Convalescent Plasma for the Treatment of COVID-19

Convalescent Plasma for the Treatment of Patients With COVID-19

This protocol provides access to investigational convalescent plasma for patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. Following provision of informed consent, patients will be transfused with 1-2 units of ABO compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2 (as detailed in separate protocol). Safety information collected will include serious adverse events judged to be related to administration of convalescent plasma. Other information to be collected will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated), and survival to discharge from acute care facility.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Convalescent Plasma

Detailed Description

This is an open-label expanded access program to make appropriately matched convalescent plasma available for the treatment of patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. COVID-19 convalescent plasma will be obtained from the Jefferson Blood Bank and will meet all regulatory requirements for conventional plasma and FDA's additional considerations for COVID-19 convalescent plasma (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds).

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

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:

• Age 18 years and older
• Laboratory confirmed diagnosis of SARS-CoV-2
• Admitted to an acute care facility for the treatment of COVID-19 complications
• Informed consent provided by patient or legally authorized representative
• Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease

Severe Disease defined as any of the following

• Dyspnea
• Respiratory rate > 30/minute
• Oxygen saturation <94%
• Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300
• Lung infiltrates >50% within 24 to 48 hours

Life-threatening disease defined as any of the following

• Respiratory failure
• Septic shock
• Multiple organ dysfunction or failure • Informed consent provided by patient or healthcare proxy

Exclusion Criteria:

• Receipt of pooled immunoglobulin in past 30 days
• Contraindication to transfusion or history of prior reactions to transfusion blood products

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: Intervention Group; Participants included in the experimental group will receive 200-600 milliliters of convalescent plasma, administered at a rate of 100-250 mL/hr	Drug: Convalescent Plasma; One to two units (200-600 mL) of ABO compatible COVID-19 convalescent plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who receive COVID-19 convalescent plasma transfusions in acute care facilities infected with SARS-CoV-2	Number of patients who are consented and ultimately receive convalescent plasma transfusion.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and type of adverse events associated with COVID-19 convalescent plasma in patients with COVID-19	Adverse Events including transfusion reaction (fever, rash), transfusion related acute lung injury (TRALI), transfusion associated circulatory overload (TACO), and transfusion infection	0, 1, 2, 3, 7, 14 days
Length of hospital stay	Days of hospitalization	0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Length of Intensive Care Unit stay	Days of Intensive Care Unit management	0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Length of intubation	Days of intubation requirement	0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Survival to discharge	Proportion of patients who are successfully discharged from acute care facility	0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Changes in complete blood count in patients after receiving convalescent plasma	Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).	0 and 7 days
Abnormal changes in Basic Metabolic Panel (BMP) measures in patients after receiving convalescent plasma	BMP tests include measures of glucose, calcium, sodium, potassium, bicarbonate, chloride, blood urea nitrogen, and creatinine. Changes of interest include those that are flagged as abnormal. Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).	0 and 7 days
Changes in C-Reactive Protein (CRP) in patients after receiving convalescent plasma	Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).	0 and 7 days
Changes in d-dimer in patients after receiving convalescent plasma	Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).	0 and 7 days
Changes in fibrinogen in patients after receiving convalescent plasma	Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).	0 and 7 days
Changes in prothrombin time (PT) in patients after receiving convalescent plasma	Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).	0 and 7 days
Changes in partial thromboplastin time (PTT) in patients after receiving convalescent plasma	Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).	0 and 7 days

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2020
• Primary Completion (Actual): November 3, 2020
• Study Completion (Actual): December 7, 2020

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: June 1, 2021

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: 20D.379

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No