Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection

September 15, 2023 updated by: Hackensack Meridian Health

Phase IIa Study Exploring the Safety and Efficacy of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Hospitalized Subjects With COVID-19 Infection

  • This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection.
  • Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first.
  • Interim analysis will be permitted as described in the statistical section 8.
  • The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Overall study design

  • This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection.
  • Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first.
  • Interim analysis will be permitted as described in the statistical section 8.
  • The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study.

Number of subjects

• Up to 36 patients in track 2, and 19 patients in track 3 as described in the statistical section 8.

Overall study duration

  • The study begins when the first subject (this will likely be a donor) signs the informed consent. The study will end once the last enrolled subject completes the study (likely a recipient).
  • The expected duration of the study is approximately 12 months.

Study Type

Interventional

Enrollment (Actual)

52

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
    • 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

No

Description

Donor Eligibility Criteria:

  • Age 18-60
  • A history of a positive nasopharyngeal swab for COVID-19 or a history of positive titer test.
  • At least 14 days from resolution of COVID-19-associated symptoms including fevers
  • One negative nasopharyngeal swabs for COVID-19 RNA
  • Covid-19 neutralizing antibody >1:64
  • Adequate venous access for apheresis
  • Meets donor eligibility criteria in accordance to Hackensack University Medical Center (HUMC) Collection Facility at the John Theurer Cancer Center (JTCC) if collecting at the JTCC, and all regulatory agencies as describes in SOP 800 01 (Appendix A)
  • Required testing of the donor and product must be performed in accordance to FDA regulations (21 CFR 610.40), and the donation must be found suitable (21 CFR 630.30)

Recipient Eligibility Criteria:

Recipients age >18 years old, are assigned to one of two clinical tracks, track 2 or 3, based on COVID-19 disease severity. Onset of first symptoms < 9 days.

Track 2:

  • Hospitalized, moderate symptoms requiring medical care for COVID-19 infection
  • Symptoms may include fever, dyspnea, dehydration among others
  • Hypoxemia may be present but is not a requirement

Track 3:

  • Requiring mechanical ventilation for the care of COVID-19 infection
  • Requiring non-invasive positive pressure ventilation (NIPPV), such as continuous airway pressure (CPAP),bi-level positive airway pressure (BiPAP) or high flow nasal canula (HFNC).

Recipient exclusion criteria:

  • History of severe transfusion reaction to plasma products
  • Infusion of immune globulin within the previous 30 days
  • AST or ALT > 10 x upper limit of normal
  • Requirement for vasopressors
  • COVID-19-associated acute kidney injury requiring dialysis
  • DNR status

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: Convalescent Plasma
Fresh or frozen plasma will be infused one time to patients
Biological: Convalescent Plasma
Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Hospitalized for COVID-19 But Not Intubated
Time Frame: 7 Days
Mechanical ventilation rate at 7 days from starting treatment in hospitalized COVID-19 patients
7 Days
Primary Objective for Patients With COVID-19 Already Intubated
Time Frame: 30 Days
Mortality rate at 30 days from starting treatment for patients with COVID-19
30 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Hospitalization
Time Frame: 60 Days
The duration of hospitalization is defined as the time in days from the first day of hospitalized to the date of discharge or death. Patients who are not discharged, are alive and still in the hospital on the date of closing follow-up, or lost follow-up on the date of closing follow-up will be considered censored on that date.
60 Days
Duration of Mechanical Ventilation
Time Frame: 60 Days
The duration of mechanical ventilation is defined as the time in days from the first day of using mechanical ventilation to the last day of using mechanical ventilation. All evaluable patients will be included and no censoring for this analysis.
60 Days
Time to Symptoms Resolution
Time Frame: 60 Days
The time to symptom resolution is defined as the time in days from new therapy initiation to the first documented symptom resolution as assessed by local site. Patients whose symptom are not resolved, who are dead, or lost follow-up on the designed follow-up date will be censored on that date.
60 Days
Overall Survival
Time Frame: 60 Days
Overall survival rate at 60 days from starting treatment for patients with COVID-19
60 Days
Rate of Virologic Clearance by Nasopharyngeal Swab at Day 10
Time Frame: 10 Days
10 Days
Rate of Virologic Clearance by Nasopharyngeal Swab at Day 30
Time Frame: 30 Days
30 Days
Impact of Donor Titers Level on Efficacy
Time Frame: 60 Days
60 Days
Impact of Donor Titers Level on Safety
Time Frame: 60 Days
60 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Days 0 (Pre-infusion)
Time Frame: 0 Days (pre-infusion)
0 Days (pre-infusion)
Recipient Anti-SARS-CoV2 Titer Assessment on Days 3
Time Frame: 3 Days
3 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Day 10
Time Frame: 10 Days
10 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Day 30
Time Frame: 30 Days
30 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Day 60
Time Frame: 60 Days
60 Days

Collaborators and Investigators

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

Sponsor

Hackensack Meridian Health

Investigators

  • Principal Investigator: Michele L Donato, MD, 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 Major Dates

Study Start (Actual)

April 9, 2020

Primary Completion (Actual)

April 26, 2023

Study Completion (Actual)

April 26, 2023

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 9, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2020-0375

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.

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