COVID-19 Convalescent Plasma

• ClinicalTrials.gov Identifier: NCT04340050
• Recruitment Status: Completed
• First Posted: April 9, 2020
• Last Update Posted: December 28, 2020
• Sponsor: University of Chicago
• Information provided by (Responsible Party): University of Chicago

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Coronavirus	Biological: anti-SARS-CoV-2 convalescent plasma	Early Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: April 10, 2020
• Actual Primary Completion Date: December 23, 2020
• Actual Study Completion Date: December 23, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Feasibility of performing study pathway consisting of consenting convalescent donors, harvesting convalescent plasma, application for FDA eIND and administering convalescent plasma to the patients [ Time Frame: 28 days after plasma administration ]
   Feasibility will be measured by (number of donors from whom convalescent plasma is harvested/number of interested donors) and number of patients who receive convalescent plasma at day 28.
2. Type of respiratory support [ Time Frame: 28 days after plasma administration ]
   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.

Secondary Outcome Measures :

1. Cardiac arrest [ Time Frame: 28 days after plasma administration ]
   This will be a continuous outcome defined by the amount of time between plasma administration and cardiac arrest.
2. Transfer to ICU [ Time Frame: 28 days ]
   This will be a continuous outcome defined by the amount of time between plasma administration and transfer to ICU.
3. ICU mortality [ Time Frame: 28 days ]
   This will be a binary outcome defined by the amount of time between plasma administration and mortality in the ICU.
4. ICU length of stay [ Time Frame: 28 days ]
   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.
5. Hospital mortality [ Time Frame: 28 days ]
   This will be a binary outcome defined by the amount of time between plasma administration and in-hospital mortality.
6. Hospital length of stay [ Time Frame: 28 days ]
   This will be a continuous outcome defined by the amount of time between plasma administration and discharge from hospital.
7. Ventilator-free days [ Time Frame: 28 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.
8. Overall survival (28-day mortality) [ Time Frame: 28 days ]
   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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Illinois

University of Chicago Medicine

Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT04340050
• Other Study ID Numbers: IRB20-0523
• First Posted: April 9, 2020
• Last Update Posted: December 28, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: We will share individual participant data that is de-identified available to all qualified investigators
• Supporting Materials: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: Upon publication of the major manuscript to be generated from this study. Data will be deposited in an appropriate major database

• 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

Keywords provided by University of Chicago:

COVID19

Additional relevant MeSH terms:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases