Clinical trial NCT04640610: Angiotensin-converting Enzyme 2 (ACE2) Expression in Tonsils and Adenoids
Official title: Study of the Expression of Angiotensin-converting Enzyme 2 (ACE2), a Cell Membrane Receptor for SARS-CoV-2 and the TMPRSS2 Serine Protease in Tonsils and Adenoids of Children and Adults
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Adenoidectomy
Tonsillectomy
Keywords: SARS-CoV-2
Angiotensin-converting enzyme 2 (ACE2)
Transmembrane serine protease 2 (TMPRSS2)
Tonsils
Adenoids
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adults, without SARS-CoV-2 infection, in whom an adenoidectomy and/or tonsillectomy is performed for their care in the centers of the study.

Brief summary: The objective of the research is to study the expression of the ACE 2 receptor and the TMPRSS2 serine protease in the tonsils and adenoids of children and adults.

Detailed description: The entry point for SARS-CoV-2 into the body is the nasal and pharyngeal mucosa. Angiotensin-converting enzyme 2 (ACE 2) was quickly identified as the functional receptor for SARS-CoV-2. Furthermore, the TMPRSS2 serine protease is required for the anchoring of the S protein in cell lines. In addition, the most commonly used screening test is a test for viral RNA by RT-PCR on a nasopharyngeal sample because the viral load is high.

The tonsils and adenoids could be a target organ of the virus. In order to study this hypothesis, the expression of ACE 2 and the serine protease TMPRSS2 will be sought in these tissues.

In addition, children, generally at high risk of severe viral respiratory infections (RSV, influenza), have milder symptoms than older patients with SARS-CoV-2 infection. The reason for this difference remains elusive. But one of the hypotheses formulated is that the level of expression of ACE 2 and / or TMPRSS2 may differ between adults and children, the viral load seeming to be correlated with the severity of the attack. In order to study this hypothesis, we will therefore compare the level of expression of ACE 2 in the tonsil tissue of children and adults.

Eligibility criteria: Inclusion Criteria:

* Children and adults, without SARS-CoV-2 infection, in whom an adenoidectomy and/or tonsillectomy is performed for their care in the hospitals of Assistance Publique-Hôpitaux de Paris participating in the study.
* Holders of parental authority of minor patients and adult patients not opposed to participation in the study.

Exclusion Criteria:

- N/A

Primary outcomes:
measure: Expression of ACE 2 receptor and TMPRSS2 serine protease
timeFrame: 9 months
Secondary outcomes:
measure: Location of ACE 2 receptor and TMPRSS2 serine protease
timeFrame: 9 months
Other outcomes:
Locations:
city: Créteil
country: France
facility: Hôpital Mondor
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Armand Trousseau
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
city: Paris
country: France
facility: HEGP
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
city: Paris
country: France
facility: Hôpital Bichat
city: Paris
country: France
facility: Hôpital Tenon
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Romain Luscan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Pierre-Louis Tharaux, MD, PhD
role: STUDY_DIRECTOR
References: