Convalescent Plasma in the Treatment of COVID 19

September 22, 2020 updated by: Saint Francis Care
The purpose of this study is to collect blood from previously COVID-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening COVID-19 infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this prospective interventional study is to gain clinical experience using convalescent plasma transfusion administered to critically ill patients with COVID-19.

1 To study the efficacy of plasma from patients recovered from COVID-19 infection with a high neutralizing antibody titer (NAT) as treatment for individuals who are critically ill with COVID-19.

2. Determine if the antibodies from convalescent plasma will suppress virus load in critically ill patients with COVID-19.

Study Type

Interventional

Enrollment (Actual)

48

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 Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Trinity Health Of New England

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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All genders
  • Age > 18 yrs and < 90 yrs
  • Must have laboratory confirmed COVID-19
  • Must provide informed consent
  • Must have severe or immediately life-threatening COVID-19,

Severe disease is defined as:

  • dyspnea,
  • respiratory frequency ≥ 30/min,
  • blood oxygen saturation ≤ 93%,
  • partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
  • lung infiltrates > 50% within 24 to 48 hours

Life-threatening disease is defined as:

  • respiratory failure,
  • septic shock
  • multiple organ dysfunction or failure

Exclusion Criteria:

  • No gender exclusion
  • Age < 18 yrs and > 90 yrs
  • COVID-19 negative

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COVID-19 patients treated with convalescent plasma
Severely ill COVID-19 patients treated with convalescent plasma
Biological: Convalescent Plasma
treatment with 2 Units of convalescent plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Up to 28 days
Mortality within 28 days
Up to 28 days
Viral Load
Time Frame: Day 0, Day 3, Day 5, and Day 7

Median Viral Load at Day 0, Day 3, Day 5, and Day 7 Plasma Viral Load was measured using a research-use only real-time reverse transcription polymerase chain reaction (rRT -PCR) method which targets two regions of the SARS-CoV-2 N gene using TaqMan chemistry.

The limit of detection for this assay is 75 copies/mL (standard curve of 75 copies/mL to 10,000,000 copies/mL of in vitro transcribed RNA prepared from the full SARS-CoV-2 N gene).
Day 0, Day 3, Day 5, and Day 7
Serum Antibody Titers
Time Frame: Day 0, Day 3, Day 5, and Day 7
Median Serum Antibody Titers at Day 0, Day 3, Day 5 and Day 7 Serum Antibody titers were measured using chemiluminescent SARS-CoV-2 immunoglobulin G (IgG) assay from Diazyme (Poway, CA) Positive IgG serum value is > or = 1.0 arbitrary units/mL [AU/mL] (linear reportable range for IgG is 0.20 - 100.00 AU/mL)
Day 0, Day 3, Day 5, and Day 7

Collaborators and Investigators

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

Sponsor

Saint Francis Care

Investigators

  • Principal Investigator: Latha Dulipsingh, MD, Saint Francis Hospital and Medical Centerr/Trinity Health Of New England

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)

April 10, 2020

Primary Completion (Actual)

July 23, 2020

Study Completion (Actual)

August 13, 2020

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 8, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

September 24, 2020

Last Update Submitted That Met QC Criteria

September 22, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFH-20-23

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 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Clinical Trials on Convalescent Plasma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe