Clinical trial NCT04431414: A Study of Immune Responses to the Virus That Causes COVID-19
Official title: A Prospective Study of Acute Immune Responses to SARSCoV-2 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2
COVID-19
Lead sponsor: COVID-19 Prevention Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2020-06-16
Enrollment: 953
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants who have tested positive for SARSCoV-2 virus by RT-PCR or antigen testing.

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 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.

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 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.

Eligibility criteria: 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 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:

* 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.

Primary outcomes:
measure: Response rate of SARS-CoV-2-specific B cells in peripheral blood samples
timeFrame: Measured through day 14
measure: Magnitude of SARS-CoV-2-specific B cells in peripheral blood samples
timeFrame: Measured through day 14
measure: Phenotypic characterization of SARS-CoV-2-specific B cells in peripheral blood samples
timeFrame: Measured through day 14
measure: Response rate of SARS-CoV-2-specific antibody binding in serum samples
timeFrame: Measured through day 28
measure: Response rate of SARS-CoV-2-specific neutralizing antibodies in serum samples
timeFrame: Measured through day 28
measure: Magnitude of SARS-CoV-2-specific antibody binding antibodies in serum samples
timeFrame: Measured through day 28
measure: Magnitude of SARS-CoV-2-specific neutralizing antibodies in serum samples
timeFrame: Measured through day 28
measure: Response rate of SARS-CoV-2-specific binding antibodies in nasal wash samples
timeFrame: Measured through day 28
measure: Magnitude of SARS-CoV-2-specific binding antibodies in nasal wash samples
timeFrame: Measured through day 28
measure: Frequency of leukocyte populations in peripheral blood
timeFrame: Measured through day 14
measure: Transcriptional profiles of peripheral blood leukocytes
timeFrame: Measured through day 14
measure: Concentration of serum cytokines and other soluble factors
timeFrame: Measured through day 28
measure: Response rate of SARS-CoV-2-specific CD4+ and CD8+ T cells
timeFrame: Measured through day 28
measure: Magnitude of SARS-CoV-2-specific CD4+ and CD8+ T cells
timeFrame: Measured through day 28
measure: Functional profiling, including intracellular cytokine staining, of SARS-CoV-2-specific CD4+ and CD8+ T cells
timeFrame: Measured through day 28
Secondary outcomes:
measure: Quantitation of viral RNA in nasal swabs
timeFrame: Measured through day 28
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama CRS
state: Alabama
city: San Francisco
country: United States
facility: Bridge HIV CRS
state: California
city: Miami
country: United States
facility: University of Miami Infectious Disease Research Unit at Jackson Memorial Hospital CRS
state: Florida
city: Atlanta
country: United States
facility: The Ponce de Leon Center CRS
state: Georgia
city: Decatur
country: United States
facility: The Hope Clinic of the Emory Vaccine Center CRS
state: Georgia
city: New Orleans
country: United States
facility: New Orleans Adolescent Trials Unit CRS
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University CRS
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
state: Massachusetts
city: Newark
country: United States
facility: New Jersey Medical School Clinical Research Center CRS
state: New Jersey
city: New York
country: United States
facility: Columbia P&S CRS
state: New York
city: New York
country: United States
facility: New York Blood Center CRS
state: New York
city: Chapel Hill
country: United States
facility: Chapel Hill CRS
state: North Carolina
city: Cleveland
country: United States
facility: Case CRS
state: Ohio
city: Philadelphia
country: United States
facility: Penn Prevention CRS
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Vaccine and Prevention CRS
state: Washington
city: Buenos Aires
country: Argentina
facility: Fundacion Huesped CRS
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos JM Ramos Mejía CRS
city: Gaborone
country: Botswana
facility: Gaborone CRS
city: Belo Horizonte
country: Brazil
facility: SOM Federal University Minas Gerais Brazil NICHD CRS
city: Rio de Janeiro
country: Brazil
facility: Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
city: Lilongwe
country: Malawi
facility: Malawi CRS
city: Mérida
country: Mexico
facility: Merida CRS
city: Bellavista
country: Peru
facility: CITBM - UNIDEC, Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS
city: Iquitos
country: Peru
facility: Asociacion Civil Selva Amazonica (ASCA) CRS
city: Lima
country: Peru
facility: Barranco CRS
city: Lima
country: Peru
facility: San Miguel CRS
city: Cape Town
country: South Africa
facility: Groote Schuur HIV CRS
city: Cape Town
country: South Africa
facility: Khayelitsha CRS / (CIDRI UCT)
city: Cape Town
country: South Africa
facility: Masiphumelele Clinical Research Site (MASI) CRS
city: Chatsworth
country: South Africa
facility: Chatsworth CRS
city: Durban
country: South Africa
facility: Botha's Hill CRS
city: Durban
country: South Africa
facility: CAPRISA eThekwini CRS
city: Durban
country: South Africa
facility: Vulindlela CRS
city: Elandsdoorn
country: South Africa
facility: Ndlovu Research Centre CoVPN CRS
city: Isipingo
country: South Africa
facility: Isipingo CRS
city: Johannesburg
country: South Africa
facility: Kliptown Soweto CRS
city: Johannesburg
country: South Africa
facility: Soweto HVTN CRS
city: Klerksdorp
country: South Africa
facility: Aurum Institute Klerksdorp CRS
city: Ladysmith
country: South Africa
facility: Qhakaza Mbokodo Research Clinic CRS
city: Medunsa
country: South Africa
facility: MeCRU CRS
city: Mthatha
country: South Africa
facility: Nelson Mandela Academic Research Unit CRS
city: Rustenburg
country: South Africa
facility: Rustenburg CRS
city: Soshanguve
country: South Africa
facility: Setshaba Research Centre CRS
city: Tembisa
country: South Africa
facility: Tembisa Clinic 4 CoVPN CRS
city: Tongaat
country: South Africa
facility: Tongaat CRS
city: Mbeya
country: Tanzania
facility: National Institute for Medical Research (NIMR) - Mbeya Medical Research Center (MMRC) Network CRS
city: Lusaka
country: Zambia
facility: Matero Reference Clinic CRS
city: Lusaka
country: Zambia
facility: Zambia Emory HIV Research Project - Lusaka CoVPN CRS
city: Ndola
country: Zambia
facility: Zambia Emory HIV Research Project - Ndola CoVPN CRS
city: Chitungwiza
country: Zimbabwe
facility: St Mary's CRS
city: Harare
country: Zimbabwe
facility: Milton Park CRS
city: Harare
country: Zimbabwe
facility: Seke South CRS
Study officials:
affiliation: Fred Hutch
name: Will Hahn
role: STUDY_CHAIR
affiliation: Cape Town - Khayelitsha
name: Amy Ward
role: STUDY_CHAIR
References: