COVID-19
Conditions
Keywords
COVID-19
Brief summary
This is a Phase II study. This research study is being conducted to use convalescent donor plasma in seriously ill patients who have COVID-19.
Detailed description
This is an open label phase 2 trial assessing the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute severe respiratory symptoms from COVID-19. Symptomatic patients with clinical or radiological interstitial COVID-19 pneumonia and within 21 days of onset of symptoms will be enrolled in 2 cohorts - an ICU cohort and a hospitalized non-ICU cohort.
Interventions
BIOLOGICALanti-SARS-CoV-2 convalescent plasma
* SARS-CoV-2 convalescent plasma (1-2 units; \ 200-400 mL maximum dose as 7 ml/kg adjusted IBW ) * Study drug will be administered as a single intravenous infusion
Sponsors
Froedtert Hospital
Medical College of Wisconsin
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
131 patients in 2 cohorts (ICU cohort and a hospitalized non-ICU cohort)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years or older 2. Hospitalized as an in-patient with positive COVID-19 test by PCR 3. Presence of respiratory symptoms with any of severe features as below: * Respiratory Rate ≥ 24/min * Oxygen Support \>3L/min by nasal cannula * New onset or worsening of respiratory symptoms with radiologic confirmation of bilateral ground glass opacities that cannot be attributed to another cause 4. Patient / HCPOA must agree to storage of blood specimens for future testing. 5. Patient / HCPOA is willing and able to provide electronic informed consent and comply with all protocol requirements. If patient is unable to consent due to incapacity, health care POA should be defined and able to consent for the patient. 6. Patients are allowed to receive all standard of care. Co enrollment in other clinical trials is permitted.
Exclusion criteria
1. FCBP with positive pregnancy test (mandatory) 2. Breastfeeding females 3. Receipt of pooled immunoglobulin (e.g. IVIG or other hyperimmune globulin products) in past 14 days. This does not apply to monoclonal antibodies . 4. Mechanical ventilation for \> 14 days 5. Days from symptom onset \>21 days 6. Expected survival \< 72 hours 7. Contraindication to transfusion or history of prior reactions to transfusion blood products including any proven history of TRALI 8. Patients who were previously admitted to ICU cannot be enrolled in the non-ICU cohort. These patients could need ICU level care subsequently and at that time point could be considered for ICU cohort .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Mortality | Duration of patient hospitalization, sometimes exceeding 60 days | Overall mortality during hospitalization for COVID-19. All patients were followed for the duration of their hospitalization, sometimes exceeding 60 days, through study completion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Admission After Plasma Infusion | Length of admission for COVID through study follow-up period | Length of admission after convalescent plasma infusion for all patients. All enrolled patients, whether they were in the ICU cohort or in the non-ICU cohort, were monitored from the time of consent until the time of hospital discharge. Hospital discharge includes those patients who left the hospital alive and those patients who died during their stay. |
| Length of ICU Stay After Convalescent Plasma Infusion | Length of admission in the ICU for COVID through study follow-up period | Length of ICU stay after plasma infusion for patients who were in the experimental ICU cohort |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ICU Cohort Patients who are in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma.
anti-SARS-CoV-2 convalescent plasma: • SARS-CoV-2 convalescent plasma (1-2 units; \
200-400 mL maximum dose as 7 ml/kg adjusted IBW )
• Study drug will be administered as a single intravenous infusion | 41 |
| Non-ICU Cohort Patients who are NOT in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma.
anti-SARS-CoV-2 convalescent plasma: • SARS-CoV-2 convalescent plasma (1-2 units; \
200-400 mL maximum dose as 7 ml/kg adjusted IBW )
• Study drug will be administered as a single intravenous infusion | 90 |
| Total | 131 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | No blood type specific convalescent plasma was available | 0 | 1 |
Baseline characteristics
| Characteristic | ICU Cohort | Non-ICU Cohort | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 30 Participants | 42 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 60 Participants | 89 Participants |
| BMI | 35.34 kg/m^2 | 34.49 kg/m^2 | 34.76 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 5 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 85 Participants | 121 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 7 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 26 Participants | 40 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 21 Participants | 54 Participants | 75 Participants |
| Region of Enrollment United States | 41 participants | 90 participants | 131 participants |
| Sex: Female, Male Female | 21 Participants | 43 Participants | 64 Participants |
| Sex: Female, Male Male | 20 Participants | 47 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 21 / 41 | 7 / 89 |
| other Total, other adverse events | 0 / 41 | 4 / 89 |
| serious Total, serious adverse events | 12 / 41 | 14 / 89 |
Outcome results
Primary
Overall Mortality
Overall mortality during hospitalization for COVID-19. All patients were followed for the duration of their hospitalization, sometimes exceeding 60 days, through study completion.
Time frame: Duration of patient hospitalization, sometimes exceeding 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ICU Cohort | Overall Mortality | 22 Participants |
| Non-ICU Cohort | Overall Mortality | 7 Participants |
Secondary
Length of Admission After Plasma Infusion
Length of admission after convalescent plasma infusion for all patients. All enrolled patients, whether they were in the ICU cohort or in the non-ICU cohort, were monitored from the time of consent until the time of hospital discharge. Hospital discharge includes those patients who left the hospital alive and those patients who died during their stay.
Time frame: Length of admission for COVID through study follow-up period
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ICU Cohort | Length of Admission After Plasma Infusion | 13.24 days |
| Non-ICU Cohort | Length of Admission After Plasma Infusion | 7.85 days |
Secondary
Length of ICU Stay After Convalescent Plasma Infusion
Length of ICU stay after plasma infusion for patients who were in the experimental ICU cohort
Time frame: Length of admission in the ICU for COVID through study follow-up period
Population: Only patients in the ICU Cohort were assessed for this outcome measure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ICU Cohort | Length of ICU Stay After Convalescent Plasma Infusion | 11.98 days |