Coronavirus, COVID, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Conditions
Keywords
SARS-CoV-1, COVID, Coronavirus, convalescent plasma, plasma
Brief summary
The purpose of this study is to collect blood from previously COVID-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening COVID-19 infection.
Detailed description
The purpose of this prospective interventional study is to gain clinical experience using convalescent plasma transfusion administered to critically ill patients with COVID-19. 1 To study the efficacy of plasma from patients recovered from COVID-19 infection with a high neutralizing antibody titer (NAT) as treatment for individuals who are critically ill with COVID-19. 2\. Determine if the antibodies from convalescent plasma will suppress virus load in critically ill patients with COVID-19.
Interventions
BIOLOGICALConvalescent Plasma
treatment with 2 Units of convalescent plasma
Sponsors
Trinity Health Of New England
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* All genders * Age \> 18 yrs and \< 90 yrs * Must have laboratory confirmed COVID-19 * Must provide informed consent * Must have severe or immediately life-threatening COVID-19, Severe disease is defined as: * dyspnea, * respiratory frequency ≥ 30/min, * blood oxygen saturation ≤ 93%, * partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300 * lung infiltrates \> 50% within 24 to 48 hours Life-threatening disease is defined as: * respiratory failure, * septic shock * multiple organ dysfunction or failure
Exclusion criteria
* No gender exclusion * Age \< 18 yrs and \> 90 yrs * COVID-19 negative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Up to 28 days | Mortality within 28 days |
| Viral Load | Day 0, Day 3, Day 5, and Day 7 | Median Viral Load at Day 0, Day 3, Day 5, and Day 7 Plasma Viral Load was measured using a research-use only real-time reverse transcription polymerase chain reaction (rRT -PCR) method which targets two regions of the SARS-CoV-2 N gene using TaqMan chemistry. The limit of detection for this assay is 75 copies/mL (standard curve of 75 copies/mL to 10,000,000 copies/mL of in vitro transcribed RNA prepared from the full SARS-CoV-2 N gene). |
| Serum Antibody Titers | Day 0, Day 3, Day 5, and Day 7 | Median Serum Antibody Titers at Day 0, Day 3, Day 5 and Day 7 Serum Antibody titers were measured using chemiluminescent SARS-CoV-2 immunoglobulin G (IgG) assay from Diazyme (Poway, CA) Positive IgG serum value is \> or = 1.0 arbitrary units/mL \[AU/mL\] (linear reportable range for IgG is 0.20 - 100.00 AU/mL) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| COVID-19 Patients Treated With Convalescent Plasma Severely ill COVID-19 patients treated with convalescent plasma
Convalescent Plasma: treatment with 2 Units of convalescent plasma | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | received inadequate amount of antibodies | 7 |
Baseline characteristics
| Characteristic | COVID-19 Patients Treated With Convalescent Plasma |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 24 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age, Continuous | 65 years STANDARD_DEVIATION 12.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 48 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 22 / 48 |
| other Total, other adverse events | 8 / 48 |
| serious Total, serious adverse events | 8 / 48 |
Outcome results
Primary
Mortality
Mortality within 28 days
Time frame: Up to 28 days
Population: 48 patients with severe or life threatening disease with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection enrolled in the study. 7 patients were excluded from analysis due to receiving plasma with insufficient antibodies.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COVID-19 Patients Treated With Convalescent Plasma | Mortality | 19 Participants |
Primary
Serum Antibody Titers
Median Serum Antibody Titers at Day 0, Day 3, Day 5 and Day 7 Serum Antibody titers were measured using chemiluminescent SARS-CoV-2 immunoglobulin G (IgG) assay from Diazyme (Poway, CA) Positive IgG serum value is \> or = 1.0 arbitrary units/mL \[AU/mL\] (linear reportable range for IgG is 0.20 - 100.00 AU/mL)
Time frame: Day 0, Day 3, Day 5, and Day 7
Population: 39 out of 41 patients had blood collected on day 0 (pre-transfusion), and on post-transfusion day 3 (n=36), 5 (n=30), and 7 (n=24) and serum antibody titers was assessed at each time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| COVID-19 Patients Treated With Convalescent Plasma | Serum Antibody Titers | SARS-CoV-2 Antibodies Day 0 | 18.5 arbitrary units/mL (AU/mL) |
| COVID-19 Patients Treated With Convalescent Plasma | Serum Antibody Titers | SARS-CoV-2 Antibodies Day 3 | 37.2 arbitrary units/mL (AU/mL) |
| COVID-19 Patients Treated With Convalescent Plasma | Serum Antibody Titers | SARS-CoV-2 Antibodies Day 5 | 47.4 arbitrary units/mL (AU/mL) |
| COVID-19 Patients Treated With Convalescent Plasma | Serum Antibody Titers | SARS-CoV-2 Antibodies Day 7 | 55.2 arbitrary units/mL (AU/mL) |
Primary
Viral Load
Median Viral Load at Day 0, Day 3, Day 5, and Day 7 Plasma Viral Load was measured using a research-use only real-time reverse transcription polymerase chain reaction (rRT -PCR) method which targets two regions of the SARS-CoV-2 N gene using TaqMan chemistry. The limit of detection for this assay is 75 copies/mL (standard curve of 75 copies/mL to 10,000,000 copies/mL of in vitro transcribed RNA prepared from the full SARS-CoV-2 N gene).
Time frame: Day 0, Day 3, Day 5, and Day 7
Population: Plasma viral load data was available for 35 out of 41 convalescent plasma recipients on day 0. 22 patients out of 35 had non-detectable levels at Day 0; 25 patients out of 34 had non-detectable levels on Day 3; 20 patients out of 27 had non-detectable levels on Day 5; 20 patients out of 24 had non-detectable levels on Day 7.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| COVID-19 Patients Treated With Convalescent Plasma | Viral Load | Detectable Viral Load Day 0 | 3524 copies per mL |
| COVID-19 Patients Treated With Convalescent Plasma | Viral Load | Detectable Viral Load Day 3 | 2033 copies per mL |
| COVID-19 Patients Treated With Convalescent Plasma | Viral Load | Detectable Viral Load Day 5 | 315 copies per mL |
| COVID-19 Patients Treated With Convalescent Plasma | Viral Load | Detectable Viral Load Day 7 | 494 copies per mL |