Status:
COMPLETED
A Study of Immune Responses to the Virus That Causes COVID-19
Lead Sponsor:
COVID-19 Prevention Network
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
SARS-CoV-2
COVID-19
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed 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 enrollme...
Eligibility Criteria
Inclusion
- 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 or antigen test within six days prior to enrollment (target time) up to 10 days prior to enrollment (upper allowable window).
- Symptomatic (non-hospitalized) participants:
- Onset of mild symptoms consistent with COVID-19 within 6 days prior to enrollment (target time) up to 14 days prior to enrollment (upper allowable window). 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 or antigen test within six days prior to enrollment (target time) up to 10 days prior to enrollment (upper allowable window).
- 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 SARS-CoV-2 PCR or antigen testing for hospitalized participants)
Exclusion
- 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.
Key Trial Info
Start Date :
July 20 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 2 2022
Estimated Enrollment :
953 Patients enrolled
Trial Details
Trial ID
NCT04431414
Start Date
July 20 2020
End Date
June 2 2022
Last Update
July 26 2022
Active Locations (52)
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1
Alabama CRS
Birmingham, Alabama, United States, 35294
2
Bridge HIV CRS
San Francisco, California, United States, 94143
3
University of Miami Infectious Disease Research Unit at Jackson Memorial Hospital CRS
Miami, Florida, United States, 33136
4
The Ponce de Leon Center CRS
Atlanta, Georgia, United States, 30308