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

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 Blood will be withdrawn.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 Blood will be withdrawn.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.

Study Overview

• Status: Completed
• Conditions: COVID-19

Detailed Description

Emerging infectious diseases such as the Coronavirus disease 2019 (COVID-19) pandemic cause substantial morbidity and mortality. During the early emergent phases of such diseases, there is often no vaccine to prevent infection, nor specific therapeutic agent to treat the disease. The objective of this protocol is the collection of immune plasma from persons post-recovery from COVID-19 or vaccination against SARS-CoV-2. This plasma may potentially be used in the treatment or prophylaxis of active COVID-19 under other protocols.

Candidates will be screened for eligibility to participate in plasma donations and their blood levels of antibodies to SARS-CoV-2. Enrolled subjects will receive a baseline physical and laboratory examination. Subjects with sufficient anti-SARS-CoV-2 antibody titers who meet standard blood bank criteria for plasma donation will then be scheduled for plasma collections. Plasmapheresis is the preferred method of collection, with up to 800 mL of plasma collected per donation depending on the weight of the donor. Collected immune plasma will be tested for blood-borne pathogens, and stored according to standard blood bank procedures. The scope of this protocol is limited to collection of plasma from subjects with sufficiently high anti-SARS-CoV-2 antibody titer. Any administration of convalescent immune plasma to subjects will be performed under a separate protocol.

• Study Type: Observational
• Enrollment (Actual): 258

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

• INCLUSION CRITERIA:
• 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

EXCLUSION CRITERIA:

• 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
• Unwillingness to have samples stored for clinical and/or genetic research testing

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Plasma Donors; Persons who have recovered from COVID-19 or have been immunized against SARS-CoV-2 who meet criteria to donate plasma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of convalescent plasma	Successful collection of convalescent or immunized donor plasma.	240 days

Collaborators and Investigators

• Sponsor: National Institutes of Health Clinical Center (CC)
• Investigators: Principal Investigator: Kamille A West-Mitchell, M.D., National Institutes of Health Clinical Center (CC)

Publications and helpful links

General Publications

• 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.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2020
• Primary Completion (Actual): October 5, 2022
• Study Completion (Actual): October 5, 2022

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Natural History; Antibodies; Titer
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 200092; 20-CC-0092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: .aa

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No