Covid19
Conditions
Brief summary
This pilot, prospective study will assess the safety and efficacy of COVID-19 convalescent plasma versus standard care as treatment for severe and/or critical COVID-19 (as defined in the inclusion criteria) in adults 18 years of age and older. A total of 350 eligible subjects will receive a transfusion of anti-SARS-CoV2 ( severe acute respiratory syndrome) convalescent plasma.
Detailed description
Patients meeting inclusion/exclusion criteria will be approached for study consent based on the time of hospital admission and the availability of an blood type compatible product. 300mL plasma units of COVID-19 convalescent patients will be utilized for transfusion. During a period of 14 days, the patient will be eligible to receive up to 10 units of plasma, to be completed with 4 hours as per institutional transfusion standard operating procedures. Transfusion by apheresis (plasma exchange) may be employed to reduce the risk of volume overload. The number of units to be used will be determined by the study team based on protocol inclusion and exclusion criteria, and clinical evaluation of the patient's severity and response. Subjects will be followed for at least 60 days or up to 3 months following initial transfusion for adverse event monitoring and data collection.
Interventions
BIOLOGICALCOVID 19 Convalescent Plasma
COVID 19 convalescent plasma is a blood product collected from donors who have recovered from a previous COVID 19 infection
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Given that this is a pilot study to evaluate the safety of treatment with convalescent COVID-19 plasma versus standard care in subjects with severe and/or critical COVID-19 between the cases and historical controls without predetermined data, a convenient sample size of 700 patients (350 per group) has been proposed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Recipient must meet criteria outlined in the recent Investigational COVID-19 Convalescent Plasma - Emergency INDs (investigational new drug) guidance (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds)
Exclusion criteria
1. History of prior severe reactions to transfusion of blood products with imputability of probable or definite as defined by Center of Disease Control National Healthcare Safety Network Hemovigilance Module \[see https://www.cdc.gov/nhsn/PDFs/Biovigilance/BV-HV-protocol-current.pdf\]. 2. Has underlying uncompensated and untreatable end stage disease. 3. Fluid overload or other condition that would contraindicate administration of plasma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of serious adverse events related to the treatment intervention. | up to 60 days post-transfusion | Total number of grade 3 and above throughout study period |
| Mortality at Day 28 post-hospital admission. | up to 28 days post-transfusion | All cause mortality at day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | up to 60 days post-transfusion | Total number of days subjects are hospitalized during study period |
| Length of supplemental oxygen requirement. | up to 60 days post-transfusion | Total number of days subjects requires supplemental oxygen during study period |
| Length of mechanical ventilation requirement. | up to 60 days post-transfusion | Total number of days subjects require mechanical ventilation during study period |
| Length of ICU stay | up to 60 days post-transfusion | Total number of days subject is subject stays in the ICU |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREric Salazar, MD, PhD
The Methodist Hospital Research Institute
Outcome results
None listed