Clinical trial NCT04554992: Convalescent Plasma for the Treatment of COVID-19 (Coronavirus Disease 2019)
Official title: Convalescent Plasma for the Treatment of Coronavirus Disease 2019
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Covid19
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative incidence of serious adverse events related to the treatment intervention.
timeFrame: up to 60 days post-transfusion
measure: Mortality at Day 28 post-hospital admission.
timeFrame: up to 28 days post-transfusion
Secondary outcomes:
measure: Length of hospital stay
timeFrame: up to 60 days post-transfusion
measure: Length of supplemental oxygen requirement.
timeFrame: up to 60 days post-transfusion
measure: Length of mechanical ventilation requirement.
timeFrame: up to 60 days post-transfusion
measure: Length of ICU stay
timeFrame: up to 60 days post-transfusion
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hopsital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Eric Salazar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: