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OpenTrials
Completed

NCT Number: NCT04344015

COVID-19 Plasma Collection

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasma Donation

Other

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

Primary outcomes

  1. Number of patients who screen eligible for donation

    Time frame: 1 year

    # of individuals screened eligible

  2. Number of patients who consent to plasma donation

    Time frame: 1 year

    # of patients who consent to donation

  3. Number of plasma donations received

    Time frame: 1 year

    # of plasma donations received

Secondary outcomes

  1. Safety of donation procedures

    Time frame: 1 year

    Side effects or adverse events related to plasma donation

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

Collection of COVID-19 Convalescent Plasma

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2020
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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