Collection of Anti-SARS-CoV-2 Immune Plasma (NIAID)

A Pilot Study for Collection of Anti-SARS-CoV-2 Immune Plasma

Background:

The human disease caused by SARS-CoV-2 is called COVID-19. In most cases, COVID-19 is a mild to moderate respiratory illness. But it can also be more severe and even lead to death. There is no vaccine to prevent SARS-CoV-2 infection. There is also no therapy to treat COVID-19. Researchers want to collect plasma from adults who have recovered from COVID-19, which may help them develop treatments.

Objective:

To collect anti-SARS-CoV-2 immune plasma from adult volunteers who have recovered from COVID-19.

Eligibility:

Males and females ages 18 to 70 who have a history of COVID-19 like illness or positive test for SARS-CoV-2, and have a minimum level of SARS-CoV-2 antibodies as specified by the study.

Design:

This study consists of 2 parts: 1) screening for SARS-CoV-2 antibody titer and eligibility to donate plasma and 2) plasma collection by apheresis. Study sites may participate in 1 part alone (either screening or plasma collection only) or both parts (screening and plasma collection).

For screening part: Participants will be screened for their eligibility to join this research study with a medical history and physical exam. Their vital signs (blood pressure, heart rate, temperature, respiration rate) will be taken. Their weight and height will be recorded. They will give a blood sample for clinical laboratory tests of their general health and a research test for SARS-CoV-2 antibodies. They will discuss their history of COVID-19-like illness and any testing for SARS-CoV-2. They will be evaluated for their ability to donate plasma.

For plasma collection part: Subjects meeting criteria for plasma donation and found to have high neutralizing antibody titers and who plan to donate plasma under this part of the study will be scheduled for 1 (and up to 20) plasma collection sessions. These will occur no less than 7 days apart.

Prior to each donation, participants will have a brief physical exam and complete a donor history questionnaire. They will be asked about any current SARS-CoV-2 infection symptoms.

At each donation, plasma will be taken through a standard apheresis procedure. For this, blood will be withdrawn through a needle placed in the participant's arm vein. A machine will separate the plasma from the red cells. The red cells will be returned to the participant, either through the same needle or through a second needle in the other arm.

Participation may last up to 240 days.

Study Overview

• Status: Completed
• Conditions: Coronavirus Disease 2019 (COVID-19)

Detailed Description

Coronavirus disease 2019 (COVID-19) is a respiratory disease caused by a novel coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent infection with SARS-CoV-2 or therapeutic agent to treat COVID-19. The objective of this protocol is the identification of eligible donors and collection of anti-SARSCoV-2 immune plasma from convalescent survivors of COVID-19 illness.

Potential subjects will be screened for eligibility to participate in plasma donations and their blood measured for antibodies to SARS-CoV-2. Enrolled subjects will receive a baseline physical and laboratory examination. Subjects with high SARS-CoV-2 neutralizing antibody titers who meet standard blood bank criteria for plasma donation will then be scheduled for plasma collection sessions. Following testing of the collected plasma for potential pathogens, this plasma may be used and/or converted into an intravenous immunoglobulin (IVIG) preparation for further study.

• Study Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States, 90502
      • Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Infectious Diseases Research Unit
  • Washington
    • Seattle, Washington, United States, 98104
      • Bloodworks Northwest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Convalescent survivors of COVID-19 will be recruited at sites around the US.

Description

INCLUSION CRITERIA:

1. Provide written informed consent before initiation of any study procedures.
2. Age greater than or equal to 18 years old and less than or equal to 70 years old.

3. Subjects must not be symptomatic, must be afebrile for ≥14 days, beyond 28 days of the resolution of their acute COVID-19 illness, and must enroll within 18 months of onset of illness, and must meet at least 1 of the following:

   • History suggestive of resolved COVID-19-like illness (e.g., prior fever, dry cough, and shortness of breath). OR
   • History of positive test for SARS-CoV-2 (either serologic or RT-PCR) OR
   • Documented anti-SARSCoV-2 neutralizing antibody titer of at least 1:80
4. Current anti-SARS-CoV-2 neutralizing antibody titer of at least 1:80
5. Females must have a negative anti-HLA screening test
6. Weight greater than or equal to110 pounds (50 kg)
7. Meets FDA-approved criteria per local blood collector for plasmapheresis for plasma donation
8. Adequate peripheral venous access for plasma donation (as judged by the examiner)
9. Willingness to have samples stored

EXCLUSION CRITERIA:

1. Any sign of active illness of any kind including COVID-19 illness (as judged by the investigator), including but not limited to:

   • Subjective or documented fever (greater than or equal to 38°C)
   • Dry cough
   • Shortness of breath

2. Participation in medical research that includes:

   • Protocols that are currently ongoing or will start during the duration of this study that require more than 100 mL of blood to be given in any 8-week period of time
   • Administration of any unlicensed drug within the last 1 month or during the duration of this study, per investigation discretion
   • Administration of any unlicensed vaccine within the last 12 months or during the duration of this study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Convalescent survivors of COVID-19; Convalescent survivors of COVID-19: history of COVID-19 like illness or positive test for SARS-CoV-2 and has the protocol-specified minimum anti-SARS-CoV-2 neutralizing antibody titer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of eligible donors and collection of anti-SARS-CoV-2 immune plasma	Donors screened and identified and anti-SARS-CoV-2 immune plasma collected	Screening, Days 120 or 240

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): November 20, 2020
• Study Completion (Actual): March 3, 2021

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Coronavirus; COVID-19; IVIG; Severe acute respiratory syndrome coronavirus 2; Convalescent plasma
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: 200081; 20-I-0081 (Other Identifier: NIHCC)

Drug and device information, study documents

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