Respiratory Tract InfectionsCOLL001NCT04949074

Collection of RNA Extracted From Nasopharyngeal and Saliva Samples From Same Patients With Suspicion of Covid-19

An observational study of Respiratory Tract Infections, run by ID Solutions at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Constitution of a collection of SARS-CoV-2 RNA extracts from nasopharyngeal and saliva / sputum samples, from the same patients (paired samples), taken during the same consultation in an indication of detection of SARS-CoV-2 in with a view to developing tests / diagnostic tools for SARS-CoV-2. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Respiratory Tract Infections
What is being tested?: saliva sampling
How many people: 2,000 participants
Where: 1 siteFrance
Study dates: 1 Aug 2021to 15 Dec 2022
How long will I take part?: 12 Months
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Patients with an indication for SARS-CoV-2 screening

Who may be able to join

Male, female adult
Patient with an indication for SARS-CoV-2 screening.
Patient having been informed and having given his non-objection to participate in the study
Patient affiliated with a French social security scheme or beneficiary of such a scheme

Who cannot join

Pregnant or breastfeeding women
Vulnerable people Adults placed under tutorship or curatorship or under judicial protection, Patient unable to personally give consent, or adult protected by law, Opposition expressed to inclusion in the study.

Trial locations and contacts

1 site in 1 country.

France1 site

Bioaxiome
Nîmes, 30900

Other trials in France

About this study

Official title: Collection of SARS-CoV-2 RNA Extracted From Nasopharyngeal and Saliva Samples From Same Patients

Read the detailed description

In order to preserve their anonymity, the participant will be identified in a dedicated form by a unique identification number. An identification list of participants will be kept in the investigator's file. The investigator will ensure that the anonymity of each person participating in the research is guaranteed.

The source documents are the original documents, data and files from which the data concerning the participant is reported in the Data set_COLL001.xls form provided to the investigator which will serve as an observation notebook.

The investigator must agree to allow direct access to research source data during monitoring, audit or inspection visits. The source data is for the most part computerized and accessible after authorization.

The data will be transcribed into an Excel form Data set_COLL001.xls pseudonymized form which will serve as an observation book. The data will be recorded and then transmitted to ID SOLUTIONS via the Data set_COLL001.xls form provided to the investigator.

Conditions: Respiratory Tract Infections
Being tested: saliva sampling
Keywords: SARS-CoV-2, saliva, diagnostic
Medical subject headings: Respiratory Tract Infections, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

saliva samplingOther
when the patient goes to the laboratory for a covid 19 diagnostic from a routine nasopharingeal sample, an additionnal sample of saliva is asked

Study groups in NCT04949074
Study group	Role	What they receive
RNA extracted from Positive NSP samples		RNA extracted from NSP samples, found positive for the presence of SARS-CoV-2
RNA extracted from Positive saliva samples		RNA extracted from saliva samples found positive for the presence of SARS-CoV-2 Receives: Other: saliva sampling
RNA extracted from negative NSP samples		RNA extracted from NSP samples, found negative for the presence of SARS-CoV-2
RNA extracted from negative saliva samples		RNA extracted from saliva samples found negative for the presence of SARS-CoV-2 Receives: Other: saliva sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

collection of RNA extracted nasopharyngeal and saliva samples
n=130 positive n=130 negative RNA extracted from both nasopharyngeal and saliva samples from same patients sampled at the same time with suspicious COVID-19 will
Measured: up to 1 month over which the samples of each participant are collected then tested
collection of RNA extracted nasopharyngeal and saliva samples
Collection of
n=130 positive n=130 negative
RNA extracted from both nasopharyngeal and saliva samples from same patients sampled at the same time with suspicious COVID-19 will enter the collection
Measured: up to 1 month over which the samples of each participant are collected then tested

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202115 Dec 2022

First posted2 Jul 2021
Study start1 Aug 2021
Primary completion15 Dec 2022
Study completion15 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 2,000 participants (actual)
Target duration: 12 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT04949074
Sponsor's protocol ID: 2021-A00877-34
Acronym: COLL001
Status last verified: Apr 2022
First submitted: 22 Jun 2021
Last updated: 9 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: the data will not be shared to other researchers since the research is an internal collection of samples; for ID SOLUTIONS

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
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Enrolling by invitation
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Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation

All Respiratory Tract Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Collection of SARS-CoV-2 RNA Extracted From Nasopharyngeal and Saliva Samples From Same Patients
ClinicalTrials.gov ID: NCT04949074
Acronym / sponsor ID: COLL001 / 2021-A00877-34
Conditions: Respiratory Tract Infections
Keywords: SARS-CoV-2, saliva, diagnostic
Study type: Observational
Recruitment status: Completed
Enrolment: 2,000 participants (actual)
Lead sponsor: ID SolutionsIndustry (pharma, biotech, devices)
Study start: 1 Aug 2021 (actual)
Primary completion: 15 Dec 2022 (actual)
Study completion: 15 Dec 2022 (actual)
First posted: 2 Jul 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 12 Months
Number of arms: 4

Arm	Type	Receives
RNA extracted from Positive NSP samples	–	–RNA extracted from NSP samples, found positive for the presence of SARS-CoV-2
RNA extracted from Positive saliva samples	–	Other: saliva samplingRNA extracted from saliva samples found positive for the presence of SARS-CoV-2
RNA extracted from negative NSP samples	–	–RNA extracted from NSP samples, found negative for the presence of SARS-CoV-2
RNA extracted from negative saliva samples	–	Other: saliva samplingRNA extracted from saliva samples found negative for the presence of SARS-CoV-2

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Patients with an indication for SARS-CoV-2 screening

Key inclusion criteria (4 listed)

Male, female adult
Patient with an indication for SARS-CoV-2 screening.
Patient having been informed and having given his non-objection to participate in the study
Patient affiliated with a French social security scheme or beneficiary of such a scheme

Key exclusion criteria (2 listed)

Pregnant or breastfeeding women
Vulnerable people Adults placed under tutorship or curatorship or under judicial protection, Patient unable to personally give consent, or adult protected by law, Opposition expressed to inclusion in the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
saliva samplingwhen the patient goes to the laboratory for a covid 19 diagnostic from a routine nasopharingeal sample, an additionnal sample of saliva is asked	Other	RNA extracted from Positive saliva samples, RNA extracted from negative saliva samples

Primary outcome

collection of RNA extracted nasopharyngeal and saliva samples
Time frame: up to 1 month over which the samples of each participant are collected then tested
n=130 positive n=130 negative RNA extracted from both nasopharyngeal and saliva samples from same patients sampled at the same time with suspicious COVID-19 will
collection of RNA extracted nasopharyngeal and saliva samples
Time frame: up to 1 month over which the samples of each participant are collected then tested
Collection of n=130 positive n=130 negative RNA extracted from both nasopharyngeal and saliva samples from same patients sampled at the same time with suspicious COVID-19 will enter the collection

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
Individual participant dataSharing planned: No. the data will not be shared to other researchers since the research is an internal collection of samples; for ID SOLUTIONS

Related trials for Respiratory Tract Infections

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeremy M Bayette, Dr principal investigator

Labosud

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Tract Infections, run by ID Solutions at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

collection of RNA extracted nasopharyngeal and saliva samples (time frame: up to 1 month over which the samples of each participant are collected then tested). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04949074.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.