- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04640610
Angiotensin-converting Enzyme 2 (ACE2) Expression in Tonsils and Adenoids (ACE2-AVG)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Contacts and Locations
Study Locations
-
-
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Créteil, France, 94000
- Hopital Mondor
-
Le Kremlin-Bicêtre, France, 94270
- Hopital Bicetre
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Paris, France, 75010
- Hôpital Lariboisière
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Paris, France, 75020
- Hopital Tenon
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Paris, France, 75012
- Hôpital Armand Trousseau
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Paris, France, 75015
- Hôpital Necker-Enfants Malades
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Paris, France, 75013
- Hopital Pitie Salpetriere
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Paris, France, 75018
- Hopital Bichat
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Paris, France, 75015
- HEGP
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adenoidectomy / tonsillectomy
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.
|
Storage of operating waste of adenoidectomy / tonsillectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Expression of ACE 2 receptor and TMPRSS2 serine protease
Time Frame: 9 months
|
Measurement of expression of ACE 2 receptor and TMPRSS2 serine protease in tonsils and adenoids labeled by immunofluorescence.
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Location of ACE 2 receptor and TMPRSS2 serine protease
Time Frame: 9 months
|
Location of ACE 2 receptor and TMPRSS2 serine protease in tonsils and adenoids labeled by immunofluorescence.
|
9 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Romain Luscan, MD, Assistance Publique - Hôpitaux de Paris
- Study Director: Pierre-Louis Tharaux, MD, PhD, Institut National de la Santé Et de la Recherche Médicale, France
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- APHP201032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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