COVID
Conditions
Brief summary
The plan is to transfuse COVID-19 infected patients with convalescent plasma and observe whether this will result in a significant improvement in clinical outcome in comparison to historical experience.
Interventions
BIOLOGICALConvalescent Plasma
200-425mL convalescent plasma donated by patients previously positive for COVID-19
Sponsors
Northside Hospital, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented COVID-19 infection by nasal pharyngeal sampling * COVID-19 disease falling into one of the following groups: * Critical disease: respiratory failure requiring mechanical ventilation, pressor support, or multiple organ dysfunction/failure * Severe disease: tachypnea \>/=30 per min, O2 sats \</=93% at rest, PaO2/FiO2 index \</=300mmHg * High Risk: upper respiratory symptoms but no radiographic evidence of disease, immunocompromised, insulin-dependent diabetes, poorly controlled HIV disease, moderate to severe asthma history, severe COPD, morbid obesity (BMI \>/=40, age \>/=65 years * Health Care Providers: health care providers at risk to exposure to COVID-19 infection or those with mild to non-severe disease
Exclusion criteria
* History of IgA deficiency * History of anaphylatic reaction to blood product transfusion including hypersensitivity to immunoglobulin therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arms 1 & 2: Number of COVID-19 Infected Patients in Severe, High Risk & Health Care Provider Cohorts Who Survive the Infection | 30 days after initial treatment | Number of patients who survived the covid infection after treatment on study. |
Countries
United States
Participant flow
Recruitment details
Enrollment period 7/14/2020-9/13/2021 Subjects were recruited from the hospital, outpatient clinic and from marketing efforts
Participants by arm
| Arm | Count |
|---|---|
| Critical Patients Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19 | 0 |
| Severe Patients Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19 | 1 |
| High Risk Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19 | 6 |
| Health Care Providers Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19 | 1 |
| Total | 8 |
Baseline characteristics
| Characteristic | High Risk | Health Care Providers | Total | Severe Patients |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 1 Participants | 7 Participants | 1 Participants |
| Age, Continuous | 37 years | 25 years | 37 years | 63 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 1 Participants | 5 Participants | 1 Participants |
| Region of Enrollment United States | 6 participants | 1 participants | 8 participants | 1 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Male | 4 Participants | 0 Participants | 4 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 | 0 / 6 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 0 / 1 | 0 / 6 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 | 0 / 6 | 0 / 1 |
Outcome results
Primary
Arms 1 & 2: Number of COVID-19 Infected Patients in Severe, High Risk & Health Care Provider Cohorts Who Survive the Infection
Number of patients who survived the covid infection after treatment on study.
Time frame: 30 days after initial treatment
Population: no critical patients were enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Critical Patients | Arms 1 & 2: Number of COVID-19 Infected Patients in Severe, High Risk & Health Care Provider Cohorts Who Survive the Infection | 0 Participants |
| Severe Patients | Arms 1 & 2: Number of COVID-19 Infected Patients in Severe, High Risk & Health Care Provider Cohorts Who Survive the Infection | 1 Participants |
| High Risk | Arms 1 & 2: Number of COVID-19 Infected Patients in Severe, High Risk & Health Care Provider Cohorts Who Survive the Infection | 6 Participants |
| Health Care Providers | Arms 1 & 2: Number of COVID-19 Infected Patients in Severe, High Risk & Health Care Provider Cohorts Who Survive the Infection | 1 Participants |