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

October 14, 2020 updated by: Joseph M. Flynn, D.O., MPH
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Recruiting
        • Norton Audubon Hospital
        • Contact:
        • Contact:
        • 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
      • Louisville, Kentucky, United States, 40241
        • Recruiting
        • Norton Brownsboro Hospital
        • Contact:
        • Contact:
        • 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
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Hospital
        • Contact:
        • Contact:
        • 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
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Norton Women's and Children's Hospital
        • Contact:
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 14 days
Absolute lymphocyte count (10*3/uL)
Time Frame: Through study completion, an average of 14 days
Measure normalization of laboratory parameters for risk
Through study completion, an average of 14 days
reatinine kinase (mg/dL)
Time Frame: Through study completion, an average of 14 days
Measure normalization of laboratory parameters for risk
Through study completion, an average of 14 days
C-reactive protein (mg/dl)
Time Frame: Through study completion, an average of 14 days
Measure normalization of laboratory parameters for risk
Through study completion, an average of 14 days
D-Dimer (ng/ml FEU)
Time Frame: Through study completion, an average of 14 days
Measure normalization of laboratory parameters for risk
Through study completion, an average of 14 days
Interleukin-6 (pg/ml)
Time Frame: Through study completion, an average of 14 days
Measure normalization of laboratory parameters for risk
Through study completion, an average of 14 days
Ferritin (ng/mL)
Time Frame: Through study completion, an average of 14 days
Measure normalization of laboratory parameters for risk
Through study completion, an average of 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joseph M. Flynn, D.O., MPH

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 14, 2020

Primary Completion (ANTICIPATED)

August 1, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

August 6, 2020

First Submitted That Met QC Criteria

August 12, 2020

First Posted (ACTUAL)

August 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 14, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-N0124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Convalescent Plasma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe