Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

TERMINATED

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

Lead Sponsor:

Joseph M. Flynn, D.O., MPH

Conditions:

Covid19

Eligibility:

All Genders

18-99 years

Phase:

PHASE2

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) ...

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 in...

Eligibility Criteria

Inclusion

  • 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

  • 2.1 Patients who do not meet above inclusion criteria are not eligible.
  • 2.2 Patients may not be receiving any other investigational agents.
  • 2.3 History of allergic reactions attributed to previous transfusion history.
  • 2.4 Respiratory rate \>30/min
  • 2.5 Blood oxygen saturation \<93%
  • 2.6 Partial pressure of arterial oxygen to fraction of inspired oxygen ration \<300
  • 2.7 Diagnosis of respiratory failure, septic shock or multiple organ dysfunction/failure

Key Trial Info

Start Date :

August 14 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 28 2021

Estimated Enrollment :

2 Patients enrolled

Trial Details

Trial ID

NCT04513158

Start Date

August 14 2020

End Date

April 28 2021

Last Update

October 24 2024

Active Locations (4)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (4 locations)

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