Clinical trial NCT04438057: Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19
Official title: Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: convalescent plasma
Lead sponsor: Metro Infectious Disease Consultants
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Outpatient open label randomized study
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Resolution of Symptoms
timeFrame: 28 days
measure: SAEs within 24 hours of plasma infusion
timeFrame: 28 days
Secondary outcomes:
measure: Decrease in Inflammatory Markers
timeFrame: 28 days
measure: Decrease in Inflammatory Markers
timeFrame: 28 days
measure: Decrease in Inflammatory Markers
timeFrame: 28 days
measure: Decrease in Inflammatory Markers
timeFrame: 28 days
measure: Hospitalization within 28 days
timeFrame: 28 days
Other outcomes:
Locations:
city: Burr Ridge
country: United States
facility: Metro Infectious Disease Consultants
state: Illinois
Study officials:
References: