Coronavirus
Conditions
Keywords
COVID19
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.
Interventions
BIOLOGICALanti-SARS-CoV-2 convalescent plasma
Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \ 300 mL over 4 hours
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of Administering Plasma | At time of administration | Number of patients who receive convalescent plasma |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU Mortality | Until discharge | Number of patients dying in the 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 |
| Cardiac Arrest | 28 days after plasma administration | Number of patients experiencing cardiac arrest. |
| 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. |
| 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. |
| 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. |
| Transfer to ICU | 28 days | Number of patients transferred to ICU |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \
300 mL over 4 hours
anti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \
300 mL over 4 hours | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Treatment With Anti-SARS-CoV-2 Convalescent Plasma |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| BMI | 28.7 kg/m2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| interval symptoms to plasma transfusion | 12 days |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Success of Administering Plasma
Number of patients who receive convalescent plasma
Time frame: At time of administration
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Success of Administering Plasma | Successful | 10 Participants |
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Success of Administering Plasma | Unsuccessful | 0 Participants |
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.
Time frame: Until discharge from hospital
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Type of Respiratory Support | At time of administration | ECMO | 2 Participants |
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Type of Respiratory Support | At time of administration | Ventilator | 1 Participants |
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Type of Respiratory Support | At time of administration | High flow nasal cannula | 1 Participants |
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Type of Respiratory Support | At time of administration | Nasal cannula | 5 Participants |
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Type of Respiratory Support | At time of administration | Room air | 1 Participants |
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Type of Respiratory Support | At time of administration | Deceased | 0 Participants |
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Type of Respiratory Support | At time of discharge | ECMO | 0 Participants |
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Type of Respiratory Support | At time of discharge | Ventilator | 0 Participants |
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Type of Respiratory Support | At time of discharge | High flow nasal cannula | 0 Participants |
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Type of Respiratory Support | At time of discharge | Nasal cannula | 3 Participants |
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Type of Respiratory Support | At time of discharge | Room air | 5 Participants |
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Type of Respiratory Support | At time of discharge | Deceased | 2 Participants |
Secondary
Cardiac Arrest
Number of patients experiencing cardiac arrest.
Time frame: 28 days after plasma administration
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Cardiac Arrest | Cardiac arrest | 0 Participants |
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Cardiac Arrest | No cardiac arrest | 10 Participants |
Secondary
Hospital Length of Stay
This will be a continuous outcome defined by the amount of time between plasma administration and discharge from hospital.
Time frame: Until discharge
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Hospital Length of Stay | 36.2 days |
Secondary
Hospital Mortality
Mortality during course of illness
Time frame: Until discharge
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Hospital Mortality | Deceased | 2 Participants |
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Hospital Mortality | Alive | 8 Participants |
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.
Time frame: Up to 50 days
Population: The 7 patients who were admitted to the ICU
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | ICU Length of Stay | 20 days |
Secondary
ICU Mortality
Number of patients dying in the ICU
Time frame: Until discharge
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | ICU Mortality | Deceased | 2 Participants |
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | ICU Mortality | Survived ICU treatment | 5 Participants |
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | ICU Mortality | Never in ICU | 3 Participants |
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.
Time frame: 28 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Overall Survival (28-day Mortality) | Deceased | 0 Participants |
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Overall Survival (28-day Mortality) | Alive | 10 Participants |
Secondary
Transfer to ICU
Number of patients transferred to ICU
Time frame: 28 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Transfer to ICU | Transferred to ICU | 1 Participants |
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Transfer to ICU | Already in ICU | 5 Participants |
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Transfer to ICU | Readmitted and placed in ICU | 1 Participants |
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Transfer to ICU | Never in ICU | 3 Participants |
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.
Time frame: 28 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment With Anti-SARS-CoV-2 Convalescent Plasma | Ventilator-free Days | 21.7 days |