Status:
COMPLETED
Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19
Lead Sponsor:
Metro Infectious Disease Consultants
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will provide investigational convalescent plasma for patients infected with the SARS-CoV-2 with mild to moderate symptoms who meet inclusion criteria as judged by physician evaluation.
Detailed Description
This study will provide investigational convalescent plasma for patients infected with the SARS-CoV-2 with mild to moderate symptoms who meet inclusion criteria as judged by physician evaluation. Fol...
Eligibility Criteria
Inclusion
- Laboratory confirmed diagnosis of infection with SARS-CoV-2
- Symptoms of COVID -19 - cough, fever, sore throat, SOB, anosmia, diarrhea, myalgia
- Symptoms less than 14 days
- ID Physician determination that the patient does not need hospitalization
- O2 saturation of \>93%
- Informed consent provided by the patient or healthcare proxy
- Age ≥ 18 years
- Ambulatory Outpatient when informed consent obtained and study drug is administered
Exclusion
- Age \< 18 y/o
- Patients currently receiving intravenous immunoglobulin
- Hypercoagulable state - neoplasia, Collagen vascular disease, Myelodysplastic syndrome, chronic anticoagulation treatment, etc.
- Need to be hospitalized
- O2 sat \< 93%
- D-Dimer \> 2x normal
- Chronic oxygen therapy
- Renal insufficiency with Creatinine clearance \< 30
- Long term care or assisted living facility resident
- Ongoing usage of hydroxychloroquine for any indication
- History of blood or plasma transfusion related complications
- Enrollment into any other investigational drug or device study within the previous 30 days
- Any drug, chemical or alcohol dependency as determined by the investigator through history that may affect study procedures and follow up
- Pregnant or breast feeding
- Any acute or chronic medical comorbidity, psychiatric, social or other circumstance that, in the opinion of the investigator, may interfere with study compliance, completion, or accurate assessment of the study outcomes/safety
- Admitted to or expected to be admitted to a medical facility
Key Trial Info
Start Date :
August 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2021
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT04438057
Start Date
August 12 2020
End Date
August 12 2021
Last Update
April 6 2022
Active Locations (1)
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1
Metro Infectious Disease Consultants
Burr Ridge, Illinois, United States, 60527