Covid19
Conditions
Keywords
SARS-CoV-2
Brief summary
This study proposes to evaluate the therapeutic efficacy, immunologic effects and normalization of laboratory parameters for patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19) when administered one unit (approximately 200 mL) of convalescent plasma administered over a period of one hour. Following administration of the convalescent plasma, physical exam/clinical assessment information is collected daily and routine lab result data is collected every three days.
Detailed description
Following the administration of one unit (approximately 200 mL) of convalescent plasma over one hour, the study proposes to determine the therapeutic efficacy (response rate) of convalescent plasma infusion in patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19) by prevention of progression to severe or life threatening COVID-19 during the current hospitalization as determined by evaluating if the patient experienced the following the following: respiratory rate \>30/min, Blood oxygen saturation \<93%, partial pressure of arterial oxygen to fraction of inspired oxygen ration \<300, or received a medical diagnosis of respiratory failure, septic shock or multiple organ dysfunction/failure. This will be captured from the daily physical exam/clinical assessment done as part of routine care and at discharge. The study also proposes to determine the immunologic effects of convalescent plasma infusion as measured by serial SARS-CoV-2 Ag levels through RT-PCR measured by CoV PCR collected at enrollment, day 7 and discharge. Finally, the study intends to measure normalization of laboratory parameters for risk which will be documented every 3 days while the patient is hospitalized until the time that lab value returns to within the institution's normal range.
Interventions
BIOLOGICALConvalescent Plasma
Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent.
Sponsors
Joseph M. Flynn, D.O., MPH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All hospitalized patients meeting study inclusion/exclusion criteria and providing informed consent for participation in the study will receive one unit (approximately 200 mL) of convalescent plasma over one hour to with data collection of routine physical exams/clinical assessments (daily) and routine lab results (every 3 days).
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of SARS-CoV-2 infection via RT-PCR or FDA approved testing. * Patients must also have the following indications for enrollment: * i. D-Dimer \> 500 ng/ml FEU OR * ii. IL-6\> 5 pg/mL With any of the following: * iii. Lymphocytes \< 0.8 103/ul OR * iv. LDH \> 700 U/L OR * v. CK \> 170 U/L OR * vi. CRP \> 1.0 mg/dl OR * vii. Ferritin \> 1000 ng/ml AND one of the following: * viii. Age over 60 years * ix. Underlying Active Malignancy * x. Cardiovascular Disease * xi. Active Tobacco Use * xii. History of Pulmonary Volume Reduction Surgery * xiii. Hypertension * Prior Treatment: Patients are still eligible for this trial if active antimicrobial agents are in use. Patients are also eligible if they had been treated on COVID-19 clinical trial in the course of their disease. * Age ≥ 18 years. * The effects of allogeneic plasma infusion on the developing fetus is unknown. For this reason women who are pregnant are not eligible to participate. * Agrees to required laboratory data collected which will include the baseline organ function and regular ongoing assessments done as part of routine care. * Ability to understand and the willingness to sign a written informed consent document or ability to have consent provided by Legally Authorized Representative.
Exclusion criteria
* 4.2.1 Patients who do not meet above inclusion criteria are not eligible. * 4.2.2 Patients may not be receiving any other investigational agents. * 4.2.3 History of allergic reactions attributed to previous transfusion history. * 4.2.4 Respiratory rate \>30/min * 4.2.5 Blood oxygen saturation \<93% * 4.2.6 Partial pressure of arterial oxygen to fraction of inspired oxygen ration \<300 * 4.2.7 Diagnosis of respiratory failure, septic shock or multiple organ dysfunction/failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the Therapeutic Efficacy (Response Rate) of Convalescent Plasma Infusion in Patients at High Risk for Mortality When Infected by SARS-CoV-2 (COVID-19). | Through study completion, an average of 30 days | Measured by respiratory rate \>30/min, blood oxygen saturation \<93%, partial pressure of arterial oxygen to fraction of inspired oxygen ration \<300 and received a medical diagnosis of respiratory failure, septic shock or multiple |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Lymphocyte Count (10*3/uL) | Through study completion, an average of 14 days | Measure normalization of laboratory parameters for risk |
| Reatinine Kinase (mg/dL) | Through study completion, an average of 14 days | Measure normalization of laboratory parameters for risk |
| C-reactive Protein (mg/dl) | Through study completion, an average of 14 days | Measure normalization of laboratory parameters for risk |
| Determine the Immunologic Effects of Convalescent Plasma Infusion | Through study completion, an average of 14 days | SARS-CoV-2 Ag levels through RT-PCR |
| Interleukin-6 (pg/ml) | Through study completion, an average of 14 days | Measure normalization of laboratory parameters for risk |
| Ferritin (ng/mL) | Through study completion, an average of 14 days | Measure normalization of laboratory parameters for risk |
| D-Dimer (ng/ml FEU) | Through study completion, an average of 14 days | Measure normalization of laboratory parameters for risk |
Countries
United States
Participant flow
Pre-assignment details
This study was open label, so there was no pre-assignment.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm Study is single arm all patients hospitalized meeting inclusion/exclusion criteria and providing informed consent to receive one unit (approximately 200 mL) of convalescent plasma with data collected daily on routine (non-research) clinical assessments/physical exams and lab results.
Convalescent Plasma: Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent. | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screen Failure | 1 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Determine the Therapeutic Efficacy (Response Rate) of Convalescent Plasma Infusion in Patients at High Risk for Mortality When Infected by SARS-CoV-2 (COVID-19).
Measured by respiratory rate \>30/min, blood oxygen saturation \<93%, partial pressure of arterial oxygen to fraction of inspired oxygen ration \<300 and received a medical diagnosis of respiratory failure, septic shock or multiple
Time frame: Through study completion, an average of 30 days
Population: Data was not collected or analyzed.
Secondary
Absolute Lymphocyte Count (10*3/uL)
Measure normalization of laboratory parameters for risk
Time frame: Through study completion, an average of 14 days
Population: Data was not collected or analyzed.
Secondary
C-reactive Protein (mg/dl)
Measure normalization of laboratory parameters for risk
Time frame: Through study completion, an average of 14 days
Population: Data was not collected or analyzed.
Secondary
D-Dimer (ng/ml FEU)
Measure normalization of laboratory parameters for risk
Time frame: Through study completion, an average of 14 days
Population: Data was not collected or analyzed.
Secondary
Determine the Immunologic Effects of Convalescent Plasma Infusion
SARS-CoV-2 Ag levels through RT-PCR
Time frame: Through study completion, an average of 14 days
Population: Data was not collected or analyzed.
Secondary
Ferritin (ng/mL)
Measure normalization of laboratory parameters for risk
Time frame: Through study completion, an average of 14 days
Population: Data was not collected or analyzed.
Secondary
Interleukin-6 (pg/ml)
Measure normalization of laboratory parameters for risk
Time frame: Through study completion, an average of 14 days
Population: Data was not collected or analyzed.
Secondary
Reatinine Kinase (mg/dL)
Measure normalization of laboratory parameters for risk
Time frame: Through study completion, an average of 14 days
Population: Data was not collected or analyzed.