A Study of Immune Responses to the Virus That Causes COVID-19

  • STATUS
    Recruiting
  • participants needed
    800
  • sponsor
    COVID-19 Prevention Network
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Updated on 16 February 2024
See if I qualify
fever
rhinorrhea
dyspnea
diarrhea
cough
headache
pharyngitis
covid-19
chills
myalgia
SARS
sore throat
coronavirus infection
antigen test
anosmia
throat
acute respiratory syndrome (sars)

Summary

The purpose of this study is to learn more about the acute response to infection with and recovery from the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some people know this virus by the name "coronavirus." It can cause the disease called COVID-19.

The information gained from the study can be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines, other prevention strategies, and treatments.

Description

This is a prospective study of acute immune responses to SARSCoV-2 infection.

The study will include 3 groups, as described in the table below. Groups are defined based on clinical status at enrollment, but for the purposes of data analysis, participants who experience disease progression can contribute data to other cohorts.

Participants will complete six visits over 28 days followed by a health contact at Month 2 (one month after the last scheduled visit). Additional follow up visit(s) may be added over time in response to evolving information regarding SARS-CoV-2 infection and COVID-19.

Study visits may include review of medical history; interviews/questionnaires; pregnancy tests (for participants assigned female sex at birth); blood draws; nasal swab, nasal wash, and saliva sample collection; and optional stool sample collection.

Details
Condition Covid 19, SARS-CoV-2
Age 18years - 100years
Treatment Sample collection
Clinical Study IdentifierNCT04431414
SponsorCOVID-19 Prevention Network
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age 18 years or older
Test result indicating presence of SARS-CoV-2 virus. Sites must have results from assays that are approved as FDA-emergency use authorized or as standard-of-care by other applicable regional governing bodies. For timing of testing, please see group specific criteria below
Ability and willingness to provide informed consent
Willingness to have clinical research staff come to place of residence or hospital if needed
Willingness to be followed for the planned duration of the study
Assessment of understanding: volunteer demonstrates understanding of this study
Agreement to allow access to medical records
Asymptomatic participants
No current symptoms
No symptoms consistent with COVID-19 within 2 weeks prior to positive test according to the clinical judgement of the investigating clinician. Symptoms include, but are not limited to, fever, headache, sore throat, cough, dyspnea, rhinorrhea, diarrhea, myalgias, chills, and anosmia. Please refer to <https://www.cdc.gov/coronavirus/2019-ncov/symptomstesting/symptoms.html> for the current list of symptoms consistent with COVID-19
Positive SARS-CoV-2 RNA test within six days prior to enrollment
Symptomatic (non-hospitalized) participants
Onset of mild symptoms consistent with COVID-19 within 6 days prior to enrollment. Symptoms of COVID-19 to be determined by the clinical judgement of the investigating clinician including-- but not limited to-- fever, headache, sore throat, cough, dyspnea, rhinorrhea, diarrhea myalgias, chills, and anosmia. Please refer to <https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html> for the current list of symptoms consistent with COVID-19
Positive SARS-CoV-2 RNA test within six days prior to enrollment
Symptomatic (hospitalized) participants
Participant hospitalized for COVID-19 within 3 days prior to enrollment (note: there is no timeframe for either symptom onset or timing of SARSCoV-2 PCR testing for hospitalized participants)

Exclusion Criteria

Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence or a volunteer's ability to give informed consent
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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fever
rhinorrhea
dyspnea
diarrhea
cough
headache
pharyngitis
covid-19
chills
myalgia
SARS
sore throat
coronavirus infection
antigen test
anosmia
throat
acute respiratory syndrome (sars)

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