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

NCT04431414 | Completed

• 2 other identifiers: CoVPN 50015UM1AI068614-14
• Study Type: observational
• Target: 953
• Locations: 10 countries
• Sites: 33

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.

Conditions

SARS-CoV-2; COVID-19

Outcome Measures

Primary Outcomes (15)

• Response rate of SARS-CoV-2-specific B cells in peripheral blood samples

  Characterized using fluorescently labeled recombinant proteins in combination with a flow cytometry phenotyping panel

  Measured through day 14

• Magnitude of SARS-CoV-2-specific B cells in peripheral blood samples

  Characterized using fluorescently labeled recombinant proteins in combination with a flow cytometry phenotyping panel

  Measured through day 14

• Phenotypic characterization of SARS-CoV-2-specific B cells in peripheral blood samples

  Characterized using fluorescently labeled recombinant proteins in combination with a flow cytometry phenotyping panel

  Measured through day 14

• Response rate of SARS-CoV-2-specific antibody binding in serum samples

  Measured by binding antibody multiplex assay (BAMA)

  Measured through day 28

• Response rate of SARS-CoV-2-specific neutralizing antibodies in serum samples

  Measured by neutralizing antibody assay (nAb)

  Measured through day 28

• Magnitude of SARS-CoV-2-specific antibody binding antibodies in serum samples

  Measured by binding antibody multiplex assay (BAMA)

  Measured through day 28

• Magnitude of SARS-CoV-2-specific neutralizing antibodies in serum samples

  Measured by neutralizing antibody assay (nAb)

  Measured through day 28

• Response rate of SARS-CoV-2-specific binding antibodies in nasal wash samples

  Measured by binding antibody multiplex assay (BAMA)

  Measured through day 28

• Magnitude of SARS-CoV-2-specific binding antibodies in nasal wash samples

  Measured by binding antibody multiplex assay (BAMA)

  Measured through day 28

• Frequency of leukocyte populations in peripheral blood

  Measured by flow cytometry

  Measured through day 14

• Transcriptional profiles of peripheral blood leukocytes

  Measured by gene expression analysis by RNA sequencing, real-time PCR, single-cell proteogenomic profiling

  Measured through day 14

• Concentration of serum cytokines and other soluble factors

  Measured by multiplexed protein detection assays and/or enzyme-linked immunosorbent assays (ELISA)

  Measured through day 28

• Response rate of SARS-CoV-2-specific CD4+ and CD8+ T cells

  Measured by flow cytometry

  Measured through day 28

• Magnitude of SARS-CoV-2-specific CD4+ and CD8+ T cells

  Measured by flow cytometry

  Measured through day 28

• Functional profiling, including intracellular cytokine staining, of SARS-CoV-2-specific CD4+ and CD8+ T cells

  Measured by flow cytometry

  Measured through day 28

Secondary Outcomes (1)

• Quantitation of viral RNA in nasal swabs

  Measured through day 28

Study Arms (3)

Group 1

Persons that are positive for SARS-CoV-2 and are asymptomatic

Other: Sample collection

Group 2

Persons that are positive for SARS-CoV-2 with recent onset of mild symptoms (not hospitalized)

Other: Sample collection

Group 3

Persons that are positive for SARS-CoV-2 and are symptomatic hospitalized patients

Other: Sample collection

Interventions

Sample collection OTHER

* blood, nasal swab, nasal wash, and saliva * optional stool swab

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants who have tested positive for SARSCoV-2 virus by RT-PCR or antigen testing.

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

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.

