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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04431414
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
COVID-19 Prevention Network

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.


Condition or disease Intervention/treatment
SARS-CoV-2 COVID-19 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.

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Acute Immune Responses to SARSCoV-2 Infection
Actual Study Start Date : July 20, 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

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




Primary Outcome Measures :
  1. Response rate of SARS-CoV-2-specific B cells in peripheral blood samples [ Time Frame: Measured through day 14 ]
    Characterized using fluorescently labeled recombinant proteins in combination with a flow cytometry phenotyping panel

  2. Magnitude of SARS-CoV-2-specific B cells in peripheral blood samples [ Time Frame: Measured through day 14 ]
    Characterized using fluorescently labeled recombinant proteins in combination with a flow cytometry phenotyping panel

  3. Phenotypic characterization of SARS-CoV-2-specific B cells in peripheral blood samples [ Time Frame: Measured through day 14 ]
    Characterized using fluorescently labeled recombinant proteins in combination with a flow cytometry phenotyping panel

  4. Response rate of SARS-CoV-2-specific antibody binding in serum samples [ Time Frame: Measured through day 28 ]
    Measured by binding antibody multiplex assay (BAMA)

  5. Response rate of SARS-CoV-2-specific neutralizing antibodies in serum samples [ Time Frame: Measured through day 28 ]
    Measured by neutralizing antibody assay (nAb)

  6. Magnitude of SARS-CoV-2-specific antibody binding antibodies in serum samples [ Time Frame: Measured through day 28 ]
    Measured by binding antibody multiplex assay (BAMA)

  7. Magnitude of SARS-CoV-2-specific neutralizing antibodies in serum samples [ Time Frame: Measured through day 28 ]
    Measured by neutralizing antibody assay (nAb)

  8. Response rate of SARS-CoV-2-specific binding antibodies in nasal wash samples [ Time Frame: Measured through day 28 ]
    Measured by binding antibody multiplex assay (BAMA)

  9. Magnitude of SARS-CoV-2-specific binding antibodies in nasal wash samples [ Time Frame: Measured through day 28 ]
    Measured by binding antibody multiplex assay (BAMA)

  10. Frequency of leukocyte populations in peripheral blood [ Time Frame: Measured through day 14 ]
    Measured by flow cytometry

  11. Transcriptional profiles of peripheral blood leukocytes [ Time Frame: Measured through day 14 ]
    Measured by gene expression analysis by RNA sequencing, real-time PCR, single-cell proteogenomic profiling

  12. Concentration of serum cytokines and other soluble factors [ Time Frame: Measured through day 28 ]
    Measured by multiplexed protein detection assays and/or enzyme-linked immunosorbent assays (ELISA)

  13. Response rate of SARS-CoV-2-specific CD4+ and CD8+ T cells [ Time Frame: Measured through day 28 ]
    Measured by flow cytometry

  14. Magnitude of SARS-CoV-2-specific CD4+ and CD8+ T cells [ Time Frame: Measured through day 28 ]
    Measured by flow cytometry

  15. Functional profiling, including intracellular cytokine staining, of SARS-CoV-2-specific CD4+ and CD8+ T cells [ Time Frame: Measured through day 28 ]
    Measured by flow cytometry


Secondary Outcome Measures :
  1. Quantitation of viral RNA in nasal swabs [ Time Frame: Measured through day 28 ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants who have tested positive for SARSCoV-2 virus by RT-PCR or antigen testing.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04431414


Locations
Show Show 58 study locations
Sponsors and Collaborators
COVID-19 Prevention Network
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Study Chair: Will Hahn Fred Hutch
Study Chair: Amy Ward Cape Town - Khayelitsha
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Responsible Party: COVID-19 Prevention Network
ClinicalTrials.gov Identifier: NCT04431414    
Other Study ID Numbers: CoVPN 5001
5UM1AI068614-14 ( U.S. NIH Grant/Contract )
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No