COVID-19 Convalescent Plasma

Early Phase 1

Completed

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.

Recruitment & Eligibility

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

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

Arm && Interventions

Group	Intervention	Description
Treatment with anti-SARS-CoV-2 convalescent plasma	anti-SARS-CoV-2 convalescent plasma	Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours

Primary Outcome Measures

Name	Time	Method
Type of Respiratory Support	Until discharge from hospital	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.
Success of Administering Plasma	At time of administration	Number of patients who receive convalescent plasma

Secondary Outcome Measures

Name	Time	Method
ICU Mortality	Until discharge	Number of patients dying in the ICU
Hospital Length of Stay	Until discharge	This will be a continuous outcome defined by the amount of time between plasma administration and discharge from hospital.
Ventilator-free Days	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.
Cardiac Arrest	28 days after plasma administration	Number of patients experiencing cardiac arrest.
Transfer to ICU	28 days	Number of patients transferred to ICU
ICU Length of Stay	Up to 50 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	Until discharge	Mortality during course of illness
Overall Survival (28-day Mortality)	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.