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

• ClinicalTrials.gov Identifier: NCT04360278
• Recruitment Status: Recruiting
• First Posted: April 24, 2020
• Last Update Posted: September 14, 2020
• Sponsor: National Institutes of Health Clinical Center (CC)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC)

Study Description

Brief Summary:

Background:

The Coronavirus disease 2019 (COVID-19) pandemic is a major public health issue. Right now, there is no vaccine to keep people from getting sick. There is also no treatment for people who do get sick. Researchers want to collect plasma from people who have recovered from COVID-19. The plasma will have antibodies against the virus that causes COVID-19. If a vaccine is made, people who develop immunity from the vaccine can also donate plasma.

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, or have been vaccinated against the virus that causes 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 Blood will be withdrawn.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 Blood will be withdrawn.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 240 days.

Condition or disease
COVID-19

Detailed Description:

Emerging infectious diseases such as the Coronavirus disease 2019 (COVID-19) pandemic cause substantial morbidity and mortality. Duringthe early emergent phases of such diseases, there is often no vaccine to prevent infection, nor specifictherapeutic 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 neutralizing 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 neutralizing antibody titer. Any administration of convalescent immune plasma to subjects will be performed under a separate protocol.

Study Design

• Study Type: Observational
• Estimated Enrollment: 1500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Plasma Collection From Convalescent and/or Immunized Donors for the Treatment of COVID-19
• Actual Study Start Date: April 21, 2020
• Estimated Primary Completion Date: April 14, 2030
• Estimated Study Completion Date: April 14, 2030

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Collection of convalescent plasma [ Time Frame: 240 days ]
   Successful collection of convalescent or immunized donor plasma.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

• 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 Code of Federal Regulations 21 CFR 630 and AABB Standards, 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)

    • Systolic blood pressure >100 and <180 mmHg
    • Diastolic blood pressure >50 and <100 mmHg
    • Heart rate between 50-100 beats/minute

• 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 14 days prior to donation, with negative results for COVID-19 either from one or more nasopharyngeal swab specimens or by a molecular diagnostic test from blood. A partial list of available tests can be accessed at https://www.fda.gov/medical-devices/emergency-situations-medicaldevices/ emergency-use-authorizations
  • If the donor is >= 28 days from date of last COVID-19-related symptom, then a negative COVID-19 test results are not needed.
  • 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 be at least 14 days post-vaccination with an FDA-approved vaccine

• Willingness to engage in repeat plasma collections for a 120-day period with possible extension to 240 days, provided neutralizing antibody 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

• 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

• Failure to meet blood donor eligibility criteria as defined in the Code of Federal Regulations

  • 21 CFR 630 and AABB Standards, including:
  • History of heart, lung or blood disease that compromises blood donor safety
  • History of cancer that meets DTM criteria for deferral
  • Medication deferrals per AABB donor education materials
  • Vaccinations as per FDA regulations and AABB standards

  • Risk or evidence of Relevant Transfusion Transmissible Infections (rTTI)

    • High-risk sexual history
    • Variant Creutzfeldt-Jakob disease (vCJD) risk
    • Intravenous drug abuse (IVDA)
    • Tattoos (from unlicensed facilities)
  • Blood donation within the required period of deferral (8 weeks post-whole blood donation, 16 weeks post-double red cell apheresis)
  • Received blood transfusion or transplantation within the time specified for each, per FDA/AABB guidelines

• 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

• Receipt of any investigational (not FDA-approved) vaccine for SARS-CoV-2 within the last 12 months or during the duration of this study
• Total plasma protein level < 6.0 g/dL
• Unwillingness to engage in repeat plasma collections for a 120-day period with possible extension to 240 days, provided neutralizing antibody titers remain sufficiently high
• Unwillingness to have samples stored for clinical and/or genetic research testing

Contacts and Locations

Contacts

Contact: Sarah Pogue, R.N.; (301) 435-2432; spogue1@mail.nih.gov

Locations

United States, Maryland

National Institutes of Health Clinical Center; Recruiting

Bethesda, Maryland, United States, 20892

Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov

Sponsors and Collaborators

National Institutes of Health Clinical Center (CC)

Investigators

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

More Information

Additional Information:

NIH Clinical Center Detailed Web Page 

• Responsible Party: National Institutes of Health Clinical Center (CC)
• ClinicalTrials.gov Identifier: NCT04360278
• Other Study ID Numbers: 200092; 20-CC-0092
• First Posted: April 24, 2020
• Last Update Posted: September 14, 2020
• Last Verified: September 10, 2020

Keywords provided by National Institutes of Health Clinical Center (CC):

Titer; Antibodies