COVID-19 Convalescent Plasma

The University of Chicago

Status and phase

Completed

Early Phase 1

Conditions

Coronavirus

Treatments

Biological: anti-SARS-CoV-2 convalescent plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT04340050

IRB20-0523

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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