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SARS-CoV-2CoVPN 5001NCT04431414

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

An observational study of SARS-CoV-2 and COVID-19, run by COVID-19 Prevention Network at 52 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
SARS-CoV-2, COVID-19
What is being tested?
Sample collection
How many people
953 participants
Where
52 sitesin 11 countries
Study dates
20 Jul 2020to 2 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.
Show all 16Show fewer
  • 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)

Who cannot join

  • 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.

Trial locations and contacts

52 sites in 11 countries.

52 sites in 11 countries

South Africa19 sites

  • Groote Schuur HIV CRS

    Cape Town

  • Khayelitsha CRS / (CIDRI UCT)

    Cape Town

  • Masiphumelele Clinical Research Site (MASI) CRS

    Cape Town

  • Chatsworth CRS

    Chatsworth

  • Botha's Hill CRS

    Durban

  • CAPRISA eThekwini CRS

    Durban

  • Vulindlela CRS

    Durban

  • Ndlovu Research Centre CoVPN CRS

    Elandsdoorn

  • Isipingo CRS

    Isipingo

  • Kliptown Soweto CRS

    Johannesburg

  • Soweto HVTN CRS

    Johannesburg

  • Aurum Institute Klerksdorp CRS

    Klerksdorp

  • Qhakaza Mbokodo Research Clinic CRS

    Ladysmith

  • MeCRU CRS

    Medunsa

  • Nelson Mandela Academic Research Unit CRS

    Mthatha

  • Rustenburg CRS

    Rustenburg

  • Setshaba Research Centre CRS

    Soshanguve

  • Tembisa Clinic 4 CoVPN CRS

    Tembisa

  • Tongaat CRS

    Tongaat

Other trials in South Africa

United States15 sites

  • The Ponce de Leon Center CRS

    Atlanta, Georgia, 30308

  • Johns Hopkins University CRS

    Baltimore, Maryland, 21205

  • Alabama CRS

    Birmingham, Alabama, 35294

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

    Boston, Massachusetts, 02115

  • Chapel Hill CRS

    Chapel Hill, North Carolina, 27599

  • Case CRS

    Cleveland, Ohio, 44106

  • The Hope Clinic of the Emory Vaccine Center CRS

    Decatur, Georgia, 30030

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

    Miami, Florida, 33136

  • New Orleans Adolescent Trials Unit CRS

    New Orleans, Louisiana, 70112

  • Columbia P&S CRS

    New York, New York, 10032

  • New York Blood Center CRS

    New York, New York, 10065

  • New Jersey Medical School Clinical Research Center CRS

    Newark, New Jersey, 07103

  • Penn Prevention CRS

    Philadelphia, Pennsylvania, 19104

  • Bridge HIV CRS

    San Francisco, California, 94143

  • Seattle Vaccine and Prevention CRS

    Seattle, Washington, 98109

Other trials in United States

Peru4 sites

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

    Bellavista

  • Asociacion Civil Selva Amazonica (ASCA) CRS

    Iquitos

  • Barranco CRS

    Lima

  • San Miguel CRS

    Lima

Other trials in Peru

Zambia3 sites

  • Matero Reference Clinic CRS

    Lusaka

  • Zambia Emory HIV Research Project - Lusaka CoVPN CRS

    Lusaka

  • Zambia Emory HIV Research Project - Ndola CoVPN CRS

    Ndola

Other trials in Zambia

Zimbabwe3 sites

  • St Mary's CRS

    Chitungwiza

  • Milton Park CRS

    Harare

  • Seke South CRS

    Harare

Other trials in Zimbabwe

Argentina2 sites

  • Fundacion Huesped CRS

    Buenos Aires

  • Hospital General de Agudos JM Ramos Mejía CRS

    Buenos Aires

Other trials in Argentina

Brazil2 sites

  • SOM Federal University Minas Gerais Brazil NICHD CRS

    Belo Horizonte

  • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

    Rio de Janeiro

Other trials in Brazil

Botswana1 site

  • Gaborone CRS

    Gaborone

Other trials in Botswana

Malawi1 site

  • Malawi CRS

    Lilongwe

Other trials in Malawi

Mexico1 site

  • Merida CRS

    Mérida

Other trials in Mexico

Tanzania1 site

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

    Mbeya

Other trials in Tanzania

About this study

Official title: 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.

Read the 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.

Conditions
SARS-CoV-2, COVID-19
Being tested
Sample collection
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sample collectionOther

    • blood, nasal swab, nasal wash, and saliva
    • optional stool swab
Study groups in NCT04431414
Study groupRoleWhat they receive
Group 1Persons that are positive for SARS-CoV-2 and are asymptomatic
Receives: Other: Sample collection
Group 2Persons that are positive for SARS-CoV-2 with recent onset of mild symptoms (not hospitalized)
Receives: Other: Sample collection
Group 3Persons that are positive for SARS-CoV-2 and are symptomatic hospitalized patients
Receives: Other: Sample collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Measured through day 14

  2. 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: Measured through day 14

  3. 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: Measured through day 14

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

    Measured by binding antibody multiplex assay (BAMA)

    Measured: Measured through day 28

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

    Measured by neutralizing antibody assay (nAb)

    Measured: Measured through day 28

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

    Measured by binding antibody multiplex assay (BAMA)

    Measured: Measured through day 28

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

    Measured by neutralizing antibody assay (nAb)

    Measured: Measured through day 28

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

    Measured by binding antibody multiplex assay (BAMA)

    Measured: Measured through day 28

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

    Measured by binding antibody multiplex assay (BAMA)

    Measured: Measured through day 28

  10. Frequency of leukocyte populations in peripheral blood

    Measured by flow cytometry

    Measured: Measured through day 14

  11. Transcriptional profiles of peripheral blood leukocytes

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

    Measured: Measured through day 14

  12. Concentration of serum cytokines and other soluble factors

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

    Measured: Measured through day 28

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

    Measured by flow cytometry

    Measured: Measured through day 28

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

    Measured by flow cytometry

    Measured: Measured through day 28

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

    Measured by flow cytometry

    Measured: Measured through day 28

Secondary outcomes (1)

  1. 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: Measured through day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start20 Jul 2020
  3. Primary completion2 Jun 2022
  4. Study completion2 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
953 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04431414
Sponsor's protocol ID
CoVPN 5001
Other IDs
5UM1AI068614-14
Acronym
CoVPN 5001
Status last verified
Jul 2022
First submitted
9 Jun 2020
Last updated
26 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-CoV-2 and COVID-19, run by COVID-19 Prevention Network at 52 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in South Africa, United States, Peru, Zambia, Zimbabwe and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate of SARS-CoV-2-specific B cells in peripheral blood samples (time frame: Measured through day 14). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04431414.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.

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