COVID
Conditions
Brief summary
The purpose of this study is to find out if transfusion of blood plasma containing antibodies against COVID-19 (anti-SARS-CoV-2), which were donated from a patient who recovered from COVID-19 infection, is safe and can treat COVID-19 in hospitalized patients. Antibodies are blood proteins produced by the body in response to a virus and can remain in the person's bloodstream (plasma) for a long time after they recover. Transferring plasma from a person who recovered from COVID-19 may help neutralize the virus in sick patients' blood, and/or reduce the chances of the infection getting worse.
Interventions
BIOLOGICALConvalescent Plasma
450-550 mL of plasma containing anti-SARS-CoV-2 antibody titer ideally \> 1:320, but meeting minimum titer per FDA Guidelines for convalescent plasma.
BIOLOGICALStandard Donor Plasma
450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Staff in Transfusion Services (Blood Bank) at Stony Brook will be unblinded so they can collect, store, and dispense either convalescent plasma or standard plasma. They will affix an approved label with all required information, e.g. bar code, blood type, expiration date, and will indicate that the bag contains convalescent plasma/standard plasma.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
There are 2 groups of research subjects: plasma donor and recipients Volunteer plasma donors can donate Convalescent Plasma if they: * have adequate antibody levels against COVID-19 per FDA Guidelines * have had no symptoms of COVID-19 for at least 14 days * meet routine plasma donation criteria Inclusion Criteria for Plasma Recipients: * Adults 18 years of age or older * Hospitalized with PCR+ COVID-19 infection * If female must not be pregnant and/or breastfeeding.
Exclusion criteria
for Plasma Recipients: * Unable to randomize patient within 14 days of admission to Stony Brook Hospital (or any other hospital if a transfer to Stony Brook Hospital). * In the treating physician's opinion, the patient cannot tolerate a 450-550 mL infusion of plasma over up to 8 hours (4 hours max per unit), even if prophylaxed with intravenous diuretic * Contraindication to transfusion or history of prior reactions to blood transfusions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28 Day Ventilator Free Days | 28 days post randomization | Number of days a patient is receiving mechanical invasive ventilation through 28 days post randomization. Patients who die during this time period are assigned 0 ventilator free days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 90 Day All-cause Mortality | 90 days | All cause mortality from randomization until 90 days post randomization |
Countries
United States
Participant flow
Pre-assignment details
8 screen failures prior to randomization, thus 74 patients were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Convalescent Donor Plasma Convalescent Plasma: 450-550 mL of plasma containing anti-SARS-CoV-2 antibody titer ideally \> 1:320, but meeting minimum titer per FDA Guidelines for convalescent plasma. | 59 |
| Standard Donor Plasma Standard Donor Plasma: 450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies | 15 |
| Total | 74 |
Baseline characteristics
| Characteristic | Convalescent Donor Plasma | Standard Donor Plasma | Total |
|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 15.8 | 64 years STANDARD_DEVIATION 17.4 | 66 years STANDARD_DEVIATION 16.1 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Race/Ethnicity, Customized Black | 5 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Other | 12 Participants | 6 Participants | 18 Participants |
| Race/Ethnicity, Customized White | 42 Participants | 8 Participants | 50 Participants |
| Sex: Female, Male Female | 23 Participants | 7 Participants | 30 Participants |
| Sex: Female, Male Male | 36 Participants | 8 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 16 / 59 | 5 / 15 |
| other Total, other adverse events | 0 / 59 | 0 / 15 |
| serious Total, serious adverse events | 8 / 59 | 1 / 15 |
Outcome results
Primary
28 Day Ventilator Free Days
Number of days a patient is receiving mechanical invasive ventilation through 28 days post randomization. Patients who die during this time period are assigned 0 ventilator free days.
Time frame: 28 days post randomization
Population: All randomized
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Convalescent Donor Plasma | 28 Day Ventilator Free Days | 28 days |
| Standard Donor Plasma | 28 Day Ventilator Free Days | 28 days |
Secondary
90 Day All-cause Mortality
All cause mortality from randomization until 90 days post randomization
Time frame: 90 days
Population: All randomized
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Convalescent Donor Plasma | 90 Day All-cause Mortality | 16 Participants |
| Standard Donor Plasma | 90 Day All-cause Mortality | 5 Participants |