Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19

Completed · Phase 2

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04438057

Run by

Metro Infectious Disease Consultants

People needed

103

Starts

2020-08-12

Expected to finish

2021-08-12

Last updated by the study team

2022-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Metro Infectious Disease Consultants — Burr Ridge, Illinois, United States

Full record on ClinicalTrials.gov

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