SARS-CoV 2SAPRIS-SERONCT04392388

Health, Perception, Practices, Relations and Social Inequalities in the General Population During the Covid-19 Crisis

An observational study of SARS-CoV 2, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

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

Official record

Search all trials

Trial summary

This study aims to quantify and follow the cumulative incidence of SARS-CoV-2 infection in the French population using serological tests and to assess the determinants of infection from Constances, E3N-E4N, ELFE-Epipage 2 and NutriNet-Santé cohorts. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: SARS-CoV 2
What is being tested?: Non applicable
How many people: 96,883 participants
Where: 1 siteFrance
Study dates: 1 May 2020to 11 Apr 2023
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
Healthy volunteers accepted
Child, Adult, Older adult

Study population: Participants from cohorts entitled : Constances, E3N-E4N, ELFE, Epipage 2 and NutriNet-Santé

Who may be able to join

non applicable, already enrolled in the cohorts

Who cannot join

non applicable

Trial locations and contacts

1 site in 1 country.

France1 site

Inserm
Paris

Other trials in France

About this study

Official title: Health, Perception, Practices, Relations and Social Inequalities in the General Population During the Covid-19 Crisis - Serology

Read the detailed description

The primary objective is to assess the cumulative incidence of infection in the general population using dried blood spot sampling.

The secondary objectives are:

To identify factors associated with a positive SARS-CoV-2 infection (positive serology) and to characterize the durability of the serological response to SARS-CoV-2
To identify associations of symptoms predictive of a SARS-CoV-2 infection
To estimate the health care use associated with a SARS-CoV-2 infection
To estimate the fraction of sub-clinical infections or infections not captured by the healthcare system;
To study the acceptability of a mass anti-SARS-CoV-2 serological testing and the impact of its result, linked with social inequalities in health;
To estimate the individual and collective impact of containment and other preventive measures on the risk of SARS-CoV-2 infection;
To study the impact of social and territorial inequalities on seroprevalence levels.

Conditions: SARS-CoV 2
Being tested: Non applicable
Keywords: SARS-CoV2, cohort, containment, serology, prevention

What participants receive

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

Non applicableBiological
to collect data from questionnaires and to collect serological samples

Study groups in NCT04392388
Study group	Role	What they receive
SAPRIS-SERO		SAPRIS-SERO enrolls participants from cohorts entitled: Constances, E3N-E4N, ELFE, Epipage 2 and NutriNet-Santé. Receives: Biological: Non applicable

What is being measured

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

Cumulative incidence of SARS-Cov2 infection in the general population.
Simple and corrected estimate of the number of seropositive individuals/number of individuals at risk in different strata, based on weighting and calibration and taking into account the random cohort effect.
Measured: 8 months

Secondary outcomes (6)

Maintenance over time of the acquisition of anti-SARS-Cov2 antibodies
Decay kinetics estimated by mixed effect model with repeated data per subject
Measured: 8 months
Rate of use of care (medical care, hospitalization, center 15) linked to the occurrence of symptoms suggestive of a SARS-Cov2 infection, and share attributable to the infection
Rate of use of care (medical care, hospitalization, center 15) linked to the occurrence of symptoms suggestive of a SARS-Cov2 infection, and share attributable to the infection during a time frame of 8 months
Measured: 8 months
Proportion of infections without reported or pauci-symptomatic symptoms and their epidemiological and social determinants
Proportion of infections without reported or pauci-symptomatic symptoms and their epidemiological and social déterminants during a time frame of 8 months.
Measured: 8 months
Proportion of tests proposed, accepted, performed, based on social and demographic characteristics
Proportion of tests proposed, accepted, performed, based on social and demographic characteristics during a time frame of 8 months.
Measured: 8 months
Proportion and intensity of use of barrier measures (hydroalcoholic gel, mask, social distancing, description of outings / reasons, duration, frequency) and association with the level of seroprevalence
Proportion and intensity of use of barrier measures (hydroalcoholic gel, mask, social distancing, description of outings / reasons, duration, frequency) and association with the level of seroprevalence during a time frame of 8 months
Measured: 8 months
Strengths of associations between socio-behavioral factors and level of seroprevalence
Strengths of associations between socio-behavioral factors and level of seroprevalence during a time frame of 8 months
Measured: 8 months

Timeline

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

1 May 202011 Apr 2023

First posted18 May 2020
Study start1 May 2020
Primary completion31 Dec 2022
Study completion11 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for SARS-CoV 2Studies of the same condition, open and under way.
More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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: 96,883 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04392388
Sponsor's protocol ID: C20-26
Other IDs: 2020-A01195-34
Acronym: SAPRIS-SERO
Status last verified: Feb 2024
First submitted: 15 May 2020
Last updated: 10 Dec 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: IPD sharing is managed via the cohorts (Constances, E3N/E4N, NutriNetSante, Elfe/Epipage2) specific governing bodies.

Publications

Robineau O, Zins M, Touvier M, Wiernik E, Lemogne C, de Lamballerie X, Blanche H, Deleuze JF, Saba Villarroel PM, Dorival C, Nicol J, Gomes-Rima R, Correia E, Coeuret-Pellicer M, Druesne-Pecollo N, Esseddik Y, Ribet C, Goldberg M, Severi G, Carrat F; Sante, Pratiques, Relations et Inegalites Sociales en Population Generale Pendant la Crise COVID-19-Serologie (SAPRIS-SERO) Study Group. Long-lasting Symptoms After an Acute COVID-19 Infection and Factors Associated With Their Resolution. JAMA Netw Open. 2022 Nov 1;5(11):e2240985. doi: 10.1001/jamanetworkopen.2022.40985.
PubMed 36350653
Carrat F, Villarroel PMS, Lapidus N, Fourie T, Blanche H, Dorival C, Nicol J, Deleuze JF, Robineau O; SAPRIS-SERO Study Group; Touvier M, Severi G, Zins M, de Lamballerie X. Heterogeneous SARS-CoV-2 humoral response after COVID-19 vaccination and/or infection in the general population. Sci Rep. 2022 May 21;12(1):8622. doi: 10.1038/s41598-022-11787-4.
PubMed 35597776
Robineau O, Wiernik E, Lemogne C, de Lamballerie X, Ninove L, Blanche H, Deleuze JF, Ribet C, Kab S, Goldberg M, Severi G, Touvier M, Zins M, Carrat F. Persistent symptoms after the first wave of COVID-19 in relation to SARS-CoV-2 serology and experience of acute symptoms: A nested survey in a population-based cohort. Lancet Reg Health Eur. 2022 Jun;17:100363. doi: 10.1016/j.lanepe.2022.100363. Epub 2022 Apr 12.
PubMed 35434687
Carrat F, Lapidus N, Ninove L, Blanche H, Rahib D, Saba Villarroel PM, Touvier M, Severi G, Zins M, Deleuze JF, de Lamballerie X; SAPRIS-SERO study group. Age, COVID-19-like symptoms and SARS-CoV-2 seropositivity profiles after the first wave of the pandemic in France. Infection. 2022 Feb;50(1):257-262. doi: 10.1007/s15010-021-01731-5. Epub 2021 Nov 25.
PubMed 34822130
Hoze N, Paireau J, Lapidus N, Tran Kiem C, Salje H, Severi G, Touvier M, Zins M, de Lamballerie X, Levy-Bruhl D, Carrat F, Cauchemez S. Monitoring the proportion of the population infected by SARS-CoV-2 using age-stratified hospitalisation and serological data: a modelling study. Lancet Public Health. 2021 Jun;6(6):e408-e415. doi: 10.1016/S2468-2667(21)00064-5. Epub 2021 Apr 8.
PubMed 33838700
Lapidus N, Paireau J, Levy-Bruhl D, de Lamballerie X, Severi G, Touvier M, Zins M, Cauchemez S, Carrat F; SAPRIS-SERO study group. Do not neglect SARS-CoV-2 hospitalization and fatality risks in the middle-aged adult population. Infect Dis Now. 2021 Jun;51(4):380-382. doi: 10.1016/j.idnow.2020.12.007. Epub 2021 Jan 18.
PubMed 33521775
Carrat F, de Lamballerie X, Rahib D, Blanche H, Lapidus N, Artaud F, Kab S, Renuy A, Szabo de Edelenyi F, Meyer L, Lydie N, Charles MA, Ancel PY, Jusot F, Rouquette A, Priet S, Saba Villarroel PM, Fourie T, Lusivika-Nzinga C, Nicol J, Legot S, Druesne-Pecollo N, Esseddik Y, Lai C, Gagliolo JM, Deleuze JF, Bajos N, Severi G, Touvier M, Zins M; for the SAPRIS and SAPRIS-SERO study groups. Antibody status and cumulative incidence of SARS-CoV-2 infection among adults in three regions of France following the first lockdown and associated risk factors: a multicohort study. Int J Epidemiol. 2021 Nov 10;50(5):1458-1472. doi: 10.1093/ije/dyab110.
PubMed 34293141
Glemain B, Assaad C, Ghosn W, Moulaire P, de Lamballerie X, Zins M, Severi G, Touvier M, Deleuze JF; SAPRIS-SERO study group; Lapidus N, Carrat F. Revisiting the link between COVID-19 incidence and infection fatality rate during the first pandemic wave. Sci Rep. 2025 May 5;15(1):15638. doi: 10.1038/s41598-025-99078-6.
PubMed 40325150
Pignon B, Wiernik E, Ranque B, Robineau O, Carrat F, Severi G, Touvier M, Gouraud C, Ouazana Vedrines C, Pitron V, Hoertel N, Kab S, Tebeka S, Goldberg M, Zins M, Lemogne C. SARS-CoV-2 infection and the risk of depressive symptoms: a retrospective longitudinal study from the population-based CONSTANCES cohort. Psychol Med. 2024 Oct;54(14):3939-3948. doi: 10.1017/S0033291724002435. Epub 2024 Oct 14.
PubMed 39399920
Glemain B, de Lamballerie X, Zins M, Severi G, Touvier M, Deleuze JF; SAPRIS-SERO study group; Lapidus N, Carrat F. Estimating SARS-CoV-2 infection probabilities with serological data and a Bayesian mixture model. Sci Rep. 2024 Apr 25;14(1):9503. doi: 10.1038/s41598-024-60060-3.
PubMed 38664455
Charles MA, Ancel PY, Simeon T, Marchand-Martin L, Zaros C, Dufourg MN, Benhamou V, Blanche H, Deleuze JF, Rahib D, Lydie N, de Lamballerie X, Carrat F. SARS-CoV-2 seroprevalence in French 9-year-old children and their parents after the first lockdown in 2020. Front Pediatr. 2023 Oct 25;11:1274113. doi: 10.3389/fped.2023.1274113. eCollection 2023.
PubMed 37954429
Ramillon J, de Lamballerie X, Robineau O, Blanche H, Severi G, Touvier M, Zins M, Carrat F; SAPRIS-SERO study group; SAPRIS study group; Lapidus N. Correction: Antibody response, associated symptoms and profile of patients presumably infected by SARS-CoV-2 with taste or smell disorders in the SAPRIS multicohort study. BMC Infect Dis. 2023 Jul 26;23(1):492. doi: 10.1186/s12879-023-08450-2. No abstract available.
PubMed 37495960
Deschasaux-Tanguy M, Szabo de Edelenyi F, Druesne-Pecollo N, Esseddik Y, Allegre J, Srour B, Galan P, Hercberg S, Severi G, Zins M, Wiernik E; SAPRIS-SERO study group; de Lamballerie X, Carrat F, Touvier M. ABO blood types and SARS-CoV-2 infection assessed using seroprevalence data in a large population-based sample: the SAPRIS-SERO multi-cohort study. Sci Rep. 2023 Mar 23;13(1):4775. doi: 10.1038/s41598-023-30714-9.
PubMed 36959255

