A Study of Immune Responses to the Virus That Causes COVID-19
NCT ID: NCT04431414
Last Updated: 2022-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
953 participants
OBSERVATIONAL
2020-07-20
2022-06-02
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Persons that are positive for SARS-CoV-2 and are asymptomatic
Sample collection
* blood, nasal swab, nasal wash, and saliva
* optional stool swab
Group 2
Persons that are positive for SARS-CoV-2 with recent onset of mild symptoms (not hospitalized)
Sample collection
* blood, nasal swab, nasal wash, and saliva
* optional stool swab
Group 3
Persons that are positive for SARS-CoV-2 and are symptomatic hospitalized patients
Sample collection
* blood, nasal swab, nasal wash, and saliva
* optional stool swab
Interventions
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Sample collection
* blood, nasal swab, nasal wash, and saliva
* optional stool swab
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
COVID-19 Prevention Network
NETWORK
Responsible Party
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Principal Investigators
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Will Hahn
Role: STUDY_CHAIR
Fred Hutch
Amy Ward
Role: STUDY_CHAIR
Cape Town - Khayelitsha
Locations
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Alabama CRS
Birmingham, Alabama, United States
Bridge HIV CRS
San Francisco, California, United States
University of Miami Infectious Disease Research Unit at Jackson Memorial Hospital CRS
Miami, Florida, United States
The Ponce de Leon Center CRS
Atlanta, Georgia, United States
The Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, United States
New Orleans Adolescent Trials Unit CRS
New Orleans, Louisiana, United States
Johns Hopkins University CRS
Baltimore, Maryland, United States
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, United States
New Jersey Medical School Clinical Research Center CRS
Newark, New Jersey, United States
Columbia P&S CRS
New York, New York, United States
New York Blood Center CRS
New York, New York, United States
Chapel Hill CRS
Chapel Hill, North Carolina, United States
Case CRS
Cleveland, Ohio, United States
Penn Prevention CRS
Philadelphia, Pennsylvania, United States
Seattle Vaccine and Prevention CRS
Seattle, Washington, United States
Fundacion Huesped CRS
Buenos Aires, , Argentina
Hospital General de Agudos JM Ramos Mejía CRS
Buenos Aires, , Argentina
Gaborone CRS
Gaborone, , Botswana
SOM Federal University Minas Gerais Brazil NICHD CRS
Belo Horizonte, , Brazil
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, , Brazil
Malawi CRS
Lilongwe, , Malawi
Merida CRS
Mérida, , Mexico
CITBM - UNIDEC, Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS
Bellavista, , Peru
Asociacion Civil Selva Amazonica (ASCA) CRS
Iquitos, , Peru
Barranco CRS
Lima, , Peru
San Miguel CRS
Lima, , Peru
Groote Schuur HIV CRS
Cape Town, , South Africa
Khayelitsha CRS / (CIDRI UCT)
Cape Town, , South Africa
Masiphumelele Clinical Research Site (MASI) CRS
Cape Town, , South Africa
Chatsworth CRS
Chatsworth, , South Africa
Botha's Hill CRS
Durban, , South Africa
CAPRISA eThekwini CRS
Durban, , South Africa
Vulindlela CRS
Durban, , South Africa
Ndlovu Research Centre CoVPN CRS
Elandsdoorn, , South Africa
Isipingo CRS
Isipingo, , South Africa
Kliptown Soweto CRS
Johannesburg, , South Africa
Soweto HVTN CRS
Johannesburg, , South Africa
Aurum Institute Klerksdorp CRS
Klerksdorp, , South Africa
Qhakaza Mbokodo Research Clinic CRS
Ladysmith, , South Africa
MeCRU CRS
Medunsa, , South Africa
Nelson Mandela Academic Research Unit CRS
Mthatha, , South Africa
Rustenburg CRS
Rustenburg, , South Africa
Setshaba Research Centre CRS
Soshanguve, , South Africa
Tembisa Clinic 4 CoVPN CRS
Tembisa, , South Africa
Tongaat CRS
Tongaat, , South Africa
National Institute for Medical Research (NIMR) - Mbeya Medical Research Center (MMRC) Network CRS
Mbeya, , Tanzania
Matero Reference Clinic CRS
Lusaka, , Zambia
Zambia Emory HIV Research Project - Lusaka CoVPN CRS
Lusaka, , Zambia
Zambia Emory HIV Research Project - Ndola CoVPN CRS
Ndola, , Zambia
St Mary's CRS
Chitungwiza, , Zimbabwe
Milton Park CRS
Harare, , Zimbabwe
Seke South CRS
Harare, , Zimbabwe
Countries
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Other Identifiers
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CoVPN 5001
Identifier Type: -
Identifier Source: org_study_id
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