COVID-19 Convalescent Plasma

Pilot Study for Use of Convalescent Plasma Collected From Patients Recovered From COVID-19 Disease for Transfusion as an Empiric Treatment During the 2020 Pandemic at the University of Chicago Medical Center

The purpose of this study is to assess the feasibility of delivering anti-SARS-CoV-2 convalescent plasma to hospitalized patients with severe or life-threatening COVID-19.

Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma.

Hypothesis: Collecting and administering convalescent plasma requires a level of logistical coordination that is not available in all centers.

Objective: To establish feasibility for a hospital-based integrated system to collect and administer convalescent plasma to patients with severe or life-threatening COVID-19.

Study Overview

• Status: Completed
• Conditions: Coronavirus
• Intervention / Treatment: Biological: anti-SARS-CoV-2 convalescent plasma

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medicine

Participation Criteria

Eligibility Criteria

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

Description

Donor Inclusion Criteria:

• Age greater or equal to 18
• Able to donate blood per blood bank standard guidelines
• Prior diagnosis of COVID-19 documented by a laboratory test (confirmed)
• Complete resolution of symptoms at least 28 days prior to donation
• Female donors who have never been pregnant, previously pregnant female donors negative for HLA antibodies (HLA screening), or male donors

Donor Exclusion Criteria:

• Does not provide consent
• Does not meet standard blood bank donation guidelines
• Unsuccessful blood donation

Recipient Inclusion Criteria:

• Patients must be 18 years of age or older
• Must have laboratory-confirmed COVID-19

• Must have severe or immediately life-threatening COVID-19

  • Severe defined as dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours
  • Life-threatening defined as respiratory failure, septic shock, and/or multiple organ dysfunction or failure. Lower priority should be given to patients with septic shock or multiple organ dysfunction or failure since their disease may have progressed to a point where they are not able to benefit from convalescent plasma therapy.
• Must be less than 21 days from the start of illness
• Patient is willing and able to provide written informed consent and comply with all protocol requirements. If the patient is not able to consent, we will obtain consent from the power of attorney or a health care proxy for the patient as determined by the Illinois Healthcare Surrogate Act
• Patient, power of attorney or health care proxy agrees to storage of specimens for future testing.
• Of note, eIND application for each recipient subject will need to be approved before administration of convalescent plasma

Recipient Exclusion Criteria:

• Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period
• Receipt of pooled immunoglobulin in past 30 days
• Contraindication to transfusion or history of prior reactions to transfusion blood products
• Patients currently enrolled in other drug trials that preclude investigational treatment with anti-SARS-CoV-2 convalescent 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 with anti-SARS-CoV-2 convalescent plasma; Infusion of one unit of anti-SARS-CoV-2 convalescent plasma ~300 mL over 4 hours	Biological: anti-SARS-CoV-2 convalescent plasma; Infusion of one unit of anti-SARS-CoV-2 convalescent plasma ~300 mL over 4 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of Administering Plasma	Number of patients who receive convalescent plasma	At time of administration
Type of Respiratory Support	Levels of respiratory support will be graded (e.g. room air, high flow oxygen, intubation) to determine the change in type of respiratory support at 28 days.	Until discharge from hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac Arrest	Number of patients experiencing cardiac arrest.	28 days after plasma administration
Transfer to ICU	Number of patients transferred to ICU	28 days
ICU Mortality	Number of patients dying in the ICU	Until discharge
ICU Length of Stay	This will be a continuous outcome defined by the amount of time between plasma administration and discharge from ICU. This will be treated as a time-to-event.	Up to 50 days
Hospital Mortality	Mortality during course of illness	Until discharge
Hospital Length of Stay	This will be a continuous outcome defined by the amount of time between plasma administration and discharge from hospital.	Until discharge
Ventilator-free Days	This will be a continuous outcome defined by the amount of time between plasma administration and the transition from mechanical ventilation to non-invasive respiratory support.	28 days
Overall Survival (28-day Mortality)	28-Day Overall Survival is defined as the status of the patient at the end of 28 days, beginning from the time of plasma administration.	28 days

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Maria Lucia Madariaga, MD, University of Chicago Biological Sciences Division Department of Surgery

Publications and helpful links

General Publications

• Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
• Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2020
• Primary Completion (Actual): December 23, 2020
• Study Completion (Actual): December 23, 2020

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 8, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: COVID19
• 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: IRB20-0523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share individual participant data that is de-identified available to all qualified investigators
• IPD Sharing Time Frame: Upon publication of the major manuscript to be generated from this study. Data will be deposited in an appropriate major database
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

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.: Yes