SARS-CoV-2 InfectionSALICOVNCT04578509
Evaluation of a Screening Program for SARS-CoV-2 Infection in the General Population Based on the Use of New Detection Approaches or for Diagnostic Orientation on Saliva
An observational study of SARS-CoV-2 Infection and COVID-19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The investigators hypothesize that detection of SARS-CoV2 on saliva samples will increase the performance of the screening program compared to the reference strategy (RT-PCR on a nasopharyngeal swab). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SARS-CoV-2 Infection, COVID-19
- What is being tested?
- Nasopharyngeal swab, Saliva sample and axillary sweat sample
- How many people
- 5,197 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2020to 9 Jun 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Ambulatory adults or children requiring screening for SARS-CoV-2 by nasopharyngeal swab
Who may be able to join
- Adult or child subject able to receive nasopharyngeal swab, regardless of age
- Subject in whom nasopharyngeal swab is performed for detection of SARS-CoV-2 as part of the screening system managed by APHP
- Subject or parent not opposed to saliva sampling and data collection as part of this research
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site
SARS-CoV-2 screening device of Assistance Publique des Hôpitaux de Paris (AP-HP)
Paris, 75001
About this study
Official title: Evaluation of a Screening Program for SARS-CoV-2 Infection in the General Population Based on the Use of New Detection Approaches or for Diagnostic Orientation on Saliva (COVID-19)
The investigators hypothesize that detection of SARS-CoV2 on saliva samples will increase the performance of the screening program compared to the reference strategy (RT-PCR on a nasopharyngeal swab).
Read the detailed description
Containment of the COVID19 pandemic relies on mass screening to allow rapid identification and isolation of cases to break transmission chains. The reference diagnostic method is based on detection of viral genomes by PCR on a nasopharyngeal swab sample (NPS).
However, the pandemic has generated a very high demand causing a shortage of specific swabs and difficulties in the supply of reagents and consumables. Nasopharyngeal sampling requires skilled personnel, and is sometimes poorly accepted by patients. These issues can reduce the quality of sampling and therefore the sensitivity of the test. This strategy also requires sending samples to specialized laboratories, generating a delay in providing results.
New diagnostic approaches on saliva samples are being developed allowing 1) an easier sampling procedure and 2) a diagnostic technique that can be performed in point-of-care.
Previous evaluations suggest that these approaches have a lower sensitivity than the reference strategy (PCR on NPS), around 50 to 90% depending on the technique used.
Despite lower sensitivity compared to the reference strategy, the investigators hypothesize that detection of SARS-CoV2 on saliva samples will improve the performance of the screening program by considerably increasing the number of individuals tested in shorter times.
The main objective of the study is to evaluate, for the detection of SARS-CoV-2 infection, the performance of various alternative virological diagnostic strategies on saliva samples, in comparison with the reference technique (RT-PCR on NPS).
The primary endpoint of the study is positivity of the standard technique (RT-PCR on NPS) for the SARS-CoV-2 virus. The result of the alternative strategies on a saliva sample will be considered as positive or negative according to criteria specific to each of them and compared to the result of the reference technique to estimate their respective sensitivity.
The secondary objectives are to compare the diagnostic performances of RT-PCR on saliva versus RT-PCR on NPS, the diagnostic performances of alternative techniques on saliva versus RT-PCR on saliva, to evaluate the acceptability of the saliva self-sampling and the cost-effectiveness of new diagnostic strategies compared to the reference technique.
The study will include adults and children in whom a NPS is performed for SARS-CoV-2 screening. After informed consent, participants will be asked to provide a saliva sample before nasopharyngeal sampling. Both samples will be analyzed in parallel. The analytical performance of each technique will be assessed, centrally or delocalised, depending on the feasibility of the techniques and according to the advice of the scientific board. The analyzes will be carried out by a team of technicians specifically recruited for the study. All samples collected will be stored in a centralized in a biobank.
- Conditions
- SARS-CoV-2 Infection, COVID-19
- Being tested
- Nasopharyngeal swab, Saliva sample, axillary sweat sample, Data collection
- Keywords
- Screening program, SARS-CoV-2 infection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal swabDiagnostic test
Research of SARS-CoV-2 infection in nasopharyngeal swab by RT-PCR and by antigenic test
Saliva sampleDiagnostic test
Research of SARS-CoV-2 infection in saliva samples by RT-PCR and by new detection approach
axillary sweat sampleDiagnostic test
Research of volatile olfactory compounds of SARS-CoV-2 infection by canine detection on axillary sweat.
Data collectionOther
Demographics, symptoms, medical history, acceptability of specimen, consumption in precedents hours are collected
| Study group | Role | What they receive |
|---|---|---|
| Salicov | Ambulatory adults or children requiring screening for SARS-CoV-2 by nasopharyngeal swab Receives: Diagnostic Test: Nasopharyngeal swab; Diagnostic Test: Saliva sample; Diagnostic Test: axillary sweat sample; Other: Data collection | |
| SalicovII (ancillary study) | Ancillar study : Children and teachers / staff from middle and high schools in Ile de France Saliva samples is collected as part of care. Only a self-rated questionnaire is collected. Receives: Diagnostic Test: Saliva sample; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positivity of RT-PCR on nasopharyngeal swab for the SARS-CoV-2 virus
RT-PCR on nasopharyngeal is considered as gold standard
Measured: At diagnosis
Secondary outcomes (14)
Positivity of RT-PCR on saliva sample for the SARS-CoV-2 virus
Measured: At diagnosis
Positivity of new detection approach on saliva sample for the SARS-CoV-2 virus
Measured: At diagnosis
Positivity of antigenic test on nasopharyngeal swab for the SARS-CoV-2 virus
Measured: At diagnosis
Practicability to samples
Number of samples tested in a day for each test
Measured: At diagnosis
Practicability to premises
Quantity of premises required for each test
Measured: At diagnosis
Practicability to interpretation
Feasibly Reading and interpretation For each test
Measured: At diagnosis
Practicability to render time
Render times for each test
Measured: At diagnosis
IgG Antibody detection in saliva
Research of IgG by ELISA and RDT
Measured: At diagnosis
IgM Antibody detection in saliva
Research of IgM by ELISA and RDT
Measured: At diagnosis
IgA Antibody detection in saliva
Research of IgA by ELISA and RDT
Measured: At diagnosis
Positivity of canine olfactory detection of SARS-CoV-2
Measured: At diagnosis
Patient tolerance of the salivary self-sampling
Evaluation by questionnaire of the patient tolerance of the salivary self-sampling compared to the nasopharyngeal swab (questions are about pain, discomfort, speed of performance)
Measured: At diagnosis
Operator tolerance of the salivary self-sampling
Evaluation by questionnaire of the operator tolerance of the salivary self-sampling compared to the nasopharyngeal swab (questions is about pain, discomfort, speed of performance)
Measured: At diagnosis
Cost of each approach
Including sampling, transport, technique (consumables, reagents, machine), human resources
Measured: At diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start19 Oct 2020
- Primary completion9 Jun 2021
- Study completion9 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 5,197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Jérôme Le Goff, Professor, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578509
- Sponsor's protocol ID
- APHP200960
- Other IDs
- 2020-A02431-38
- Acronym
- SALICOV
- Status last verified
- Mar 2026
- First submitted
- 21 Sep 2020
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, Yip CC, Cai JP, Chan JM, Chik TS, Lau DP, Choi CY, Chen LL, Chan WM, Chan KH, Ip JD, Ng AC, Poon RW, Luo CT, Cheng VC, Chan JF, Hung IF, Chen Z, Chen H, Yuen KY. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May;20(5):565-574. doi: 10.1016/S1473-3099(20)30196-1. Epub 2020 Mar 23.
PubMed 32213337Lai CKC, Chen Z, Lui G, Ling L, Li T, Wong MCS, Ng RWY, Tso EYK, Ho T, Fung KSC, Ng ST, Wong BKC, Boon SS, Hui DSC, Chan PKS. Prospective Study Comparing Deep Throat Saliva With Other Respiratory Tract Specimens in the Diagnosis of Novel Coronavirus Disease 2019. J Infect Dis. 2020 Oct 13;222(10):1612-1619. doi: 10.1093/infdis/jiaa487.
PubMed 32738137Chen JH, Yip CC, Poon RW, Chan KH, Cheng VC, Hung IF, Chan JF, Yuen KY, To KK. Evaluating the use of posterior oropharyngeal saliva in a point-of-care assay for the detection of SARS-CoV-2. Emerg Microbes Infect. 2020 Dec;9(1):1356-1359. doi: 10.1080/22221751.2020.1775133.
PubMed 32459137Rao M, Rashid FA, Sabri FSAH, Jamil NN, Zain R, Hashim R, Amran F, Kok HT, Samad MAA, Ahmad N. Comparing Nasopharyngeal Swab and Early Morning Saliva for the Identification of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2021 May 4;72(9):e352-e356. doi: 10.1093/cid/ciaa1156.
PubMed 32761244Landry ML, Criscuolo J, Peaper DR. Challenges in use of saliva for detection of SARS CoV-2 RNA in symptomatic outpatients. J Clin Virol. 2020 Sep;130:104567. doi: 10.1016/j.jcv.2020.104567. Epub 2020 Jul 31.
PubMed 32750665Migueres M, Mengelle C, Dimeglio C, Didier A, Alvarez M, Delobel P, Mansuy JM, Izopet J. Saliva sampling for diagnosing SARS-CoV-2 infections in symptomatic patients and asymptomatic carriers. J Clin Virol. 2020 Sep;130:104580. doi: 10.1016/j.jcv.2020.104580. Epub 2020 Aug 5. No abstract available.
PubMed 32781366To KK, Tsang OT, Yip CC, Chan KH, Wu TC, Chan JM, Leung WS, Chik TS, Choi CY, Kandamby DH, Lung DC, Tam AR, Poon RW, Fung AY, Hung IF, Cheng VC, Chan JF, Yuen KY. Consistent Detection of 2019 Novel Coronavirus in Saliva. Clin Infect Dis. 2020 Jul 28;71(15):841-843. doi: 10.1093/cid/ciaa149.
PubMed 32047895Williams E, Bond K, Zhang B, Putland M, Williamson DA. Saliva as a Noninvasive Specimen for Detection of SARS-CoV-2. J Clin Microbiol. 2020 Jul 23;58(8):e00776-20. doi: 10.1128/JCM.00776-20. Print 2020 Jul 23. No abstract available.
PubMed 32317257McCormick-Baw C, Morgan K, Gaffney D, Cazares Y, Jaworski K, Byrd A, Molberg K, Cavuoti D. Saliva as an Alternate Specimen Source for Detection of SARS-CoV-2 in Symptomatic Patients Using Cepheid Xpert Xpress SARS-CoV-2. J Clin Microbiol. 2020 Jul 23;58(8):e01109-20. doi: 10.1128/JCM.01109-20. Print 2020 Jul 23. No abstract available.
PubMed 32414838Jamal AJ, Mozafarihashjin M, Coomes E, Powis J, Li AX, Paterson A, Anceva-Sami S, Barati S, Crowl G, Faheem A, Farooqi L, Khan S, Prost K, Poutanen S, Taylor M, Yip L, Zhong XZ, McGeer AJ, Mubareka S; Toronto Invasive Bacterial Diseases Network COVID-19 Investigators. Sensitivity of Nasopharyngeal Swabs and Saliva for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2. Clin Infect Dis. 2021 Mar 15;72(6):1064-1066. doi: 10.1093/cid/ciaa848.
