Cagablea: RNA Sequencing of Individual Versus Wastewater - SARS-CoV2

• Sponsor: Centre Hospitalier Universitaire de Nice (Other)
• Overall Status: Completed
• CT.gov ID: NCT05041764
• Collaborator: Centre National de la Recherche Scientifique, France (Other)
• Enrollment: 1,409
• Locations: 2
• Actual Duration (Months): 1
• Patients Per Site: 704.5
• Patients Per Site Per Month: 691.7

Study Details

Study Description

Brief Summary

The aim is to compare the percentage of the different SARS-CoV2 lineages that are detected in wastewater samples with matched clinical samples. About 1,400 swab samples from patients living in Nice were tested by Biogroup between Oct 19th and Oct 23rd (Week 43 of 2020). The sequence of 81 PCR positive samples, corresponding to all samples that were unambiguously assigned to one of the wastewater catchment areas and their lineage was determined. These values were compared to values measured in wastewater.

Condition or Disease	Intervention/Treatment	Phase
Infection Viral	Other: NO INTERVENTION

Study Design

• Study Type: Observational
• Actual Enrollment: 1409 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: A Comparison Between Individual and Wastewater SARS-CoV2 RNA Sequencing
• Actual Study Start Date: Oct 1, 2020
• Actual Primary Completion Date: Nov 1, 2020
• Actual Study Completion Date: Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
PCR positive samples that are positive for the detection of SARS-CoV2. The SARS-CoV2 sequence of positive samples is provided, together with an indication about patient's neigborhood, corresponding to one of the 21 different spots which wastewater was analyzed	Other: NO INTERVENTION; No INTERVENTION
PCR negative samples that are p negative for the detection of SARS-CoV2. T	Other: NO INTERVENTION; No INTERVENTION

Outcome Measures

Primary Outcome Measures

1. RTqPCR result [1 month]

   positive ou negative result to SAR-Cov2

2. SARS-CoV2 sequence [1 month]

   analyse of SARS-CoV2 sequence (in the case of positive samples)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• whole population tested in Nice during W43 of 2020

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nice Hospital	Nice		France	06000
2	Ipmc . Cnrs	Sophia Antipolis		France	06

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nice
• Centre National de la Recherche Scientifique, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nice
• ClinicalTrials.gov Identifier: NCT05041764
• Other Study ID Numbers: 21DSP-IPMC01
• First Posted: Sep 13, 2021
• Last Update Posted: Sep 13, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Virus Diseases

Study Results

No Results Posted as of Sep 13, 2021