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

Study of the Immunological and Virological Response of Patients Infected With SARS-CoV-2 and Presenting an Asymptomatic or Pauci-symptomatic Form

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04703114
Acronym
AMBUCOV
Enrollment
57
Registered
2021-01-11
Start date
2021-02-05
Completion date
2021-09-15
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, SARS-CoV-2

Keywords

Covid19, SARS-CoV-2, Immunology

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.

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.

Interventions

DIAGNOSTIC_TESTBlood count

Blood count at each visit

DIAGNOSTIC_TESTBlood collection

Blood collection to understanding of the immunological profile at each visit

DIAGNOSTIC_TESTNasopharyngeal swab

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

DIAGNOSTIC_TESTSaliva samples

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

DIAGNOSTIC_TESTFaeces samples

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

GENETICGenetic blood collection

Collection to further research at each visit

OTHERData collection

Demographics, symptoms, biological constants

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
Fonds IMMUNOV
CollaboratorUNKNOWN
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Interferon responseUp to 90 daysConcentration of type I, type II and type III Interferon in peripheral blood

Secondary

MeasureTime frameDescription
Immunology : cytokinesUp to 90 daysConcentration of IL-6, TNF-alpha, IL-8, calprotectin in peripheral blood
Immunology : cell populationUp to 90 daysProportions of monocytes, B cells and T cells in peripheral blood
Immunology : proteinsUp to 90 daysConcentration of anaphylatoxins C3a and C5a in peripheral blood
Immunology : pathwaysUp to 90 daysScreening for genetic mutations involved in the interferon pathway
Immunology : antibody responseUp to 90 daysConcentration of antibodies directed against spike protein and nucleocapsids
Virology : Nasopharyngeal Viral clearance kineticsUp to 90 daysViral clearance kinetics in nasopharyngeal samples
Virology : Saliva Viral clearance kineticsUp to 90 daysViral clearance kinetics in saliva
Virology : faeces viral clearance kineticsUp to 90 daysViral clearance kinetics in faeces
Virology : peripheral blood viral clearance kineticsUp to 90 daysViral clearance kinetics in peripheral blood
Virology : sequencingUp to 90 daysAnalysis of virus mutations, especially of the gene encoding spike protein

Countries

France

Contacts

STUDY_DIRECTORSolen KERNEIS, Doctor

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026