PubMed 32584972Lambert-Niclot S, Cuffel A, Le Pape S, Vauloup-Fellous C, Morand-Joubert L, Roque-Afonso AM, Le Goff J, Delaugerre C. Evaluation of a Rapid Diagnostic Assay for Detection of SARS-CoV-2 Antigen in Nasopharyngeal Swabs. J Clin Microbiol. 2020 Jul 23;58(8):e00977-20. doi: 10.1128/JCM.00977-20. Print 2020 Jul 23. No abstract available.
PubMed 32404480Azzi L, Baj A, Alberio T, Lualdi M, Veronesi G, Carcano G, Ageno W, Gambarini C, Maffioli L, Saverio SD, Gasperina DD, Genoni AP, Premi E, Donati S, Azzolini C, Grandi AM, Dentali F, Tangianu F, Sessa F, Maurino V, Tettamanti L, Siracusa C, Vigezzi A, Monti E, Iori V, Iovino D, Ietto G; ASST dei Sette Laghi Rapid Salivary Test Nurse staff Research Group; Grossi PA, Tagliabue A, Fasano M. Rapid Salivary Test suitable for a mass screening program to detect SARS-CoV-2: A diagnostic accuracy study. J Infect. 2020 Sep;81(3):e75-e78. doi: 10.1016/j.jinf.2020.06.042. Epub 2020 Jun 21. No abstract available.
PubMed 32579988Angle C, Waggoner LP, Ferrando A, Haney P, Passler T. Canine Detection of the Volatilome: A Review of Implications for Pathogen and Disease Detection. Front Vet Sci. 2016 Jun 24;3:47. doi: 10.3389/fvets.2016.00047. eCollection 2016.
PubMed 27446935Jendrny P, Schulz C, Twele F, Meller S, von Kockritz-Blickwede M, Osterhaus ADME, Ebbers J, Pilchova V, Pink I, Welte T, Manns MP, Fathi A, Ernst C, Addo MM, Schalke E, Volk HA. Scent dog identification of samples from COVID-19 patients - a pilot study. BMC Infect Dis. 2020 Jul 23;20(1):536. doi: 10.1186/s12879-020-05281-3.
PubMed 32703188Grandjean D, Sarkis R, Lecoq-Julien C, Benard A, Roger V, Levesque E, Bernes-Luciani E, Maestracci B, Morvan P, Gully E, Berceau-Falancourt D, Haufstater P, Herin G, Cabrera J, Muzzin Q, Gallet C, Bacque H, Broc JM, Thomas L, Lichaa A, Moujaes G, Saliba M, Kuhn A, Galey M, Berthail B, Lapeyre L, Capelli A, Renault S, Bachir K, Kovinger A, Comas E, Stainmesse A, Etienne E, Voeltzel S, Mansouri S, Berceau-Falancourt M, Dami A, Charlet L, Ruau E, Issa M, Grenet C, Billy C, Tourtier JP, Desquilbet L. Can the detection dog alert on COVID-19 positive persons by sniffing axillary sweat samples? A proof-of-concept study. PLoS One. 2020 Dec 10;15(12):e0243122. doi: 10.1371/journal.pone.0243122. eCollection 2020.
PubMed 33301539
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Screening Program for SARS-CoV-2 Infection in the General Population Based on the Use of New Detection Approaches or for Diagnostic Orientation on Saliva (COVID-19)
- ClinicalTrials.gov ID
- NCT04578509
- Acronym / sponsor ID
- SALICOV / APHP200960
- Conditions
- SARS-CoV-2 Infection, COVID-19
- Keywords
- Screening program, SARS-CoV-2 infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,197 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 8 Oct 2020 (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.
