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NCT04582903 · ClinicalTrials.gov registry record

Send-In Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute COVID-19 and Convalescence

A clinical trial of COVID-19 Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Recruiting
Registry status
5,000
Enrollment target
1
Study location

NCT04582903 is a study of COVID-19 Infection that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 5,000 participants, above the 2,913-participant average among 21 other COVID-19 Infection trials with a reported enrollment target (72% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT04582903, a study of COVID-19 Infection, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

RECRUITING
Registry status
5,000 participants
Enrollment target
1
Study location

Study Summary

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19). The global outbreak of COVID-19 is a major public health problem. COVID-19 causes a wide range of symptoms. These symptoms range from mild breathing problems to life-threatening problems or death. Some people have no symptoms. This study aims to learn how acute and late immune responses to COVID-19 lead to different outcomes. The immune system is the body s defense against germs, including viruses, that invade the body. Objective: To characterize the immune responses during and after SARS-CoV-2 infection and determine if there is any relationship to clinical course and outcome. Eligibility: People ages 0 99 who have confirmed or suspected SARS-CoV-2 infection, people who are not infected despite heavy exposure, and relatives of enrolled participants. Design: This is a sample collection protocol to receive send-in biological specimens for exploratory studies, including gene testing. Participants will not be seen at the NIH for study visits. Study staff will talk with participants health care providers to screen them for the study. Participants enrolled into the protocol will send samples and clinical information at least once and more often if the participant has COVID-19. All participants will provide blood samples and possibly stool. We may also ask for left over specimens from any medical procedures completed as part of medical care. The study staff will also request participants health care providers to complete a survey to collect demographic and medical data. Some of this information may need to be provided directly by the participant. Pregnant individuals are invited to participate and may be asked to give cord blood samples after delivery. Study findings that affect participants health may be shared with their health care provider. Depending on findings, participants may be contacted to take part in other NIH studies.

Conditions Studied

Study Locations (1)

Maryland

  • Niaid/Lcim - Rockville

Trial Details

FieldValue
Enrollment Target 5,000 participants
Start Date 2020-10-13
Est. Completion 2031-01-31

What the Registry Record Tells You About NCT04582903

The ClinicalTrials.gov registry entry for NCT04582903 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 5,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,913-participant average among 21 other COVID-19 Infection trials with a reported enrollment target (72% higher). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with COVID-19 Infection appearing as the primary indexed condition, and to 0 interventions.

NCT04582903 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT04582903 about?

NCT04582903 is a clinical study titled "Send-In Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute COVID-19 and Convalescence". Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19). The global outbreak of COVID-19 is a major public health problem. COVID-19 causes a wide range of symptoms. These symptoms range from mild breathing problems to life-threatening prob...

What is the current status of trial NCT04582903?

This trial is currently recruiting. The enrollment target is 5,000 participants. The study started on 2020-10-13. Estimated completion is 2031-01-31.

What conditions does trial NCT04582903 study?

This clinical trial studies the following conditions: COVID-19 Infection.

Who is sponsoring clinical trial NCT04582903?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04582903 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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