Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection
NCT ID: NCT04456413
Last Updated: 2023-10-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
21 participants
INTERVENTIONAL
2020-11-06
2021-05-04
Brief Summary
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* 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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Convalescent Plasma
Fresh or frozen plasma will be infused one time to patients
Convalescent Plasma
Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
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.
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.
Interventions
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Convalescent Plasma
Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
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.
Eligibility Criteria
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Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Hackensack Meridian Health
OTHER
Responsible Party
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Principal Investigators
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Michele L Donato, MD
Role: PRINCIPAL_INVESTIGATOR
Hackensack Meridian Health
Locations
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Hackensack University Medical Center
Hackensack, New Jersey, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Pro2020-0542
Identifier Type: -
Identifier Source: org_study_id
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