* This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection. * Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first. * Interim analysis will be permitted as described in the statistical section 8. * The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study.
Overall study design * This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection. * Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first. * Interim analysis will be permitted as described in the statistical section 8. * The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study. Number of subjects • Up to 36 patients in track 2, and 19 patients in track 3 as described in the statistical section 8. Overall study duration * The study begins when the first subject (this will likely be a donor) signs the informed consent. The study will end once the last enrolled subject completes the study (likely a recipient). * The expected duration of the study is approximately 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
Hackensack University Medical Center
Hackensack, New Jersey, United States
Number of Participants Hospitalized for COVID-19 But Not Intubated
Mechanical ventilation rate at 7 days from starting treatment in hospitalized COVID-19 patients
Time frame: 7 Days
Primary Objective for Patients With COVID-19 Already Intubated
Mortality rate at 30 days from starting treatment for patients with COVID-19
Time frame: 30 Days
Duration of Hospitalization
The duration of hospitalization is defined as the time in days from the first day of hospitalized to the date of discharge or death. Patients who are not discharged, are alive and still in the hospital on the date of closing follow-up, or lost follow-up on the date of closing follow-up will be considered censored on that date.
Time frame: 60 Days
Duration of Mechanical Ventilation
The duration of mechanical ventilation is defined as the time in days from the first day of using mechanical ventilation to the last day of using mechanical ventilation. All evaluable patients will be included and no censoring for this analysis.
Time frame: 60 Days
Time to Symptoms Resolution
The time to symptom resolution is defined as the time in days from new therapy initiation to the first documented symptom resolution as assessed by local site. Patients whose symptom are not resolved, who are dead, or lost follow-up on the designed follow-up date will be censored on that date.
Time frame: 60 Days
Overall Survival
Overall survival rate at 60 days from starting treatment for patients with COVID-19
Time frame: 60 Days
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Rate of Virologic Clearance by Nasopharyngeal Swab at Day 10
Time frame: 10 Days
Rate of Virologic Clearance by Nasopharyngeal Swab at Day 30
Time frame: 30 Days
Impact of Donor Titers Level on Efficacy
Time frame: 60 Days
Impact of Donor Titers Level on Safety
Time frame: 60 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Days 0 (Pre-infusion)
Time frame: 0 Days (pre-infusion)
Recipient Anti-SARS-CoV2 Titer Assessment on Days 3
Time frame: 3 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Day 10
Time frame: 10 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Day 30
Time frame: 30 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Day 60
Time frame: 60 Days