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

Sponsor
Joseph M. Flynn, D.O., MPH (Other)
Overall Status
Recruiting
CT.gov ID
NCT04513158
Collaborator
(none)
100
Enrollment
4
Locations
1
Arm
16.6
Anticipated Duration (Months)
25
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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).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 :
Aug 14, 2020
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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.

Outcome Measures

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). [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 [Through study completion, an average of 14 days]

    SARS-CoV-2 Ag levels through RT-PCR

  2. Absolute lymphocyte count (10*3/uL) [Through study completion, an average of 14 days]

    Measure normalization of laboratory parameters for risk

  3. reatinine kinase (mg/dL) [Through study completion, an average of 14 days]

    Measure normalization of laboratory parameters for risk

  4. C-reactive protein (mg/dl) [Through study completion, an average of 14 days]

    Measure normalization of laboratory parameters for risk

  5. D-Dimer (ng/ml FEU) [Through study completion, an average of 14 days]

    Measure normalization of laboratory parameters for risk

  6. Interleukin-6 (pg/ml) [Through study completion, an average of 14 days]

    Measure normalization of laboratory parameters for risk

  7. Ferritin (ng/mL) [Through study completion, an average of 14 days]

    Measure normalization of laboratory parameters for risk

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts 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:

    1. D-Dimer > 500 ng/ml FEU OR
    1. IL-6> 5 pg/mL
With any of the following:
    1. Lymphocytes < 0.8 103/ul OR
    1. LDH > 700 U/L OR
    1. CK > 170 U/L OR
    1. CRP > 1.0 mg/dl OR
    1. Ferritin > 1000 ng/ml
AND one of the following:
    1. Age over 60 years
    1. Underlying Active Malignancy
    1. Cardiovascular Disease
    1. Active Tobacco Use
    1. History of Pulmonary Volume Reduction Surgery
    1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Norton Hospital Louisville Kentucky United States 40202
2 Norton Women's and Children's Hospital Louisville Kentucky United States 40207
3 Norton Audubon Hospital Louisville Kentucky United States 40217
4 Norton Brownsboro Hospital Louisville Kentucky United States 40241

Sponsors and Collaborators

  • Joseph M. Flynn, D.O., MPH

Investigators

  • Principal Investigator: Joseph M Flynn, DO, MPH, Norton Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Joseph M. Flynn, D.O., MPH, Principal Investigator, Norton Healthcare
ClinicalTrials.gov Identifier:
NCT04513158
Other Study ID Numbers:
  • 20-N0124
First Posted:
Aug 14, 2020
Last Update Posted:
Oct 19, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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, Principal Investigator, Norton Healthcare
SARS-CoV-2
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Oct 19, 2020