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NCT04344977 · ClinicalTrials.gov registry record
Collection of Anti-SARS-CoV-2 Immune Plasma
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 151
- Enrollment target
NCT04344977: Completed study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04344977 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 151 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04344977 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 151 participants
- Enrollment target
Study Summary
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 a
Primary Outcome
Donors screened and identified and anti-SARS-CoV-2 immune plasma collected
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2021-03-03 |
What the finished NCT04344977 record still lists
NCT04344977 is an observational study that tracks outcomes without assigning an intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04344977 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04344977 about?
NCT04344977 is a clinical study titled "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. Researche...
What is the current status of trial NCT04344977?
This trial is currently completed. The enrollment target is 151 participants. The study started on 2020-06-01. Estimated completion is 2021-03-03.
Who is sponsoring clinical trial NCT04344977?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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