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

Convalescent Plasma for the Treatment of Coronavirus Disease 2019

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.

Study Overview

• Status: Unknown
• Conditions: Covid19
• Intervention / Treatment: Biological: COVID 19 Convalescent Plasma

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hopsital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; All subjects recruited will be transfused with COVID 19 convalescent plasma. A prospective comparison with matched historical controls receiving standard care will be employed.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Mortality at Day 28 post-hospital admission.	All cause mortality at day 28	up to 28 days post-transfusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Total number of days subjects are hospitalized during study period	up to 60 days post-transfusion
Length of supplemental oxygen requirement.	Total number of days subjects requires supplemental oxygen during study period	up to 60 days post-transfusion
Length of mechanical ventilation requirement.	Total number of days subjects require mechanical ventilation during study period	up to 60 days post-transfusion
Length of ICU stay	Total number of days subject is subject stays in the ICU	up to 60 days post-transfusion

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute
• Investigators: Principal Investigator: Eric Salazar, MD, PhD, The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 00025121

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No