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?

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All SARS-CoV 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Health, Perception, Practices, Relations and Social Inequalities in the General Population During the Covid-19 Crisis - Serology
ClinicalTrials.gov ID: NCT04392388
Acronym / sponsor ID: SAPRIS-SERO / C20-26
Conditions: SARS-CoV 2
Keywords: SARS-CoV2, cohort, containment, serology, prevention
Study type: Observational
Recruitment status: Completed
Enrolment: 96,883 participants (actual)
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, FranceOther government
Study start: 1 May 2020 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 11 Apr 2023 (actual)
First posted: 18 May 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.

Detailed description

The primary objective is to assess the cumulative incidence of infection in the general population using dried blood spot sampling.

The secondary objectives are:

To identify factors associated with a positive SARS-CoV-2 infection (positive serology) and to characterize the durability of the serological response to SARS-CoV-2
To identify associations of symptoms predictive of a SARS-CoV-2 infection
To estimate the health care use associated with a SARS-CoV-2 infection
To estimate the fraction of sub-clinical infections or infections not captured by the healthcare system;
To study the acceptability of a mass anti-SARS-CoV-2 serological testing and the impact of its result, linked with social inequalities in health;
To estimate the individual and collective impact of containment and other preventive measures on the risk of SARS-CoV-2 infection;
To study the impact of social and territorial inequalities on seroprevalence levels.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
SAPRIS-SERO	–	Biological: Non applicableSAPRIS-SERO enrolls participants from cohorts entitled: Constances, E3N-E4N, ELFE, Epipage 2 and NutriNet-Santé.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Participants from cohorts entitled : Constances, E3N-E4N, ELFE, Epipage 2 and NutriNet-Santé

Key inclusion criteria (1 listed)

non applicable, already enrolled in the cohorts

Key exclusion criteria (1 listed)

non applicable

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
Non applicableto collect data from questionnaires and to collect serological samples	Biological	SAPRIS-SERO

Primary outcome

Cumulative incidence of SARS-Cov2 infection in the general population.
Time frame: 8 months
Simple and corrected estimate of the number of seropositive individuals/number of individuals at risk in different strata, based on weighting and calibration and taking into account the random cohort effect.

6 secondary outcomes

Maintenance over time of the acquisition of anti-SARS-Cov2 antibodies
Time frame: 8 months
Rate of use of care (medical care, hospitalization, center 15) linked to the occurrence of symptoms suggestive of a SARS-Cov2 infection, and share attributable to the infection
Time frame: 8 months
Proportion of infections without reported or pauci-symptomatic symptoms and their epidemiological and social determinants
Time frame: 8 months
Proportion of tests proposed, accepted, performed, based on social and demographic characteristics
Time frame: 8 months
Proportion and intensity of use of barrier measures (hydroalcoholic gel, mask, social distancing, description of outings / reasons, duration, frequency) and association with the level of seroprevalence
Time frame: 8 months
Strengths of associations between socio-behavioral factors and level of seroprevalence
Time frame: 8 months

