Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of the Immunological and Virological Response of Patients With COVID-19 and Presenting an Asymptomatic or Pauci-symptomatic Form (AMBUCOV) (AMBUCOV)

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: NCT04703114
Recruitment Status : Not yet recruiting
First Posted : January 11, 2021
Last Update Posted : January 11, 2021
Sponsor:
Collaborator:
Fonds IMMUNOV
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The purpose of this study is to describe the immunological and virological response of patients infected with CoV-2-SARS and presenting an asymptomatic or mildly symptomatic form, in particular the innate and adaptive response as well as the virological clearance kinetics.

The research hypothesis is that patients with an ambulatory form of SARS-CoV-2 infection, whether asymptomatic or mildly symptomatic, are able to mount an innate and adaptive immunological response capable of rapidly clearing the virus, in contrast to severe forms in which an early deficit of type 1 IFN response has been demonstrated, possibly responsible for a defect in the control of viral replication in the blood.


Condition or disease Intervention/treatment Phase
Covid19 SARS-CoV-2 Diagnostic Test: Blood count Diagnostic Test: Blood collection Diagnostic Test: Nasopharyngeal swab Diagnostic Test: Saliva samples Diagnostic Test: Faeces samples Genetic: Genetic blood collection Other: Data collection Not Applicable

Detailed Description:

A new coronavirus (SARS-CoV-2) was identified in December 2019 in the Wuhan region of China and is currently causing a global pandemic.

The disease, named COVID-19, causes an influenza syndrome associated with respiratory signs, but there are also asymptomatic and pauci-symptomatic forms. Approximately 2 to 3% of patients, primarily patients with pre-existing chronic diseases and the elderly, develop a very severe form responsible for an acute respiratory distress syndrome (ARDS) that can lead to death.

It has been shown that patients with a severe and critical form had an impaired type 1 interferon response, with decreased plasma levels of IFN-alpha2 in the most severe patients compared to hospitalized patients with a moderate form, and undetectable levels of IFN-beta. This lack of type 1 IFN response was associated with greater viral persistence in the blood and an exaggerated inflammatory response mediated primarily by the NF-kB pathway.

Almost all studies published to date on immune system disruption during CoV-2-SARS infection included mainly hospitalized patients requiring oxygen therapy due to their severity, assessed at the time of clinical worsening.

Thus, there is no or little data on immunological response profiles, particularly on type 1 IFN response but also on other aspects of the immunological response (adaptive cellular and humoral immunity), and its relationship with viral clearance kinetics during ambulatory forms of SARS-CoV-2 infection, whereas these forms represent more than 95% of the clinical forms.

The asymptomatic and pauci-symptomatic forms managed on an outpatient basis represent the most common form of CoV-2-SARS infection, with a favourable outcome in almost all cases.

A better description and understanding of the immunological profile, including type 1 IFN response and viral clearance kinetics in saliva, blood and feces, during asymptomatic and mild clinical forms will allow the identification of the major players in the immune response against SARS-CoV-2, and thus better define the responses that are lacking in severe patients.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of the Immunological and Virological Response of Patients Infected With SARS-CoV-2 and Presenting an Asymptomatic or Pauci-symptomatic Form
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Symptomatic
40 symptomatic patients to COVID-19 infection
Diagnostic Test: Blood count
Blood count at each visit

Diagnostic Test: Blood collection
Blood collection to understanding of the immunological profile at each visit

Diagnostic Test: Nasopharyngeal swab
Research of SARS-CoV-2 infection in nasopharyngeal swab by RT-PCR at day 8 and day 15

Diagnostic Test: Saliva samples
Research of SARS-CoV-2 infection in saliva samples at each visit (excepted inclusion)

Diagnostic Test: Faeces samples
Research of SARS-CoV-2 infection in faeces samples at day 3, day 15 and day 90

Genetic: Genetic blood collection
Collection to further research at each visit

Other: Data collection
Demographics, symptoms, biological constants

Experimental: Asymptomatic
40 asymptomatic patients to COVID-19 infection
Diagnostic Test: Blood count
Blood count at each visit

Diagnostic Test: Blood collection
Blood collection to understanding of the immunological profile at each visit

Diagnostic Test: Nasopharyngeal swab
Research of SARS-CoV-2 infection in nasopharyngeal swab by RT-PCR at day 8 and day 15

Diagnostic Test: Saliva samples
Research of SARS-CoV-2 infection in saliva samples at each visit (excepted inclusion)

Diagnostic Test: Faeces samples
Research of SARS-CoV-2 infection in faeces samples at day 3, day 15 and day 90

Genetic: Genetic blood collection
Collection to further research at each visit

Other: Data collection
Demographics, symptoms, biological constants




Primary Outcome Measures :
  1. Interferon response [ Time Frame: Up to 90 days ]
    Concentration of type I, type II and type III Interferon in peripheral blood


Secondary Outcome Measures :
  1. Immunology : cytokines [ Time Frame: Up to 90 days ]
    Concentration of IL-6, TNF-alpha, IL-8, calprotectin in peripheral blood

  2. Immunology : cell population [ Time Frame: Up to 90 days ]
    Proportions of monocytes, B cells and T cells in peripheral blood

  3. Immunology : proteins [ Time Frame: Up to 90 days ]
    Concentration of anaphylatoxins C3a and C5a in peripheral blood

  4. Immunology : pathways [ Time Frame: Up to 90 days ]
    Screening for genetic mutations involved in the interferon pathway

  5. Immunology : antibody response [ Time Frame: Up to 90 days ]
    Concentration of antibodies directed against spike protein and nucleocapsids

  6. Virology : Nasopharyngeal Viral clearance kinetics [ Time Frame: Up to 90 days ]
    Viral clearance kinetics in nasopharyngeal samples

  7. Virology : Saliva Viral clearance kinetics [ Time Frame: Up to 90 days ]
    Viral clearance kinetics in saliva

  8. Virology : faeces viral clearance kinetics [ Time Frame: Up to 90 days ]
    Viral clearance kinetics in faeces

  9. Virology : peripheral blood viral clearance kinetics [ Time Frame: Up to 90 days ]
    Viral clearance kinetics in peripheral blood

  10. Virology : sequencing [ Time Frame: Up to 90 days ]
    Analysis of virus mutations, especially of the gene encoding spike protein



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients
  • Nasopharyngeal PCR positive for SARS-CoV-2 within 48 hours prior to inclusion in the study protocol, carried out in one of the participating outpatient screening centers
  • Symptomatic patients (nasopharyngeal screening positive due to suggestive symptoms) or asymptomatic (nasopharyngeal screening positive due to screening after contact with a positive subject)
  • Patients who have been informed and signed the consent
  • Pregnant and breastfeeding women who may be included in the study.

Exclusion Criteria:

  • Patients with criteria for hospitalization at the time of diagnosis (seriousness criteria, impossibility of staying at home)
  • Non-consent or inability to obtain consent,
  • Patient with dementia or not authorized, for psychiatric reasons or intellectual failure, to receive information on the protocol and to give informed consent,
  • Patient under guardianship / curatorship

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): NCT04703114


Contacts
Layout table for location contacts
Contact: Benjamin TERRIER, professor (+33)1 58 41 14 61 benjamin.terrier@aphp.fr
Contact: Adèle BELLINO (+33)1 58 41 11 95 adele.bellino@aphp.fr

Locations
Layout table for location information
France
Hôpital Cochin
Paris, Île-de-France, France, 75014
Contact: Benjamin TERRIER, Professor    (+33)1 58 41 14 61    benjamin.terrier@aphp.fr   
Contact: Laure CHOUPEAUX, Master    (+33)1 44 38 17 11    laure.choupeaux@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Fonds IMMUNOV
Investigators
Layout table for investigator information
Study Director: Solen KERNEIS, Doctor Assistance Publique - Hôpitaux de Paris
Publications:

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04703114    
Other Study ID Numbers: AMBUCOV
2020-A03102-37 ( Other Identifier: ID-RCB )
First Posted: January 11, 2021    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Covid19
SARS-CoV-2
Immunology