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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 Criteria

  • 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Outpatient open label randomized study
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Standard of Care 		Patient will receive standard of care therapy.
Active Comparator
Treatment Arm 		Patient will receive convalescent plasma
  • Biological: CCP
    Randomized open label study to receive 2:1 CCP to standard of care
    Other names:
    • convalescent plasma

Recruiting Locations

More Details

NCT ID
NCT04438057
Status
Completed
Sponsor
Metro Infectious Disease Consultants

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. Following patient enrollment into the study, completion of informed consent and randomization, the patient will receive one unit of convalescent COVID plasma or standard of care. The plasma will be infused in an outpatient infusion center by highly trained and experienced staff. Vitalant will be providing the plasma as per their normal screening and distribution protocols. Patients will be monitored for safety during the infusion and per protocol following the infusion for a period of 28 days. Primary efficacy and safety endpoints will be statistically analyzed and compared between the two groups.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.