Clinical trial NCT04343755: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Keywords: Coronavirus
Covid19
SARS-CoV-2
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants Hospitalized for COVID-19 But Not Intubated
timeFrame: 7 Days
measure: Primary Objective for Patients With COVID-19 Already Intubated
timeFrame: 30 Days
Secondary outcomes:
measure: Duration of Hospitalization
timeFrame: 60 Days
measure: Duration of Mechanical Ventilation
timeFrame: 60 Days
measure: Time to Symptoms Resolution
timeFrame: 60 Days
measure: Overall Survival
timeFrame: 60 Days
measure: Rate of Virologic Clearance by Nasopharyngeal Swab at Day 10
timeFrame: 10 Days
measure: Rate of Virologic Clearance by Nasopharyngeal Swab at Day 30
timeFrame: 30 Days
measure: Impact of Donor Titers Level on Efficacy
timeFrame: 60 Days
measure: Impact of Donor Titers Level on Safety
timeFrame: 60 Days
measure: Recipient Anti-SARS-CoV2 Titer Assessment on Days 0 (Pre-infusion)
timeFrame: 0 Days (pre-infusion)
measure: Recipient Anti-SARS-CoV2 Titer Assessment on Days 3
timeFrame: 3 Days
measure: Recipient Anti-SARS-CoV2 Titer Assessment on Day 10
timeFrame: 10 Days
measure: Recipient Anti-SARS-CoV2 Titer Assessment on Day 30
timeFrame: 30 Days
measure: Recipient Anti-SARS-CoV2 Titer Assessment on Day 60
timeFrame: 60 Days
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Michele L Donato, MD
role: PRINCIPAL_INVESTIGATOR
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