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

Primary Purpose

COVID-19

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Convalescent Plasma
Sponsored by
Hackensack Meridian Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Coronavirus, Covid19, SARS-CoV-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hackensack University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Convalescent Plasma

Arm Description

Fresh or frozen plasma will be infused one time to patients

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of Hospitalization
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.
Duration of Mechanical Ventilation
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.
Time to Symptoms Resolution
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.
Overall Survival
Overall survival rate at 60 days from starting treatment for patients with COVID-19
Rate of Virologic Clearance by Nasopharyngeal Swab at Day 10
Rate of Virologic Clearance by Nasopharyngeal Swab at Day 30
Impact of Donor Titers Level on Efficacy
Impact of Donor Titers Level on Safety
Recipient Anti-SARS-CoV2 Titer Assessment on Days 0 (Pre-infusion)
Recipient Anti-SARS-CoV2 Titer Assessment on Days 3
Recipient Anti-SARS-CoV2 Titer Assessment on Day 10
Recipient Anti-SARS-CoV2 Titer Assessment on Day 30
Recipient Anti-SARS-CoV2 Titer Assessment on Day 60

Full Information

First Posted
April 8, 2020
Last Updated
September 15, 2023
Sponsor
Hackensack Meridian Health
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1. Study Identification

Unique Protocol Identification Number
NCT04343755
Brief Title
Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Lack of eligible patients due to change in standard therapy
Study Start Date
April 9, 2020 (Actual)
Primary Completion Date
April 26, 2023 (Actual)
Study Completion Date
April 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hackensack Meridian Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Coronavirus, Covid19, SARS-CoV-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Convalescent Plasma
Arm Type
Experimental
Arm Description
Fresh or frozen plasma will be infused one time to patients
Intervention Type
Biological
Intervention Name(s)
Convalescent Plasma
Intervention Description
Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
Primary Outcome Measure Information:
Title
Number of Participants Hospitalized for COVID-19 But Not Intubated
Description
Mechanical ventilation rate at 7 days from starting treatment in hospitalized COVID-19 patients
Time Frame
7 Days
Title
Primary Objective for Patients With COVID-19 Already Intubated
Description
Mortality rate at 30 days from starting treatment for patients with COVID-19
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Duration of Hospitalization
Description
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.
Time Frame
60 Days
Title
Duration of Mechanical Ventilation
Description
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.
Time Frame
60 Days
Title
Time to Symptoms Resolution
Description
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.
Time Frame
60 Days
Title
Overall Survival
Description
Overall survival rate at 60 days from starting treatment for patients with COVID-19
Time Frame
60 Days
Title
Rate of Virologic Clearance by Nasopharyngeal Swab at Day 10
Time Frame
10 Days
Title
Rate of Virologic Clearance by Nasopharyngeal Swab at Day 30
Time Frame
30 Days
Title
Impact of Donor Titers Level on Efficacy
Time Frame
60 Days
Title
Impact of Donor Titers Level on Safety
Time Frame
60 Days
Title
Recipient Anti-SARS-CoV2 Titer Assessment on Days 0 (Pre-infusion)
Time Frame
0 Days (pre-infusion)
Title
Recipient Anti-SARS-CoV2 Titer Assessment on Days 3
Time Frame
3 Days
Title
Recipient Anti-SARS-CoV2 Titer Assessment on Day 10
Time Frame
10 Days
Title
Recipient Anti-SARS-CoV2 Titer Assessment on Day 30
Time Frame
30 Days
Title
Recipient Anti-SARS-CoV2 Titer Assessment on Day 60
Time Frame
60 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele L Donato, MD
Organizational Affiliation
Hackensack Meridian Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection

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