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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04513158
Recruitment Status : Recruiting
First Posted : August 14, 2020
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Joseph M. Flynn, D.O., MPH, Norton Healthcare

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.

Condition or disease Intervention/treatment Phase
Covid19 Biological: Convalescent Plasma Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection
Actual Study Start Date : August 14, 2020
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: 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.
Biological: 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.




Primary Outcome Measures :
  1. 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). [ Time Frame: 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 Outcome Measures :
  1. Determine the immunologic effects of convalescent plasma infusion [ Time Frame: Through study completion, an average of 14 days ]
    SARS-CoV-2 Ag levels through RT-PCR

  2. Absolute lymphocyte count (10*3/uL) [ Time Frame: Through study completion, an average of 14 days ]
    Measure normalization of laboratory parameters for risk

  3. reatinine kinase (mg/dL) [ Time Frame: Through study completion, an average of 14 days ]
    Measure normalization of laboratory parameters for risk

  4. C-reactive protein (mg/dl) [ Time Frame: Through study completion, an average of 14 days ]
    Measure normalization of laboratory parameters for risk

  5. D-Dimer (ng/ml FEU) [ Time Frame: Through study completion, an average of 14 days ]
    Measure normalization of laboratory parameters for risk

  6. Interleukin-6 (pg/ml) [ Time Frame: Through study completion, an average of 14 days ]
    Measure normalization of laboratory parameters for risk

  7. Ferritin (ng/mL) [ Time Frame: Through study completion, an average of 14 days ]
    Measure normalization of laboratory parameters for risk



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 > 1500 ng/ml FEU AND
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04513158


Contacts
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Contact: Joseph M Flynn, DO, MPH 502-272-5001 Joseph.flynn@nortonhealthcare.org
Contact: Marti Gardner, MSN, APRN 502-629-3550 Marti.Gardner@nortonhealthcare.org

Locations
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United States, Kentucky
Norton Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Jackie Bourke, RN    502-479-1217 ext 157    Jackie.bourke@nortonhealthcare.org   
Contact: Jayne Carwile, RN, MSN    502-479-1217 ext 142    Jayne.Carwile@nortonhealthcare.org   
Principal Investigator: Joseph M Flynn, DO, MPH         
Sub-Investigator: Don A Stevens, MD         
Sub-Investigator: Paul Schulz, MD         
Sub-Investigator: Joseph J Maly, MD         
Sub-Investigator: Khuda D Khan, MD, PhD         
Norton Women's and Children's Hospital Recruiting
Louisville, Kentucky, United States, 40207
Contact: Jackie Bourke, RN    502-479-1217 ext 157    Jackie.bourke@nortonhealthcare.org   
Contact: Jayne Carwile, RN, MSN    502-479-1217 ext 142    Jayne.Carwile@nortonhealthcare.org   
Principal Investigator: Joseph M Flynn, DO, MPH         
Sub-Investigator: Don A Stevens, MD         
Sub-Investigator: Paul Schulz, MD         
Sub-Investigator: Joseph J Maly, MD         
Sub-Investigator: Khuda D Khan, MD, PhD         
Norton Audubon Hospital Recruiting
Louisville, Kentucky, United States, 40217
Contact: Jackie Bourke, RN    502-479-1217 ext 157    Jackie.bourke@nortonhealthcare.org   
Contact: Jayne Carwile, RN, MSN    502-479-1217 ext 142    Jayne.Carwile@nortonhealthcare.org   
Principal Investigator: Joseph M Flynn, DO, MPH         
Sub-Investigator: Don A Stevens, MD         
Sub-Investigator: Paul Schulz, MD         
Sub-Investigator: Joseph J Maly, MD         
Sub-Investigator: Khuda D Khan, MD, PhD         
Norton Brownsboro Hospital Recruiting
Louisville, Kentucky, United States, 40241
Contact: Jackie Bourke, RN    502-479-1217 ext 157    Jackie.bourke@nortonhealthcare.org   
Contact: Jayne Carwile, RN, MSN    502-479-1217 ext 142    Jayne.Carwile@nortonhealthcare.org   
Principal Investigator: Joseph M Flynn, DO, MPH         
Sub-Investigator: Don A Stevens, MD         
Sub-Investigator: Paul Schulz, MD         
Sub-Investigator: Joseph J Maly, MD         
Sub-Investigator: Khuda D Khan, MD, PhD         
Sponsors and Collaborators
Joseph M. Flynn, D.O., MPH
Investigators
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Principal Investigator: Joseph M Flynn, DO, MPH Norton Healthcare
Publications:
The Novel Coronavirus Pneumonia Emergency Response Epidemiology Team. The Epidemiological Characteristics of an Outbreak of 2019 Novel Coronavirus Diseases (COVID-19) - China, 2020[J]. China CDC Weekly, 2020, 2(8): 113-122. doi: 10.46234/ccdcw2020.032
Robeck J. Convalescent Plasma to Treat COVID-19. JAMA - J Am Med Assoc. 2020;Mar 27(Published online).

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Responsible Party: Joseph M. Flynn, D.O., MPH, Principal Investigator, Norton Healthcare
ClinicalTrials.gov Identifier: NCT04513158    
Other Study ID Numbers: 20-N0124
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joseph M. Flynn, D.O., MPH, Norton Healthcare:
SARS-CoV-2
Additional relevant MeSH terms:
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Infection