Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection
Study Details
Study Description
Brief Summary
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This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection.
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Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first.
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Interim analysis will be permitted as described in the statistical section 8.
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The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Detailed Description
Overall study design
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This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection.
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Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first.
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Interim analysis will be permitted as described in the statistical section 8.
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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
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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).
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The expected duration of the study is approximately 12 months.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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
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Outcome Measures
Primary Outcome Measures
- For patients hospitalized for COVID-19 but not intubated [7 Days]
Mechanical ventilation rate at 7 days from starting treatment in hospitalized COVID-19 patients
- Primary objective for patients with COVID-19 already intubated [30 Days]
Mortality rate at 30 days from starting treatment for patients with COVID-19
Secondary Outcome Measures
- Duration of hospitalization [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.
- Duration of mechanical ventilation [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.
- Time to symptoms resolution [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.
- Overall survival [60 Days]
Overall survival will be defined as the time in days from study entry to death. Patients who are alive on the date of closing follow-up will be censored on that date.
- Rate of virologic clearance by nasopharyngeal swab at day 10 [60 Days]
- Impact of donor titers level on efficacy [60 Days]
- Impact of donor titers level on safety [60 Days]
- Recipient Anti-SARS-CoV2 titer assessment on days 0 (pre-infusion),3,10,30, 60 [0, 3, 10, 30, and 60 Days]
Eligibility Criteria
Criteria
Donor Eligibility Criteria:
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Age 18-60
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A history of a positive nasopharyngeal swab for COVID-19 or a history of positive titer test.
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At least 14 days from resolution of COVID-19-associated symptoms including fevers
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One negative nasopharyngeal swabs for COVID-19 RNA
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Covid-19 neutralizing antibody >1:64
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Adequate venous access for apheresis
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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)
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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:
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Hospitalized, moderate symptoms requiring medical care for COVID-19 infection
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Symptoms may include fever, dyspnea, dehydration among others
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Hypoxemia may be present but is not a requirement
Track 3:
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Requiring mechanical ventilation for the care of COVID-19 infection
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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:
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History of severe transfusion reaction to plasma products
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Infusion of immune globulin within the previous 30 days
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AST or ALT > 10 x upper limit of normal
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Requirement for vasopressors
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COVID-19-associated acute kidney injury requiring dialysis
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DNR status
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
Sponsors and Collaborators
- Hackensack Meridian Health
Investigators
- Principal Investigator: Michele L Donato, MD, Hackensack Meridian Health
Study Documents (Full-Text)
None provided.More Information
Publications
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- Pro2020-0375