Sponsors & Collaborators

• COVID-19 Prevention Network: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (52)

Alabama CRS

Birmingham, Alabama, 35294, United States

Location

Bridge HIV CRS

San Francisco, California, 94143, United States

Location

University of Miami Infectious Disease Research Unit at Jackson Memorial Hospital CRS

Miami, Florida, 33136, United States

Location

The Ponce de Leon Center CRS

Atlanta, Georgia, 30308, United States

Location

The Hope Clinic of the Emory Vaccine Center CRS

Decatur, Georgia, 30030, United States

Location

New Orleans Adolescent Trials Unit CRS

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins University CRS

Baltimore, Maryland, 21205, United States

Location

Brigham and Women's Hospital Vaccine CRS (BWH VCRS)

Boston, Massachusetts, 02115, United States

Location

New Jersey Medical School Clinical Research Center CRS

Newark, New Jersey, 07103, United States

Location

Columbia P&S CRS

New York, New York, 10032, United States

Location

New York Blood Center CRS

New York, New York, 10065, United States

Location

Chapel Hill CRS

Chapel Hill, North Carolina, 27599, United States

Location

Case CRS

Cleveland, Ohio, 44106, United States

Location

Penn Prevention CRS

Philadelphia, Pennsylvania, 19104, United States

Location

Seattle Vaccine and Prevention CRS

Seattle, Washington, 98109, United States

Location

Fundacion Huesped CRS

Buenos Aires, Argentina

Location

Hospital General de Agudos JM Ramos Mejía CRS

Buenos Aires, Argentina

Location

Gaborone CRS

Gaborone, Botswana

Location

SOM Federal University Minas Gerais Brazil NICHD CRS

Belo Horizonte, Brazil

Location

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

Rio de Janeiro, Brazil

Location

Malawi CRS

Lilongwe, Malawi

Location

Merida CRS

Mérida, Mexico

Location

CITBM - UNIDEC, Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS

Bellavista, Peru

Location

Asociacion Civil Selva Amazonica (ASCA) CRS

Iquitos, Peru

Location

Barranco CRS

Lima, Peru

Location

San Miguel CRS

Lima, Peru

Location

Groote Schuur HIV CRS

Cape Town, South Africa

Location

Khayelitsha CRS / (CIDRI UCT)

Cape Town, South Africa

Location

Masiphumelele Clinical Research Site (MASI) CRS

Cape Town, South Africa

Location

Chatsworth CRS

Chatsworth, South Africa

Location

Botha's Hill CRS

Durban, South Africa

Location

CAPRISA eThekwini CRS

Durban, South Africa

Location

Vulindlela CRS

Durban, South Africa

Location

Ndlovu Research Centre CoVPN CRS

Elandsdoorn, South Africa

Location

Isipingo CRS

Isipingo, South Africa

Location

Kliptown Soweto CRS

Johannesburg, South Africa

Location

Soweto HVTN CRS

Johannesburg, South Africa

Location

Aurum Institute Klerksdorp CRS

Klerksdorp, South Africa

Location

Qhakaza Mbokodo Research Clinic CRS

Ladysmith, South Africa

Location

MeCRU CRS

Medunsa, South Africa

Location

Nelson Mandela Academic Research Unit CRS

Mthatha, South Africa

Location

Rustenburg CRS

Rustenburg, South Africa

Location

Setshaba Research Centre CRS

Soshanguve, South Africa

Location

Tembisa Clinic 4 CoVPN CRS

Tembisa, South Africa

Location

Tongaat CRS

Tongaat, South Africa

Location

National Institute for Medical Research (NIMR) - Mbeya Medical Research Center (MMRC) Network CRS

Mbeya, Tanzania

Location

Matero Reference Clinic CRS

Lusaka, Zambia

Location

Zambia Emory HIV Research Project - Lusaka CoVPN CRS

Lusaka, Zambia

Location

Zambia Emory HIV Research Project - Ndola CoVPN CRS

Ndola, Zambia

Location

St Mary's CRS

Chitungwiza, Zimbabwe

Location

Milton Park CRS

Harare, Zimbabwe

Location

Seke South CRS

Harare, Zimbabwe

Location

MeSH Terms

Conditions

COVID-19

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Will Hahn

  Fred Hutch

  STUDY CHAIR

• Amy Ward

  Cape Town - Khayelitsha

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 16, 2020
• Study Start: July 20, 2020
• Primary Completion: June 2, 2022
• Study Completion: June 2, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Locations

MA (1); ME (1); ZA (3); TA (1); US (15); PE (4); ZI (3); BO (1); BR (2); AR (2)