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 10 Dec 2025.
Results publication: PubMed 36350653Robineau O, Zins M, Touvier M, Wiernik E, Lemogne C, de Lamballerie X, Blanche H, Deleuze JF, Saba Villarroel PM, Dorival C, Nicol J, Gomes-Rima R, Correia E, Coeuret-Pellicer M, Druesne-Pecollo N, Esseddik Y, Ribet C, Goldberg M, Severi G, Carrat F; Sante, Pratiques, Relations et Inegalites Sociales en Population Generale Pendant la Crise COVID-19-Serologie (SAPRIS-SERO) Study Group. Long-lasting Symptoms After an Acute COVID-19 Infection and Factors Associated With Their Resolution. JAMA Netw Open. 2022 Nov 1;5(11):e2240985. doi: 10.1001/jamanetworkopen.2022.40985.
Results publication: PubMed 35597776Carrat F, Villarroel PMS, Lapidus N, Fourie T, Blanche H, Dorival C, Nicol J, Deleuze JF, Robineau O; SAPRIS-SERO Study Group; Touvier M, Severi G, Zins M, de Lamballerie X. Heterogeneous SARS-CoV-2 humoral response after COVID-19 vaccination and/or infection in the general population. Sci Rep. 2022 May 21;12(1):8622. doi: 10.1038/s41598-022-11787-4.
Results publication: PubMed 35434687Robineau O, Wiernik E, Lemogne C, de Lamballerie X, Ninove L, Blanche H, Deleuze JF, Ribet C, Kab S, Goldberg M, Severi G, Touvier M, Zins M, Carrat F. Persistent symptoms after the first wave of COVID-19 in relation to SARS-CoV-2 serology and experience of acute symptoms: A nested survey in a population-based cohort. Lancet Reg Health Eur. 2022 Jun;17:100363. doi: 10.1016/j.lanepe.2022.100363. Epub 2022 Apr 12.
Results publication: PubMed 34822130Carrat F, Lapidus N, Ninove L, Blanche H, Rahib D, Saba Villarroel PM, Touvier M, Severi G, Zins M, Deleuze JF, de Lamballerie X; SAPRIS-SERO study group. Age, COVID-19-like symptoms and SARS-CoV-2 seropositivity profiles after the first wave of the pandemic in France. Infection. 2022 Feb;50(1):257-262. doi: 10.1007/s15010-021-01731-5. Epub 2021 Nov 25.
Results publication: PubMed 33838700Hoze N, Paireau J, Lapidus N, Tran Kiem C, Salje H, Severi G, Touvier M, Zins M, de Lamballerie X, Levy-Bruhl D, Carrat F, Cauchemez S. Monitoring the proportion of the population infected by SARS-CoV-2 using age-stratified hospitalisation and serological data: a modelling study. Lancet Public Health. 2021 Jun;6(6):e408-e415. doi: 10.1016/S2468-2667(21)00064-5. Epub 2021 Apr 8.
Results publication: PubMed 33521775Lapidus N, Paireau J, Levy-Bruhl D, de Lamballerie X, Severi G, Touvier M, Zins M, Cauchemez S, Carrat F; SAPRIS-SERO study group. Do not neglect SARS-CoV-2 hospitalization and fatality risks in the middle-aged adult population. Infect Dis Now. 2021 Jun;51(4):380-382. doi: 10.1016/j.idnow.2020.12.007. Epub 2021 Jan 18.
Results publication: PubMed 34293141Carrat F, de Lamballerie X, Rahib D, Blanche H, Lapidus N, Artaud F, Kab S, Renuy A, Szabo de Edelenyi F, Meyer L, Lydie N, Charles MA, Ancel PY, Jusot F, Rouquette A, Priet S, Saba Villarroel PM, Fourie T, Lusivika-Nzinga C, Nicol J, Legot S, Druesne-Pecollo N, Esseddik Y, Lai C, Gagliolo JM, Deleuze JF, Bajos N, Severi G, Touvier M, Zins M; for the SAPRIS and SAPRIS-SERO study groups. Antibody status and cumulative incidence of SARS-CoV-2 infection among adults in three regions of France following the first lockdown and associated risk factors: a multicohort study. Int J Epidemiol. 2021 Nov 10;50(5):1458-1472. doi: 10.1093/ije/dyab110.