The investigators hypothesize that detection of SARS-CoV2 on saliva samples will increase the performance of the screening program compared to the reference strategy (RT-PCR on a nasopharyngeal swab).
Detailed description
Containment of the COVID19 pandemic relies on mass screening to allow rapid identification and isolation of cases to break transmission chains. The reference diagnostic method is based on detection of viral genomes by PCR on a nasopharyngeal swab sample (NPS).
However, the pandemic has generated a very high demand causing a shortage of specific swabs and difficulties in the supply of reagents and consumables. Nasopharyngeal sampling requires skilled personnel, and is sometimes poorly accepted by patients. These issues can reduce the quality of sampling and therefore the sensitivity of the test. This strategy also requires sending samples to specialized laboratories, generating a delay in providing results.
New diagnostic approaches on saliva samples are being developed allowing 1) an easier sampling procedure and 2) a diagnostic technique that can be performed in point-of-care.
Previous evaluations suggest that these approaches have a lower sensitivity than the reference strategy (PCR on NPS), around 50 to 90% depending on the technique used.
Despite lower sensitivity compared to the reference strategy, the investigators hypothesize that detection of SARS-CoV2 on saliva samples will improve the performance of the screening program by considerably increasing the number of individuals tested in shorter times.
The main objective of the study is to evaluate, for the detection of SARS-CoV-2 infection, the performance of various alternative virological diagnostic strategies on saliva samples, in comparison with the reference technique (RT-PCR on NPS).
The primary endpoint of the study is positivity of the standard technique (RT-PCR on NPS) for the SARS-CoV-2 virus. The result of the alternative strategies on a saliva sample will be considered as positive or negative according to criteria specific to each of them and compared to the result of the reference technique to estimate their respective sensitivity.
The secondary objectives are to compare the diagnostic performances of RT-PCR on saliva versus RT-PCR on NPS, the diagnostic performances of alternative techniques on saliva versus RT-PCR on saliva, to evaluate the acceptability of the saliva self-sampling and the cost-effectiveness of new diagnostic strategies compared to the reference technique.
The study will include adults and children in whom a NPS is performed for SARS-CoV-2 screening. After informed consent, participants will be asked to provide a saliva sample before nasopharyngeal sampling. Both samples will be analyzed in parallel. The analytical performance of each technique will be assessed, centrally or delocalised, depending on the feasibility of the techniques and according to the advice of the scientific board. The analyzes will be carried out by a team of technicians specifically recruited for the study. All samples collected will be stored in a centralized in a biobank.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salicov | – | Diagnostic Test: Nasopharyngeal swab, Diagnostic Test: Saliva sample, Diagnostic Test: axillary sweat sample, Other: Data collectionAmbulatory adults or children requiring screening for SARS-CoV-2 by nasopharyngeal swab |
| SalicovII (ancillary study) | – | Diagnostic Test: Saliva sample, Other: Data collectionAncillar study : Children and teachers / staff from middle and high schools in Ile de France Saliva samples is collected as part of care. Only a self-rated questionnaire is collected. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ambulatory adults or children requiring screening for SARS-CoV-2 by nasopharyngeal swab
Key inclusion criteria (3 listed)
- Adult or child subject able to receive nasopharyngeal swab, regardless of age
