Expanded Access to Convalescent Plasma for Treatment of COVID-19

October 7, 2022 updated by: Hackensack Meridian Health

Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19

This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. Following enrollment on the protocol and provision of informed consent, patients will be transfused with approximately 200-500 mL of ABO compatible convalescent plasma obtained from individuals who have recovered from documented infection with SARS-CoV-2 and who have been found to have high anti-SARS-CoV2 titers. Safety information collected will include serious adverse events judged to be related to the administration of convalescent plasma. Other information to be collected retrospectively will include patient demographics, resource utilization (total length of stay, days in ICU, days intubated, and survival to discharge from the facility.

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

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
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age at least 18 years
  2. Laboratory confirmed diagnosis of infection with SARS-CoV-2
  3. Admitted to the hospital for the treatment of COVID-19 complications
  4. Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease
  5. Informed consent provided by the patient or healthcare proxy

  6. Severe COVID-19 is defined by one or more of the following:

    • 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 COVID-19 is defined as one or more of the following:

  • respiratory failure/mechanical ventilation
  • septic shock
  • multiple organ dysfunction or 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?

Collaborators and Investigators

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

Sponsor

Hackensack Meridian Health

Investigators

  • Principal Investigator: Michele Donato, Hackensack Meridian Health

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 Registration Dates

First Submitted

July 14, 2020

First Submitted That Met QC Criteria

July 14, 2020

First Posted (Actual)

July 15, 2020

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 7, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2020-0663

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.

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