Results publication: PubMed 40325150Glemain B, Assaad C, Ghosn W, Moulaire P, de Lamballerie X, Zins M, Severi G, Touvier M, Deleuze JF; SAPRIS-SERO study group; Lapidus N, Carrat F. Revisiting the link between COVID-19 incidence and infection fatality rate during the first pandemic wave. Sci Rep. 2025 May 5;15(1):15638. doi: 10.1038/s41598-025-99078-6.
Results publication: PubMed 39399920Pignon B, Wiernik E, Ranque B, Robineau O, Carrat F, Severi G, Touvier M, Gouraud C, Ouazana Vedrines C, Pitron V, Hoertel N, Kab S, Tebeka S, Goldberg M, Zins M, Lemogne C. SARS-CoV-2 infection and the risk of depressive symptoms: a retrospective longitudinal study from the population-based CONSTANCES cohort. Psychol Med. 2024 Oct;54(14):3939-3948. doi: 10.1017/S0033291724002435. Epub 2024 Oct 14.
Results publication: PubMed 38664455Glemain B, de Lamballerie X, Zins M, Severi G, Touvier M, Deleuze JF; SAPRIS-SERO study group; Lapidus N, Carrat F. Estimating SARS-CoV-2 infection probabilities with serological data and a Bayesian mixture model. Sci Rep. 2024 Apr 25;14(1):9503. doi: 10.1038/s41598-024-60060-3.
Results publication: PubMed 37954429Charles MA, Ancel PY, Simeon T, Marchand-Martin L, Zaros C, Dufourg MN, Benhamou V, Blanche H, Deleuze JF, Rahib D, Lydie N, de Lamballerie X, Carrat F. SARS-CoV-2 seroprevalence in French 9-year-old children and their parents after the first lockdown in 2020. Front Pediatr. 2023 Oct 25;11:1274113. doi: 10.3389/fped.2023.1274113. eCollection 2023.
Results publication: PubMed 37495960Ramillon J, de Lamballerie X, Robineau O, Blanche H, Severi G, Touvier M, Zins M, Carrat F; SAPRIS-SERO study group; SAPRIS study group; Lapidus N. Correction: Antibody response, associated symptoms and profile of patients presumably infected by SARS-CoV-2 with taste or smell disorders in the SAPRIS multicohort study. BMC Infect Dis. 2023 Jul 26;23(1):492. doi: 10.1186/s12879-023-08450-2. No abstract available.
Individual participant dataSharing planned: Undecided. IPD sharing is managed via the cohorts (Constances, E3N/E4N, NutriNetSante, Elfe/Epipage2) specific governing bodies.

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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.

Fabrice Carrat, MD principal investigator

Inserm - Sorbonne Université

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, run by Institut National de la Santé Et de la Recherche Médicale, France 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 1 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 10 Dec 2025. 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?

Cumulative incidence of SARS-Cov2 infection in the general population. (time frame: 8 months). 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 NCT04392388, which also lists 13 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 10 Dec 2025.