
• Source: The Methodist Hospital System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-exempt ion-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

Related Conditions & MeSH terms

• Coronavirus Infections
• Covid19

Intervention

Biological:
• COVID 19 Convalescent Plasma
COVID 19 convalescent plasma is a blood product collected from donors who have recovered from a previous COVID 19 infection

Locations

Country	Name	City	State
United States	Houston Methodist Hopsital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Methodist Hospital System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of serious adverse events related to the treatment intervention.	Total number of grade 3 and above throughout study period	up to 60 days post-transfusion
Primary	Mortality at Day 28 post-hospital admission.	All cause mortality at day 28	up to 28 days post-transfusion
Secondary	Length of hospital stay	Total number of days subjects are hospitalized during study period	up to 60 days post-transfusion
Secondary	Length of supplemental oxygen requirement.	Total number of days subjects requires supplemental oxygen during study period	up to 60 days post-transfusion
Secondary	Length of mechanical ventilation requirement.	Total number of days subjects require mechanical ventilation during study period	up to 60 days post-transfusion
Secondary	Length of ICU stay	Total number of days subject is subject stays in the ICU	up to 60 days post-transfusion