COVID-19 Plasma Collection

COVID-19 Clinical Trial

Official title:

Collection of COVID-19 Convalescent Plasma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04344015
• Other study ID #: 20D.346
• Status: Completed
• Phase: N/A
• Start date: April 13, 2020
• Est. completion date: June 2, 2020

Study information

• Verified date: May 2021
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: June 2, 2020
• Est. primary completion date: June 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who screen eligible for donation	# of individuals screened eligible	1 year
Primary	Number of patients who consent to plasma donation	# of patients who consent to donation	1 year
Primary	Number of plasma donations received	# of plasma donations received	1 year
Secondary	Safety of donation procedures	Side effects or adverse events related to plasma donation	1 year