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Virus Therapy
Convalescent Plasma for Coronavirus
Phase 2
Recruiting
Led By Joseph M Flynn, DO, MPH
Research Sponsored by Joseph M. Flynn, D.O., MPH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 30 days
Awards & highlights
Study Summary
This study is evaluating whether the transfer of white blood cells from individuals who are immune to SARS, a common virus, may help treat SARS.
Eligible Conditions
- Coronavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the therapeutic efficacy (response rate) of convalescent plasma infusion in patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19).
Secondary outcome measures
Absolute lymphocyte count (10*3/uL)
C-reactive protein (mg/dl)
D-Dimer (ng/ml FEU)
+4 moreSide effects data
From 2021 Phase 3 trial • 511 Patients • NCT0435576712%
Pneumonia
4%
Infusion related reaction
2%
Dyspnea
2%
Hypoxia
1%
Fatigue
1%
Pulmonary embolism
1%
Chest pain
1%
Flank pain
1%
Migraine
1%
Dehydration
1%
Acute respiratory failure
1%
Vomiting
1%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Convalescent Plasma
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
Study is single arm all patients hospitalized meeting inclusion/exclusion criteria and providing informed consent to receive one unit (approximately 200 mL) of convalescent plasma with data collected daily on routine (non-research) clinical assessments/physical exams and lab results.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
COVID-19 convalescent plasma
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Joseph M. Flynn, D.O., MPHLead Sponsor
Joseph M Flynn, DO, MPHPrincipal InvestigatorNorton Healthcare
Frequently Asked Questions
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