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

COVID-19 Clinical Trial

— CoVPN 5001  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04431414
• Other study ID #: CoVPN 5001
• Secondary ID: 5UM1AI068614-14
• Status: Completed
• Start date: July 20, 2020
• Est. completion date: June 2, 2022

Study information

• Verified date: July 2022
• Source: COVID-19 Prevention Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 953
• Est. completion date: June 2, 2022
• Est. primary completion date: June 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Other:
• Sample collection
blood, nasal swab, nasal wash, and saliva optional stool swab

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
COVID-19 Prevention Network	National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Zambia,  Zimbabwe,  Argentina,  Botswana,  Brazil,  Malawi,  Mexico,  Peru,  South Africa,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Response rate of SARS-CoV-2-specific antibody binding in serum samples	Measured by binding antibody multiplex assay (BAMA)	Measured through day 28
Primary	Response rate of SARS-CoV-2-specific neutralizing antibodies in serum samples	Measured by neutralizing antibody assay (nAb)	Measured through day 28
Primary	Magnitude of SARS-CoV-2-specific antibody binding antibodies in serum samples	Measured by binding antibody multiplex assay (BAMA)	Measured through day 28
Primary	Magnitude of SARS-CoV-2-specific neutralizing antibodies in serum samples	Measured by neutralizing antibody assay (nAb)	Measured through day 28
Primary	Response rate of SARS-CoV-2-specific binding antibodies in nasal wash samples	Measured by binding antibody multiplex assay (BAMA)	Measured through day 28
Primary	Magnitude of SARS-CoV-2-specific binding antibodies in nasal wash samples	Measured by binding antibody multiplex assay (BAMA)	Measured through day 28
Primary	Frequency of leukocyte populations in peripheral blood	Measured by flow cytometry	Measured through day 14
Primary	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
Primary	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
Primary	Response rate of SARS-CoV-2-specific CD4+ and CD8+ T cells	Measured by flow cytometry	Measured through day 28
Primary	Magnitude of SARS-CoV-2-specific CD4+ and CD8+ T cells	Measured by flow cytometry	Measured through day 28
Primary	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	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