COVID-19 Plasma Collection

Collection of COVID-19 Convalescent Plasma

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Other: Plasma Donation

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.

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Convalescent Plasma Donation; The goal of this study is to identify individuals who have previously been infected with COVID-19 and collect plasma from those who meet inclusion criteria for convalescent plasma donation. This protocol will allow for the collection, manufacturing, and storage of convalescent plasma that may be administered to patients with COVID-19 in the near future. In addition, it allows for testing of SARS-COV-2 antibody titers in the plasma that has been collected to inform studies assessing outcomes for patients currently infected with COVID-19 who have received convalescent plasma infusions.

Other: Plasma Donation; Previously infected COVID-19 patients will be recruited to donate convalescent plasma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who screen eligible for donation	# of individuals screened eligible	1 year
Number of patients who consent to plasma donation	# of patients who consent to donation	1 year
Number of plasma donations received	# of plasma donations received	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of donation procedures	Side effects or adverse events related to plasma donation	1 year

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2020
• Primary Completion (Actual): June 2, 2020
• Study Completion (Actual): June 2, 2020

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 20D.346

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No