- Subject in whom nasopharyngeal swab is performed for detection of SARS-CoV-2 as part of the screening system managed by APHP
- Subject or parent not opposed to saliva sampling and data collection as part of this research
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Nasopharyngeal swabResearch of SARS-CoV-2 infection in nasopharyngeal swab by RT-PCR and by antigenic test | Diagnostic test | Salicov |
| Saliva sampleResearch of SARS-CoV-2 infection in saliva samples by RT-PCR and by new detection approach | Diagnostic test | Salicov, SalicovII (ancillary study) |
| axillary sweat sampleResearch of volatile olfactory compounds of SARS-CoV-2 infection by canine detection on axillary sweat. | Diagnostic test | Salicov |
| Data collectionDemographics, symptoms, medical history, acceptability of specimen, consumption in precedents hours are collected | Other | Salicov, SalicovII (ancillary study) |
Primary outcome
Positivity of RT-PCR on nasopharyngeal swab for the SARS-CoV-2 virus
Time frame: At diagnosis
RT-PCR on nasopharyngeal is considered as gold standard
14 secondary outcomes
Positivity of RT-PCR on saliva sample for the SARS-CoV-2 virus
Time frame: At diagnosis
Positivity of new detection approach on saliva sample for the SARS-CoV-2 virus
Time frame: At diagnosis
Positivity of antigenic test on nasopharyngeal swab for the SARS-CoV-2 virus
Time frame: At diagnosis
Practicability to samples
Time frame: At diagnosis
Practicability to premises
Time frame: At diagnosis
Practicability to interpretation
Time frame: At diagnosis
Practicability to render time
Time frame: At diagnosis
IgG Antibody detection in saliva
Time frame: At diagnosis
IgM Antibody detection in saliva
Time frame: At diagnosis
IgA Antibody detection in saliva
Time frame: At diagnosis
Positivity of canine olfactory detection of SARS-CoV-2
Time frame: At diagnosis
Patient tolerance of the salivary self-sampling
Time frame: At diagnosis
Operator tolerance of the salivary self-sampling
Time frame: At diagnosis
Cost of each approach
Time frame: At diagnosis
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 2026.
- Background: PubMed 32213337To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, Yip CC, Cai JP, Chan JM, Chik TS, Lau DP, Choi CY, Chen LL, Chan WM, Chan KH, Ip JD, Ng AC, Poon RW, Luo CT, Cheng VC, Chan JF, Hung IF, Chen Z, Chen H, Yuen KY. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May;20(5):565-574. doi: 10.1016/S1473-3099(20)30196-1. Epub 2020 Mar 23.
- Background: PubMed 32738137Lai CKC, Chen Z, Lui G, Ling L, Li T, Wong MCS, Ng RWY, Tso EYK, Ho T, Fung KSC, Ng ST, Wong BKC, Boon SS, Hui DSC, Chan PKS. Prospective Study Comparing Deep Throat Saliva With Other Respiratory Tract Specimens in the Diagnosis of Novel Coronavirus Disease 2019. J Infect Dis. 2020 Oct 13;222(10):1612-1619. doi: 10.1093/infdis/jiaa487.
- Background: PubMed 32459137Chen JH, Yip CC, Poon RW, Chan KH, Cheng VC, Hung IF, Chan JF, Yuen KY, To KK. Evaluating the use of posterior oropharyngeal saliva in a point-of-care assay for the detection of SARS-CoV-2. Emerg Microbes Infect. 2020 Dec;9(1):1356-1359. doi: 10.1080/22221751.2020.1775133.
- Background: PubMed 32761244Rao M, Rashid FA, Sabri FSAH, Jamil NN, Zain R, Hashim R, Amran F, Kok HT, Samad MAA, Ahmad N. Comparing Nasopharyngeal Swab and Early Morning Saliva for the Identification of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2021 May 4;72(9):e352-e356. doi: 10.1093/cid/ciaa1156.
- Background: PubMed 32750665Landry ML, Criscuolo J, Peaper DR. Challenges in use of saliva for detection of SARS CoV-2 RNA in symptomatic outpatients. J Clin Virol. 2020 Sep;130:104567. doi: 10.1016/j.jcv.2020.104567. Epub 2020 Jul 31.
- Background: PubMed 32781366Migueres M, Mengelle C, Dimeglio C, Didier A, Alvarez M, Delobel P, Mansuy JM, Izopet J. Saliva sampling for diagnosing SARS-CoV-2 infections in symptomatic patients and asymptomatic carriers. J Clin Virol. 2020 Sep;130:104580. doi: 10.1016/j.jcv.2020.104580. Epub 2020 Aug 5. No abstract available.
