COVID-19 Plasma Collection

• Sponsor: Thomas Jefferson University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04344015
• Collaborator: (none)
• Enrollment: 206
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.6
• Patients Per Site Per Month: 125.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Other: Plasma Donation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 206 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Collection of COVID-19 Convalescent Plasma
• Actual Study Start Date: Apr 13, 2020
• Actual Primary Completion Date: Jun 2, 2020
• Actual Study Completion Date: Jun 2, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Number of patients who screen eligible for donation [1 year]

   # of individuals screened eligible

2. Number of patients who consent to plasma donation [1 year]

   # of patients who consent to donation

3. Number of plasma donations received [1 year]

   # of plasma donations received

Secondary Outcome Measures

1. Safety of donation procedures [1 year]

   Side effects or adverse events related to plasma donation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Thomas Jefferson University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas Jefferson University
• ClinicalTrials.gov Identifier: NCT04344015
• Other Study ID Numbers: 20D.346
• First Posted: Apr 14, 2020
• Last Update Posted: May 10, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of May 10, 2021