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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
103
Randomized open label study to receive 2:1 CCP to standard of care
Metro Infectious Disease Consultants
Burr Ridge, Illinois, United States
Time to Resolution of Symptoms
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.
Time frame: 28 days
SAEs within 24 hours of plasma infusion
Time frame: 28 days
Decrease in Inflammatory Markers
A 50% decrease at day 28 in C-Reactive Protein (mg/mL)
Time frame: 28 days
Decrease in Inflammatory Markers
A 50% decrease at day 28 in D-Dimer (ng/mL)
Time frame: 28 days
Decrease in Inflammatory Markers
A 50% decrease at day 28 in Ferritin (ng/mL)
Time frame: 28 days
Decrease in Inflammatory Markers
A 50% decrease at day 28 in Lactate Dehydrogenase (U/L)
Time frame: 28 days
Hospitalization within 28 days
Time frame: 28 days
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