COVID-19
Conditions
Keywords
convalescent plasma
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.
Interventions
BIOLOGICALCCP
Randomized open label study to receive 2:1 CCP to standard of care
Sponsors
Metro Infectious Disease Consultants
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Outpatient open label randomized study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Resolution of Symptoms | 28 days | a. Time to resolution of symptoms will be defined as time from randomization (day 0) to a successful outcome. c. A successful outcome is defined as symptom improvement of 3 numbers or down to zero on the memory aid for all symptoms noted. |
| SAEs within 24 hours of plasma infusion | 28 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization within 28 days | 28 days | — |
| Decrease in Inflammatory Markers | 28 days | A 50% decrease at day 28 in C-Reactive Protein (mg/mL) |
Countries
United States
Outcome results
None listed