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

NCT04703114 | Completed

• 2 other identifiers: APHP2012852020-A03102-37
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; SARS-CoV-2

Keywords

Covid19; SARS-CoV-2; Immunology

Outcome Measures

Primary Outcomes (1)

• Interferon response

  Concentration of type I, type II and type III Interferon in peripheral blood

  Up to 90 days

Secondary Outcomes (10)

• Immunology : cytokines

  Up to 90 days

• Immunology : cell population

  Up to 90 days

• Immunology : proteins

  Up to 90 days

• Immunology : pathways

  Up to 90 days

• Immunology : antibody response

  Up to 90 days

Study Arms (2)

Symptomatic

EXPERIMENTAL

40 symptomatic patients to COVID-19 infection

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

Asymptomatic

EXPERIMENTAL

40 asymptomatic patients to COVID-19 infection

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

Interventions

Blood count DIAGNOSTIC_TEST

Blood count at each visit

Asymptomatic; Symptomatic

Blood collection DIAGNOSTIC_TEST

Blood collection to understanding of the immunological profile at each visit

Asymptomatic; Symptomatic

Saliva samples DIAGNOSTIC_TEST

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

Asymptomatic; Symptomatic

Faeces samples DIAGNOSTIC_TEST

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

Asymptomatic; Symptomatic

Genetic blood collection GENETIC

Collection to further research at each visit

Asymptomatic; Symptomatic

Data collection OTHER

Demographics, symptoms, biological constants

Asymptomatic; Symptomatic

Nasopharyngeal swab DIAGNOSTIC_TEST

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

Asymptomatic; Symptomatic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fonds IMMUNOV: collaborator
• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Cochin

Paris, Île-de-France Region, 75014, France

Location

Related Publications (5)

• 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.

  PMID: 31978945 BACKGROUND

• 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.

  PMID: 32105632 BACKGROUND

• 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.

  PMID: 32661059 BACKGROUND

• 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.

  PMID: 32717743 BACKGROUND

• 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.

  PMID: 37795693 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Blood Cell Count; Blood Specimen Collection; Data Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Specimen Handling; Punctures; Surgical Procedures, Operative; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Solen KERNEIS, Doctor

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: January 11, 2021
• Study Start: February 5, 2021
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: March 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)