Clinical trial NCT04344015: COVID-19 Plasma Collection
Official title: Collection of COVID-19 Convalescent Plasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Patients who are severely ill with COVID-19 may benefit from receiving plasma infusions from donors who have recovered from the disease and are proven to no longer be infected. Efforts to initiate the collection and infusion of these products to high risk patients have been initiated around the world and the FDA has recently provided information about how this could be accomplished. As the Jefferson Blood Donor Center already has processes to collect, test and process blood, investigators are planning to make efforts to collect plasma for this use should it be necessary. The purpose of this study is to describe the process for identifying and collecting convalescent plasma from donors previously infected with the virus. The research portion on top of this standard blood product collection will the process of identification of subjects and processes by which blood products are processed in this special population. This protocol does not involve the administration of blood products to patients with COVID-19 infection.

Detailed description: As described by the FDA on 3/24/2020, convalescent plasma has been used for a variety of infectious diseases including Ebola, SARS, MERS and H1N1 flu. Given that there is no current medical treatment beyond supportive care for COVID-19, there is a great deal of interest in using convalescent plasma for patients with COVID-19. As a first step in this process, investigators are proposing to identify donors and collect plasma with antibodies against COVID-19. While the intention is to use this for patients in the near future, the purpose of this study will be to see if this is feasible and a separate application will be submitted related to the treatment of patients with these products.

Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Prior diagnosis of COVID-19 documented by a laboratory test approved by the FDA
* Either: Complete resolution of all COVID-related symptoms for 14-28 days at the time of blood donation AND negative repeated SARS-CoV-2 test OR Complete resolution of all COVID-related symptoms for \> 28 days
* Male donors, never-pregnant female donors, or previously pregnant female donors negative for HLA antibodies
* Meet all criteria for volunteer blood donation per Jefferson Blood Donor Center and the FDA

Exclusion Criteria:

* Failure to pass standard volunteer blood donor screening criteria required by the Jefferson Blood Donor Center and the FDA
* Female donors with HLA antibodies (per FDA requirements for convalescent plasma donors)
* Inadequate venous access for phlebotomy
* Currently pregnant

Primary outcomes:
measure: Number of patients who screen eligible for donation
timeFrame: 1 year
measure: Number of patients who consent to plasma donation
timeFrame: 1 year
measure: Number of plasma donations received
timeFrame: 1 year
Secondary outcomes:
measure: Safety of donation procedures
timeFrame: 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References: