Expanded Access to Convalescent Plasma to Treat and Prevent Pulmonary Complications Associated With COVID-19

March 4, 2021 updated by: Nakhle Saba, MD

Convalescent Plasma to Treat and Prevent Pulmonary Complications Associated With COVID-19

I. Study Design: This is a single-arm feasibility study to assess the safety and efficacy of anti-SARS-CoV-2 convalescent plasma (CP) in

  1. intubated, mechanically ventilated patients with confirmed COVID-19 pneumonia by chest X-ray or chest CT.
  2. hospitalized patients with acute respiratory symptoms between 3 and 7 days after the onset of symptoms, with COVID-19.

II. Study Population:

  1. Population 1: Mechanically ventilated intubated COVID-19 patients aged 18 years or older.
  2. Population 2: Hospitalized COVID-19 patients aged ≥18 years of age with respiratory symptoms within 3 to 7 days from the beginning of illness.

III. Study Agent:

SARS-CoV-2 convalescent plasma (1-2 units; ~200-400 mL at neutralization antibody titer >1:160.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

There are currently no proven safe and efficacious treatment for COVID-19. While most patients recover on their own with basic measures at home, around 20% suffer a more aggressive disease requiring hospitalization, of which 5% necessitating intensive care unit (ICU) admission and potential invasive breathing support. The wide spectrum of COVID 19 also include a significant number of totally asymptomatic patients who are unknowingly spreading the disease. Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma. This convalescent plasma could be beneficial, not only for severely ill and intubated patients, but also for those with moderate disease early in their disease course to prevent further disease progression and ICU admission.

I. Study Design: This is a single-arm feasibility study to assess the safety and efficacy of anti-SARS-CoV-2 convalescent plasma (CP) in

  1. intubated, mechanically ventilated patients with confirmed COVID-19 pneumonia by chest X-ray or chest CT.
  2. hospitalized patients with acute respiratory symptoms between 3 and 7 days after the onset of symptoms, with COVID-19.

II. Study Population:

  1. Population 1: Mechanically ventilated intubated COVID-19 patients aged 18 years or older.
  2. Population 2: Hospitalized COVID-19 patients aged ≥18 years of age with respiratory symptoms within 3 to 7 days from the beginning of illness.

III. Study Duration: April 3, 2020 to December 31, 2022.

IV. Study Agent:

SARS-CoV-2 convalescent plasma (1-2 units; ~200-400 mL at neutralization antibody titer >1:160. (Note this is a moving target as assays develop)). Product will be produced using Blood Bank of New Orleans and safety procedures and procured from patients who have been symptom free for 14 days and screen negative via NP swab or any other test that emerges in the meantime. Doors who have been symptoms free for more than 28 days are eligible to donate without the need of a NP swab. Any emerging FDA guidance will be followed.

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population
  • 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
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane 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:

Population 1: Associated Severe Pulmonary Complications

  • 18 years or older.
  • Hospitalized and intubated in the ICU with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. Patient or proxy is willing and able to provide written informed consent and comply with all protocol requirements, or requirement for informed consent is WAIVED due to the inability to communicate with the patient and unable to identify legally authorized representative.
  • Consents to storage of specimens for future testing, or consent waived.
  • The requirements to waive a consent are delineated in 21 CFR 50.23 and will be followed.
  • Pregnant and breastfeeding women will not be excluded from the study.

Population 2: Coronavirus Associated Complications in hospitalized patients

  • Patients must be 18 years of age or older.
  • Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. Patient is willing and able to provide written informed consent and comply with all protocol requirements.
  • Patient agrees to storage of specimens for future testing.

Exclusion Criteria:

Population 1:

  • Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
  • Severe multi-organ failure with expected life expectancy < 24h as determined by the treating physician.

Population 2:

  • Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
  • Receipt of pooled immunoglobulin in past 30 days.
  • Contraindication to transfusion or history of prior reactions to transfusion blood products.

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

Nakhle Saba, MD

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

April 17, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (ACTUAL)

April 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-595

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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