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

Completed

Conditions studied: SARS-CoV-2, COVID-19

In brief

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.

Key facts

Study ID

NCT04431414

Run by

COVID-19 Prevention Network

People needed

953

Starts

2020-07-20

Expected to finish

2022-06-02

Last updated by the study team

2022-07-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• 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
• Alabama CRS — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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