Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection
NCT ID: NCT04513158
Last Updated: 2024-10-24
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE2
Total Enrollment
2 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-08-14
Study Completion Date
2021-04-28
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Covid19
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
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).
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
Convalescent Plasma
Intervention Type
BIOLOGICAL
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.
Interventions
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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.
Intervention Type
BIOLOGICAL
Eligibility Criteria
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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.
* 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
* 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.
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
99 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Joseph M. Flynn, D.O., MPH
OTHER
Sponsor Role
lead
Responsible Party
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Joseph M. Flynn, D.O., MPH
Principal Investigator
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Joseph M Flynn, DO, MPH
Role: PRINCIPAL_INVESTIGATOR
Norton Healthcare
Locations
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Norton Hospital
Louisville, Kentucky, United States
Site Status
Norton Women's and Children's Hospital
Louisville, Kentucky, United States
Site Status
Norton Audubon Hospital
Louisville, Kentucky, United States
Site Status
Norton Brownsboro Hospital
Louisville, Kentucky, United States
Site Status
Countries
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United States
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20-N0124
Identifier Type: -
Identifier Source: org_study_id
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