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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Covid19; SARS-CoV-2

Treatments: Genetic: Genetic blood collection; Diagnostic Test: Nasopharyngeal swab; Other: Data collection; Diagnostic Test: Blood count; Diagnostic Test: Saliva samples; Diagnostic Test: Blood collection; Diagnostic Test: Faeces samples

Study type: Interventional

Funder types: Other

Identifiers

NCT04703114

AMBUCOV

2020-A03102-37 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

Symptomatic

Experimental group

Description:

40 symptomatic patients to COVID-19 infection

Treatment:

Diagnostic Test: Faeces samples

Diagnostic Test: Blood collection

Diagnostic Test: Saliva samples

Diagnostic Test: Blood count

Other: Data collection

Diagnostic Test: Nasopharyngeal swab

Genetic: Genetic blood collection

Asymptomatic

Experimental group

Description:

40 asymptomatic patients to COVID-19 infection

Treatment:

Diagnostic Test: Faeces samples

Diagnostic Test: Blood collection

Diagnostic Test: Saliva samples

Diagnostic Test: Blood count

Other: Data collection

Diagnostic Test: Nasopharyngeal swab

Genetic: Genetic blood collection