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

September 15, 2023 updated by: Hackensack Meridian Health

Phase II Randomized Study of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Subjects With Early COVID-19 Infection

  • This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications.
  • Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first.
  • Subjects will be randomized to receiving convalescent plasma or best supportive care.
  • Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease.
  • The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Overall study design

  • This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications.
  • Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first.
  • Subjects will be randomized to receiving convalescent plasma or best supportive care.
  • Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease.
  • The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.

A total of 306 subjects will be recruited, 153 for each arm. If a patient in the best supportive care arm requires hospitalization, the patient will be eligible to receive convalescent plasma if requested and/or deemed medically appropriate by the admitting physician.

Overall study duration

  • The study begins when the first subject (donor or recipient) 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)

21

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 antibody titer test.
  • At least 14 days from resolution of COVID-19-associated symptoms including fevers.
  • A negative nasopharyngeal swab (or similar test) for COVID-19
  • anti-SARS-CoV2 titers >1:500
  • 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.
  • 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:

  • Patient age >30 years old, newly diagnosed with a COVID-19 infection with onset of first symptoms < 96 hours.

  • And least one other high-risk feature:

    1. Age > 65
    2. BMI 30 or above
    3. Hypertension, defined as SBP above 140 or DBP above 90, or requiring medication for control.
    4. Coronary artery disease (history, not ECG changes only)
    5. Congestive heart failure
    6. Peripheral vascular disease (includes aortic aneurysm >= 6 cm)
    7. Cerebrovascular disease (history of CVA or TIA)
    8. Dementia
    9. Chronic pulmonary disease
    10. Liver disease (such as portal hypertension, chronic hepatitis)
    11. Diabetes (excludes diet-controlled alone)
    12. Moderate or severe renal disease defined as having a GFR < 60 mL/min
    13. Cancer (exclude if > 5 year in remission)
    14. AIDS (not just HIV positive)

Recipient exclusion criteria:

  • History of severe transfusion reaction to plasma products
  • Need for oxygen supplementation
  • Positive test for COVID-19 antibodies
  • Chemotherapy-induced neutropenia (ANC < 0.5 x 103/mcL)
  • Immunosuppressive medications except for prednisone (or steroid equivalent) > 10 mg daily.
  • Performance status < 50 by KPS
  • Pneumonia by radiographic evaluation

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: Randomized
  • Interventional Model: Crossover 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
Active Comparator: Best Supportive Care
Patients will receive best supportive care. Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease.
Other: Best Supportive Care
Patients will receive best supportive care. Patients randomized to this arm may receive plasma should they require hospitalization for progression of COVID-19 disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization Rate
Time Frame: 10 Days
The hospitalization rate will be summarized by frequency (%) and compared between the Treatment and Control arms by Mantel-Haenszel test.
10 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Symptoms Resolution
Time Frame: 2 Months
The time to symptoms resolution is defined as the time in days from therapies initiation to the first documented symptoms resolution as assessed by a local site. Patients whose symptoms are not resolved, or result in death, or lost follow-up on the designed follow-up date, will be censored on that date.
2 Months
Rate of Nasopharyngeal Swab Positivity in Donors
Time Frame: 2 Months
2 Months
Impact of Donor Titers Level on Efficacy
Time Frame: 2 Months
2 Months
Patients' Anti-SARS-CoV2 Titer Assessment Pre-infusion for the Treatment Group, at 2 Weeks , 4 Weeks and 2 Months.
Time Frame: Prior to treatment, 2 Weeks, 4 Weeks, and 2 Months
Prior to treatment, 2 Weeks, 4 Weeks, and 2 Months
Overall Survival Rate
Time Frame: 2 Months
Overall survival (OS) will be defined as Rate of death
2 Months
Rate of Virologic Clearance by Nasopharyngeal Swab at 2 Weeks
Time Frame: 2 Weeks
2 Weeks
Rate of Donor Titers Level
Time Frame: 2 Months
Rate of Donor Titer Levels >1:1000
2 Months
Rate of Virologic Clearance by Nasopharyngeal Swab at 4 Weeks
Time Frame: 4 Weeks
4 Weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Product's Cytokine Level Assessment
Time Frame: Day 0
Univariate test will be performed in terms of identifying the association between exploratory objective and the hospitalization rate, Mantel-Haenszel test for categorical variables, and t-test or its non-parametric version for the continuous variables based on the normalized of the data.
Day 0
Plasma Product's Mannose-binding Lectin (MBL) Level Assessment
Time Frame: Day 0
Day 0
Plasma Product's Procalcitonin (PCT) Level Assessment
Time Frame: Day 0
Day 0
Plasma Product's C-reactive Protein (CRP) Level Assessment
Time Frame: Day 0
Day 0
Plasma Product's Human Neutrophil Lipocalin (HNL) Level Assessment
Time Frame: Day 0
Day 0
Plasma Product's Annexin V Level Assessment
Time Frame: Day 0
Day 0
Plasma Product's Surfactant Protein D (SP-D) Level Assessment
Time Frame: Day 0
Day 0
Plasma Product's microRNA Level Assessment
Time Frame: Day 0
Day 0
Plasma Product's Immunoglobulin Level Assessment
Time Frame: Day 0
Day 0
Patients' Cytokines Levels Assessment at +2 and +4 Weeks Post Randomization
Time Frame: 2 Weeks and 4 Weeks
2 Weeks and 4 Weeks
Patients' Chemokines Levels Assessment at +2 and +4 Weeks Post Randomization
Time Frame: 2 Weeks and 4 Weeks
2 Weeks and 4 Weeks
Rates of Adverse Events Associated With Convalescent Plasma Infusion.
Time Frame: Day 3 and 7, Weeks 2 and 4
Safety assessment will be performed on infusion day for the Treatment group (immediately post infusion), and for all patients on randomization day +3 and +7 days (by telephone, closest business day is acceptable), +2 weeks (+/- 3 days), +4 weeks (+/- 3 days).
Day 3 and 7, Weeks 2 and 4

Collaborators and Investigators

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

Sponsor

Hackensack Meridian Health

Collaborators

United States Department of Defense

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)

November 6, 2020

Primary Completion (Actual)

April 29, 2021

Study Completion (Actual)

May 4, 2021

Study Registration Dates

First Submitted

June 30, 2020

First Submitted That Met QC Criteria

June 30, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

October 10, 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

  • Pro2020-0542

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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