- Background: PubMed 32047895To KK, Tsang OT, Yip CC, Chan KH, Wu TC, Chan JM, Leung WS, Chik TS, Choi CY, Kandamby DH, Lung DC, Tam AR, Poon RW, Fung AY, Hung IF, Cheng VC, Chan JF, Yuen KY. Consistent Detection of 2019 Novel Coronavirus in Saliva. Clin Infect Dis. 2020 Jul 28;71(15):841-843. doi: 10.1093/cid/ciaa149.
- Background: PubMed 32317257Williams E, Bond K, Zhang B, Putland M, Williamson DA. Saliva as a Noninvasive Specimen for Detection of SARS-CoV-2. J Clin Microbiol. 2020 Jul 23;58(8):e00776-20. doi: 10.1128/JCM.00776-20. Print 2020 Jul 23. No abstract available.
- Background: PubMed 32414838McCormick-Baw C, Morgan K, Gaffney D, Cazares Y, Jaworski K, Byrd A, Molberg K, Cavuoti D. Saliva as an Alternate Specimen Source for Detection of SARS-CoV-2 in Symptomatic Patients Using Cepheid Xpert Xpress SARS-CoV-2. J Clin Microbiol. 2020 Jul 23;58(8):e01109-20. doi: 10.1128/JCM.01109-20. Print 2020 Jul 23. No abstract available.
- Background: PubMed 32584972Jamal AJ, Mozafarihashjin M, Coomes E, Powis J, Li AX, Paterson A, Anceva-Sami S, Barati S, Crowl G, Faheem A, Farooqi L, Khan S, Prost K, Poutanen S, Taylor M, Yip L, Zhong XZ, McGeer AJ, Mubareka S; Toronto Invasive Bacterial Diseases Network COVID-19 Investigators. Sensitivity of Nasopharyngeal Swabs and Saliva for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2. Clin Infect Dis. 2021 Mar 15;72(6):1064-1066. doi: 10.1093/cid/ciaa848.
- Background: PubMed 32404480Lambert-Niclot S, Cuffel A, Le Pape S, Vauloup-Fellous C, Morand-Joubert L, Roque-Afonso AM, Le Goff J, Delaugerre C. Evaluation of a Rapid Diagnostic Assay for Detection of SARS-CoV-2 Antigen in Nasopharyngeal Swabs. J Clin Microbiol. 2020 Jul 23;58(8):e00977-20. doi: 10.1128/JCM.00977-20. Print 2020 Jul 23. No abstract available.
- Background: PubMed 32579988Azzi L, Baj A, Alberio T, Lualdi M, Veronesi G, Carcano G, Ageno W, Gambarini C, Maffioli L, Saverio SD, Gasperina DD, Genoni AP, Premi E, Donati S, Azzolini C, Grandi AM, Dentali F, Tangianu F, Sessa F, Maurino V, Tettamanti L, Siracusa C, Vigezzi A, Monti E, Iori V, Iovino D, Ietto G; ASST dei Sette Laghi Rapid Salivary Test Nurse staff Research Group; Grossi PA, Tagliabue A, Fasano M. Rapid Salivary Test suitable for a mass screening program to detect SARS-CoV-2: A diagnostic accuracy study. J Infect. 2020 Sep;81(3):e75-e78. doi: 10.1016/j.jinf.2020.06.042. Epub 2020 Jun 21. No abstract available.
- Individual participant dataSharing planned: No
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Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
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
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.
Jérôme Le Goff, Professor study director
Assistance Publique - Hôpitaux de Paris
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 SARS-CoV-2 Infection and COVID-19, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 1 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 2026. 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?
Positivity of RT-PCR on nasopharyngeal swab for the SARS-CoV-2 virus (time frame: At diagnosis). 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 NCT04578509, which also lists 17 linked publications.
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 2026.