NCT04344977: NIAID

Collection of Anti-SARS-CoV-2 Immune Plasma

Completed Last updated 5 March 2021

What this trial tests

trial in Coronavirus Disease 2019 (COVID-19) in 151 participants. Completed in 3 March 2021.

Timeline

1 June 2020

Primary endpoint
20 November 2020

3 March 2021

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	151
Start date	1 June 2020
Primary completion	20 November 2020
Estimated completion	3 March 2021
Sites	3 locations across United States

Conditions studied

• Coronavirus Disease 2019 (COVID-19) — all drugs for Coronavirus Disease 2019 (COVID-19) →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 70, any sex, with Coronavirus Disease 2019 (COVID-19). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review.
   Piechotta V, Chai KL, Valk SJ, Doree C, et al · · 2020 · cited 148× · PMID 32648959 · DOI 10.1002/14651858.cd013600.pub2
2. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a rapid review.
   Valk SJ, Piechotta V, Chai KL, Doree C, et al · · 2020 · cited 126× · PMID 32406927 · DOI 10.1002/14651858.cd013600
3. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review.
   Piechotta V, Iannizzi C, Chai KL, Valk SJ, et al · · 2021 · cited 106× · PMID 34013969 · DOI 10.1002/14651858.cd013600.pub4
4. Convalescent Plasma Therapy for COVID-19: State of the Art.
   Focosi D, Anderson AO, Tang JW, Tuccori M. · · 2020 · cited 88× · PMID 32792417 · DOI 10.1128/cmr.00072-20
5. Clinical, laboratory, and temporal predictors of neutralizing antibodies against SARS-CoV-2 among COVID-19 convalescent plasma donor candidates.
   Boonyaratanakornkit J, Morishima C, Selke S, Zamora D, et al · · 2021 · cited 74× · PMID 33320842 · DOI 10.1172/jci144930
6. Scalable, Micro-Neutralization Assay for Assessment of SARS-CoV-2 (COVID-19) Virus-Neutralizing Antibodies in Human Clinical Samples.
   Bennett RS, Postnikova EN, Liang J, Gross R, et al · · 2021 · cited 31× · PMID 34065987 · DOI 10.3390/v13050893
7. Convalescent plasma for people with COVID-19: a living systematic review.
   Iannizzi C, Chai KL, Piechotta V, Valk SJ, et al · · 2023 · cited 24× · PMID 36734509 · DOI 10.1002/14651858.cd013600.pub5
8. Convalescent plasma for people with COVID-19: a living systematic review.
   Iannizzi C, Chai KL, Piechotta V, Valk SJ, et al · · 2023 · cited 21× · PMID 37162745 · DOI 10.1002/14651858.cd013600.pub6