Study of the Immunological and Virological Response of Patients With COVID-19 and Presenting an Asymptomatic or Pauci-symptomatic Form (AMBUCOV)
NCT ID: NCT04703114
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2021-02-05
2021-09-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Symptomatic
40 symptomatic patients to COVID-19 infection
Blood count
Blood count at each visit
Blood collection
Blood collection to understanding of the immunological profile at each visit
Nasopharyngeal swab
Research of SARS-CoV-2 infection in nasopharyngeal swab by RT-PCR at day 8 and day 15
Saliva samples
Research of SARS-CoV-2 infection in saliva samples at each visit (excepted inclusion)
Faeces samples
Research of SARS-CoV-2 infection in faeces samples at day 3, day 15 and day 90
Genetic blood collection
Collection to further research at each visit
Data collection
Demographics, symptoms, biological constants
Asymptomatic
40 asymptomatic patients to COVID-19 infection
Blood count
Blood count at each visit
Blood collection
Blood collection to understanding of the immunological profile at each visit
Nasopharyngeal swab
Research of SARS-CoV-2 infection in nasopharyngeal swab by RT-PCR at day 8 and day 15
Saliva samples
Research of SARS-CoV-2 infection in saliva samples at each visit (excepted inclusion)
Faeces samples
Research of SARS-CoV-2 infection in faeces samples at day 3, day 15 and day 90
Genetic blood collection
Collection to further research at each visit
Data collection
Demographics, symptoms, biological constants
Interventions
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Blood count
Blood count at each visit
Blood collection
Blood collection to understanding of the immunological profile at each visit
Nasopharyngeal swab
Research of SARS-CoV-2 infection in nasopharyngeal swab by RT-PCR at day 8 and day 15
Saliva samples
Research of SARS-CoV-2 infection in saliva samples at each visit (excepted inclusion)
Faeces samples
Research of SARS-CoV-2 infection in faeces samples at day 3, day 15 and day 90
Genetic blood collection
Collection to further research at each visit
Data collection
Demographics, symptoms, biological constants
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Fonds IMMUNOV
UNKNOWN
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Solen KERNEIS, Doctor
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Cochin
Paris, Île-de-France Region, France
Countries
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References
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Lingas G, Planas D, Pere H, Porrot F, Guivel-Benhassine F, Staropoli I, Duffy D, Chapuis N, Gobeaux C, Veyer D, Delaugerre C, Le Goff J, Getten P, Hadjadj J, Bellino A, Parfait B, Treluyer JM, Schwartz O, Guedj J, Kerneis S, Terrier B. Neutralizing Antibody Levels as a Correlate of Protection Against SARS-CoV-2 Infection: A Modeling Analysis. Clin Pharmacol Ther. 2024 Jan;115(1):86-94. doi: 10.1002/cpt.3069. Epub 2023 Oct 20.
Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
Hadjadj J, Yatim N, Barnabei L, Corneau A, Boussier J, Smith N, Pere H, Charbit B, Bondet V, Chenevier-Gobeaux C, Breillat P, Carlier N, Gauzit R, Morbieu C, Pene F, Marin N, Roche N, Szwebel TA, Merkling SH, Treluyer JM, Veyer D, Mouthon L, Blanc C, Tharaux PL, Rozenberg F, Fischer A, Duffy D, Rieux-Laucat F, Kerneis S, Terrier B. Impaired type I interferon activity and inflammatory responses in severe COVID-19 patients. Science. 2020 Aug 7;369(6504):718-724. doi: 10.1126/science.abc6027. Epub 2020 Jul 13.
Lucas C, Wong P, Klein J, Castro TBR, Silva J, Sundaram M, Ellingson MK, Mao T, Oh JE, Israelow B, Takahashi T, Tokuyama M, Lu P, Venkataraman A, Park A, Mohanty S, Wang H, Wyllie AL, Vogels CBF, Earnest R, Lapidus S, Ott IM, Moore AJ, Muenker MC, Fournier JB, Campbell M, Odio CD, Casanovas-Massana A; Yale IMPACT Team; Herbst R, Shaw AC, Medzhitov R, Schulz WL, Grubaugh ND, Dela Cruz C, Farhadian S, Ko AI, Omer SB, Iwasaki A. Longitudinal analyses reveal immunological misfiring in severe COVID-19. Nature. 2020 Aug;584(7821):463-469. doi: 10.1038/s41586-020-2588-y. Epub 2020 Jul 27.
Other Identifiers
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2020-A03102-37
Identifier Type: OTHER
Identifier Source: secondary_id
AMBUCOV
Identifier Type: -
Identifier Source: org_study_id
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