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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04340050
Other study ID # IRB20-0523
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date April 10, 2020
Est. completion date December 23, 2020

Study information

Verified date February 2024
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 23, 2020
Est. primary completion date December 23, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
anti-SARS-CoV-2 convalescent plasma
Infusion of one unit of anti-SARS-CoV-2 convalescent plasma ~300 mL over 4 hours

Locations

Country Name City State
United States University of Chicago Medicine Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Success of Administering Plasma Number of patients who receive convalescent plasma At time of administration
Primary 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 Cardiac Arrest Number of patients experiencing cardiac arrest. 28 days after plasma administration
Secondary Transfer to ICU Number of patients transferred to ICU 28 days
Secondary ICU Mortality Number of patients dying in the ICU Until discharge
Secondary 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
Secondary Hospital Mortality Mortality during course of illness Until discharge
Secondary 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
Secondary 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
Secondary 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
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