Plasma Collection From Convalescent and/or Immunized Donors for the Treatment of COVID-19

NCT04360278 | Completed

• 2 other identifiers: 20009220-CC-0092
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The Coronavirus disease 2019 (COVID-19) pandemic is a major public health issue. Researchers want to collect plasma from people who have recovered from COVID-19, and use this plasma to treat people who are sick with the disease. The plasma will have antibodies against the virus that causes COVID-19. Persons who have received a COVID-19 vaccine may also donate plasma that contains antibodies against the virus if they meet criteria according to the FDA. Objective: To collect plasma from people who have recovered from COVID-19 or have been vaccinated against the coronavirus that causes COVID-19, so that the plasma can be used to treat people with the disease. Eligibility: Adults ages 18 and older who have been diagnosed with, and have recovered from, COVID-19. Design: Participants will be screened with a physical exam, medical history, and blood sample. Their pulse, blood pressure, and temperature will be taken. Their height and weight will be recorded. Participants will donate plasma. It will be collected through whole blood donation or through apheresis. For whole blood donation, a needle will be placed in the participant s arm vein. Blood will be withdrawn. For apheresis, a needle will be placed in the participant s arm vein. Blood will be withdrawn. A machine will separate the plasma from the red cells. The plasma will be removed, and the rest of the cells will be returned to the participant either through the same needle or through a needle in their other arm. Participants will have 3 to 20 plasma donations. Participation will last up to 3 years.

Conditions

COVID-19

Keywords

Titer; Antibodies; Natural History

Outcome Measures

Primary Outcomes (1)

• Collection of convalescent plasma

  Successful collection of convalescent or immunized donor plasma.

  240 days

Study Arms (1)

Plasma Donors

Persons who have recovered from COVID-19 or have been immunized against SARS-CoV-2 who meet criteria to donate plasma.

Eligibility Criteria

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

Study Population

Community donors who have recovered from COVID-19, or have been immunized against SARS-CoV-2.

You may qualify if:

• Ability of subject to understand, ask questions, and the willingness to sign the written informed consent document
• Age \>=18 years
• Ability to meet blood donor eligibility criteria as defined in the FDA Code of Federal Regulations 21 CFR 630, AABB Standards and DTM SOP, including:
• Weight \>=110 pounds (50 kg)
• Adequate peripheral venous access for plasma donation (as judged by the examiner)
• Vital signs (with exceptions as acceptable per DTM SOP)
• For COVID-19 convalescent subjects, the following criteria must be met:
• Prior diagnosis of COVID-19 documented by a laboratory test or by physician attestation
• Complete resolution of symptoms for at least 10 days prior to donation.
• Donors with residual loss of taste/smell are acceptable as long as they have no acute symptoms of COVID-19
• For vaccinated subjects, the following criteria must be met:
• Subjects must meet FDA donor eligibility criteria to donate convalescent plasma
• Willingness to engage in repeat plasma collections for a 120-day period with possible extension per FDA guidance, provided anti-SARS-CoV-2 titers remain sufficiently high
• Willingness to have samples stored for clinical and/or genetic research testing

You may not qualify if:

• Patients who cannot give proper informed consent due to inability to understand the nature of the proposed therapy and attendant risk
• Age under 18 years
• Females must not be pregnant (per routine blood donor criteria)
• Any sign of active infection, including but not limited to:
• Subjective or documented fever (\>37.5 (Infinite)C)
• Cough
• Shortness of breath
• Diarrhea
• Antibiotics within the prior 48 hours
• Considered immune suppressed for example current use of oral or parenteral steroids, highdose inhaled steroids (\>800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs
• Permanent deferral from blood donation as defined in the FDA Code of Federal Regulations 21 CFR 630, AABB Standards, and DTM SOP
• Participation in medical research outside DTM that includes:
• Protocols that are currently ongoing or will start during the duration of this study that require more than 500 mL of blood to be given in any 8-week period of time
• Total plasma protein level \< 6.0 g/dL
• Unwillingness to engage in repeat plasma collections for a 120-day period with possible extension per FDA guidance, provided anti-SARS-CoV-2 titers remain sufficiently high

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• Gedda MR, Danaher P, Shao L, Ongkeko M, Chen L, Dinh A, Thioye Sall M, Reddy OL, Bailey C, Wahba A, Dzekunova I, Somerville R, De Giorgi V, Jin P, West K, Panch SR, Stroncek DF. Longitudinal transcriptional analysis of peripheral blood leukocytes in COVID-19 convalescent donors. J Transl Med. 2022 Dec 12;20(1):587. doi: 10.1186/s12967-022-03751-7.

  PMID: 36510222 DERIVED

• De Giorgi V, West KA, Henning AN, Chen LN, Holbrook MR, Gross R, Liang J, Postnikova E, Trenbeath J, Pogue S, Scinto T, Alter HJ, Cantilena CC. Naturally Acquired SARS-CoV-2 Immunity Persists for Up to 11 Months Following Infection. J Infect Dis. 2021 Oct 28;224(8):1294-1304. doi: 10.1093/infdis/jiab295.

  PMID: 34089610 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Kamille A West-Mitchell, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: April 21, 2020
• Primary Completion: October 5, 2022
• Study Completion: October 5, 2022
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

US (1)