A Study of Immune Responses to the Virus That Causes COVID-19 (CoVPN 5001)

A Prospective Study of Acute Immune Responses to SARSCoV-2 Infection

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; SARS-CoV-2
• Intervention / Treatment: Other: Sample collection

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.

• Study Type: Observational
• Enrollment (Actual): 953

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Fundacion Huesped CRS
  • Buenos Aires, Argentina
    • Hospital General de Agudos JM Ramos Mejía CRS
• Botswana
  • Gaborone, Botswana
    • Gaborone CRS
• Brazil
  • Belo Horizonte, Brazil
    • SOM Federal University Minas Gerais Brazil NICHD CRS
  • Rio de Janeiro, Brazil
    • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
• Malawi
  • Lilongwe, Malawi
    • Malawi CRS
• Mexico
  • Mérida, Mexico
    • Merida CRS
• Peru
  • Bellavista, Peru
    • CITBM - UNIDEC, Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS
  • Iquitos, Peru
    • Asociacion Civil Selva Amazonica (ASCA) CRS
  • Lima, Peru
    • Barranco CRS
  • Lima, Peru
    • San Miguel CRS
• South Africa
  • Cape Town, South Africa
    • Groote Schuur HIV CRS
  • Cape Town, South Africa
    • Khayelitsha CRS / (CIDRI UCT)
  • Cape Town, South Africa
    • Masiphumelele Clinical Research Site (MASI) CRS
  • Chatsworth, South Africa
    • Chatsworth CRS
  • Durban, South Africa
    • Botha's Hill CRS
  • Durban, South Africa
    • CAPRISA eThekwini CRS
  • Durban, South Africa
    • Vulindlela CRS
  • Elandsdoorn, South Africa
    • Ndlovu Research Centre CoVPN CRS
  • Isipingo, South Africa
    • Isipingo CRS
  • Johannesburg, South Africa
    • Kliptown Soweto CRS
  • Johannesburg, South Africa
    • Soweto HVTN CRS
  • Klerksdorp, South Africa
    • Aurum Institute Klerksdorp CRS
  • Ladysmith, South Africa
    • Qhakaza Mbokodo Research Clinic CRS
  • Medunsa, South Africa
    • MeCRU CRS
  • Mthatha, South Africa
    • Nelson Mandela Academic Research Unit CRS
  • Rustenburg, South Africa
    • Rustenburg CRS
  • Soshanguve, South Africa
    • Setshaba Research Centre CRS
  • Tembisa, South Africa
    • Tembisa Clinic 4 CoVPN CRS
  • Tongaat, South Africa
    • Tongaat CRS
• Tanzania
  • Mbeya, Tanzania
    • National Institute for Medical Research (NIMR) - Mbeya Medical Research Center (MMRC) Network CRS
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Alabama CRS
  • California
    • San Francisco, California, United States, 94143
      • Bridge HIV CRS
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Infectious Disease Research Unit at Jackson Memorial Hospital CRS
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • The Ponce de Leon Center CRS
    • Decatur, Georgia, United States, 30030
      • The Hope Clinic of the Emory Vaccine Center CRS
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • New Orleans Adolescent Trials Unit CRS
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University CRS
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • New Jersey Medical School Clinical Research Center CRS
  • New York
    • New York, New York, United States, 10065
      • New York Blood Center CRS
    • New York, New York, United States, 10032
      • Columbia P&S CRS
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Chapel Hill CRS
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case CRS
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Prevention CRS
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Vaccine and Prevention CRS
• Zambia
  • Lusaka, Zambia
    • Matero Reference Clinic CRS
  • Lusaka, Zambia
    • Zambia Emory HIV Research Project - Lusaka CoVPN CRS
  • Ndola, Zambia
    • Zambia Emory HIV Research Project - Ndola CoVPN CRS
• Zimbabwe
  • Chitungwiza, Zimbabwe
    • St Mary's CRS
  • Harare, Zimbabwe
    • Milton Park CRS
  • Harare, Zimbabwe
    • Seke South CRS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Persons that are positive for SARS-CoV-2 and are asymptomatic	Other: 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)	Other: 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	Other: Sample collection; blood, nasal swab, nasal wash, and saliva; optional stool swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitation of viral RNA in nasal swabs	Measured by extraction of nucleic acid for analysis of microorganism RNA or DNA by qPCR and/or amplicon- or metagenomics-sequencing methods and subsequent gene and taxa-level bioinformatics analyses	Measured through day 28

Collaborators and Investigators

• Sponsor: COVID-19 Prevention Network
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Chair: Will Hahn, Fred Hutch; Study Chair: Amy Ward, Cape Town - Khayelitsha

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2020
• Primary Completion (ACTUAL): June 2, 2022
• Study Completion (ACTUAL): June 2, 2022

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (ACTUAL): June 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CoVPN 5001; 5UM1AI068614-14 (NIH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No