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Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection

Primary Purpose

Covid19

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Convalescent Plasma
Sponsored by
Joseph M. Flynn, D.O., MPH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring SARS-CoV-2

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Norton HospitalRecruiting
  • Norton Women's and Children's HospitalRecruiting
  • Norton Audubon HospitalRecruiting
  • Norton Brownsboro HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Determine the immunologic effects of convalescent plasma infusion
SARS-CoV-2 Ag levels through RT-PCR
Absolute lymphocyte count (10*3/uL)
Measure normalization of laboratory parameters for risk
reatinine kinase (mg/dL)
Measure normalization of laboratory parameters for risk
C-reactive protein (mg/dl)
Measure normalization of laboratory parameters for risk
D-Dimer (ng/ml FEU)
Measure normalization of laboratory parameters for risk
Interleukin-6 (pg/ml)
Measure normalization of laboratory parameters for risk
Ferritin (ng/mL)
Measure normalization of laboratory parameters for risk

Full Information

First Posted
August 6, 2020
Last Updated
October 14, 2020
Sponsor
Joseph M. Flynn, D.O., MPH
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1. Study Identification

Unique Protocol Identification Number
NCT04513158
Brief Title
Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection
Official Title
Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2020 (Actual)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joseph M. Flynn, D.O., MPH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
SARS-CoV-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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).
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Convalescent Plasma
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Description
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
Secondary Outcome Measure Information:
Title
Determine the immunologic effects of convalescent plasma infusion
Description
SARS-CoV-2 Ag levels through RT-PCR
Time Frame
Through study completion, an average of 14 days
Title
Absolute lymphocyte count (10*3/uL)
Description
Measure normalization of laboratory parameters for risk
Time Frame
Through study completion, an average of 14 days
Title
reatinine kinase (mg/dL)
Description
Measure normalization of laboratory parameters for risk
Time Frame
Through study completion, an average of 14 days
Title
C-reactive protein (mg/dl)
Description
Measure normalization of laboratory parameters for risk
Time Frame
Through study completion, an average of 14 days
Title
D-Dimer (ng/ml FEU)
Description
Measure normalization of laboratory parameters for risk
Time Frame
Through study completion, an average of 14 days
Title
Interleukin-6 (pg/ml)
Description
Measure normalization of laboratory parameters for risk
Time Frame
Through study completion, an average of 14 days
Title
Ferritin (ng/mL)
Description
Measure normalization of laboratory parameters for risk
Time Frame
Through study completion, an average of 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph M Flynn, DO, MPH
Phone
502-272-5001
Email
Joseph.flynn@nortonhealthcare.org
First Name & Middle Initial & Last Name or Official Title & Degree
Marti Gardner, MSN, APRN
Phone
502-629-3550
Email
Marti.Gardner@nortonhealthcare.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph M Flynn, DO, MPH
Organizational Affiliation
Norton Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norton Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackie Bourke, RN
Phone
502-479-1217
Ext
157
Email
Jackie.bourke@nortonhealthcare.org
First Name & Middle Initial & Last Name & Degree
Jayne Carwile, RN, MSN
Phone
502-479-1217
Ext
142
Email
Jayne.Carwile@nortonhealthcare.org
First Name & Middle Initial & Last Name & Degree
Joseph M Flynn, DO, MPH
First Name & Middle Initial & Last Name & Degree
Don A Stevens, MD
First Name & Middle Initial & Last Name & Degree
Paul Schulz, MD
First Name & Middle Initial & Last Name & Degree
Joseph J Maly, MD
First Name & Middle Initial & Last Name & Degree
Khuda D Khan, MD, PhD
Facility Name
Norton Women's and Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackie Bourke, RN
Phone
502-479-1217
Ext
157
Email
Jackie.bourke@nortonhealthcare.org
First Name & Middle Initial & Last Name & Degree
Jayne Carwile, RN, MSN
Phone
502-479-1217
Ext
142
Email
Jayne.Carwile@nortonhealthcare.org
First Name & Middle Initial & Last Name & Degree
Joseph M Flynn, DO, MPH
First Name & Middle Initial & Last Name & Degree
Don A Stevens, MD
First Name & Middle Initial & Last Name & Degree
Paul Schulz, MD
First Name & Middle Initial & Last Name & Degree
Joseph J Maly, MD
First Name & Middle Initial & Last Name & Degree
Khuda D Khan, MD, PhD
Facility Name
Norton Audubon Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackie Bourke, RN
Phone
502-479-1217
Ext
157
Email
Jackie.bourke@nortonhealthcare.org
First Name & Middle Initial & Last Name & Degree
Jayne Carwile, RN, MSN
Phone
502-479-1217
Ext
142
Email
Jayne.Carwile@nortonhealthcare.org
First Name & Middle Initial & Last Name & Degree
Joseph M Flynn, DO, MPH
First Name & Middle Initial & Last Name & Degree
Don A Stevens, MD
First Name & Middle Initial & Last Name & Degree
Paul Schulz, MD
First Name & Middle Initial & Last Name & Degree
Joseph J Maly, MD
First Name & Middle Initial & Last Name & Degree
Khuda D Khan, MD, PhD
Facility Name
Norton Brownsboro Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackie Bourke, RN
Phone
502-479-1217
Ext
157
Email
Jackie.bourke@nortonhealthcare.org
First Name & Middle Initial & Last Name & Degree
Jayne Carwile, RN, MSN
Phone
502-479-1217
Ext
142
Email
Jayne.Carwile@nortonhealthcare.org
First Name & Middle Initial & Last Name & Degree
Joseph M Flynn, DO, MPH
First Name & Middle Initial & Last Name & Degree
Don A Stevens, MD
First Name & Middle Initial & Last Name & Degree
Paul Schulz, MD
First Name & Middle Initial & Last Name & Degree
Joseph J Maly, MD
First Name & Middle Initial & Last Name & Degree
Khuda D Khan, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
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Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection

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