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COVID-19 Convalescent Plasma | Clinical Trials | Clareo Health

COMPLETEDEARLY_PHASE1

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

NCT04340050•University of Chicago

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
•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.
+4 more criteria

Exclusion Criteria

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

Locations (1)

University of Chicago Medicine

Chicago, Illinois, United States

Key Dates

Start Date

April 10, 2020

Primary Completion Date

December 23, 2020

Completion Date

December 23, 2020

Last Updated

February 28, 2024

Enrollment

ACTUAL participants

Conditions

Coronavirus

Interventions

anti-SARS-CoV-2 convalescent plasma

BIOLOGICAL

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

NCT06631287

Long COVIDSars-CoV-2 Infection+2 more

View study

RECRUITING

Post COVID-19 Biorepository

NCT04885504

Coronavirus Infection

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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COVID-19 Convalescent Plasma

Inclusion Criteria

Exclusion Criteria

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

Post COVID-19 Biorepository

Capturing MultiORgan Effects of COVID-19

Risk Factors for Community- and Workplace Transmission of COVID-19

ODYSSEY: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 Infection

COVID-19 Biorepository