COVID-19 Plasma Collection

NCT04344015 | Completed

• 1 other identifier: 20D.346
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Safety of donation procedures

  1 year

Study Arms (1)

Convalescent Plasma Donation

OTHER

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

Interventions

Plasma Donation OTHER

Previously infected COVID-19 patients will be recruited to donate convalescent plasma.

Convalescent Plasma Donation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Blood Donation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tissue and Organ Procurement; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 14, 2020
• Study Start: April 13, 2020
• Primary Completion: June 2, 2020
• Study Completion: June 2, 2020
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

US (1)