COVID-19 Convalescent Plasma
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|ClinicalTrials.gov Identifier: NCT04340050|
Recruitment Status : Completed
First Posted : April 9, 2020
Last Update Posted : December 28, 2020
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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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04340050
|United States, Illinois|
|University of Chicago Medicine|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Maria Lucia Madariaga, MD||University of Chicago Biological Sciences Division Department of Surgery|
|Responsible Party:||University of Chicago|
|Other Study ID Numbers:||
|First Posted:||April 9, 2020 Key Record Dates|
|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|
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|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases