Covid19AMBUCOVNCT04703114
Study of the Immunological and Virological Response of Patients With COVID-19 and Presenting an Asymptomatic or Pauci-symptomatic Form (AMBUCOV)
A study testing Blood count, Blood collection and Nasopharyngeal swab in people with Covid19 and SARS-CoV-2, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to describe the immunological and virological response of patients infected with CoV-2-SARS and presenting an asymptomatic or mildly symptomatic form, in particular the innate and adaptive response as well as the virological clearance kinetics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, SARS-CoV-2
- What is being tested?
- Blood count, Blood collection and Nasopharyngeal swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2021to 15 Sep 2021
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- Nasopharyngeal PCR positive for SARS-CoV-2 within 48 hours prior to inclusion in the study protocol, carried out in one of the participating outpatient screening centers
- Symptomatic patients (nasopharyngeal screening positive due to suggestive symptoms) or asymptomatic (nasopharyngeal screening positive due to screening after contact with a positive subject)
- Patients who have been informed and signed the consent
- Pregnant and breastfeeding women who may be included in the study.
Who cannot join
- Patients with criteria for hospitalization at the time of diagnosis (seriousness criteria, impossibility of staying at home)
- Non-consent or inability to obtain consent,
- Patient with dementia or not authorized, for psychiatric reasons or intellectual failure, to receive information on the protocol and to give informed consent,
- Patient under guardianship / curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Immunological and Virological Response of Patients Infected With SARS-CoV-2 and Presenting an Asymptomatic or Pauci-symptomatic Form
The purpose of this study is to describe the immunological and virological response of patients infected with CoV-2-SARS and presenting an asymptomatic or mildly symptomatic form, in particular the innate and adaptive response as well as the virological clearance kinetics.
The research hypothesis is that patients with an ambulatory form of SARS-CoV-2 infection, whether asymptomatic or mildly symptomatic, are able to mount an innate and adaptive immunological response capable of rapidly clearing the virus, in contrast to severe forms in which an early deficit of type 1 IFN response has been demonstrated, possibly responsible for a defect in the control of viral replication in the blood.
Read the detailed description
A new coronavirus (SARS-CoV-2) was identified in December 2019 in the Wuhan region of China and is currently causing a global pandemic.
The disease, named COVID-19, causes an influenza syndrome associated with respiratory signs, but there are also asymptomatic and pauci-symptomatic forms. Approximately 2 to 3% of patients, primarily patients with pre-existing chronic diseases and the elderly, develop a very severe form responsible for an acute respiratory distress syndrome (ARDS) that can lead to death.
It has been shown that patients with a severe and critical form had an impaired type 1 interferon response, with decreased plasma levels of IFN-alpha2 in the most severe patients compared to hospitalized patients with a moderate form, and undetectable levels of IFN-beta. This lack of type 1 IFN response was associated with greater viral persistence in the blood and an exaggerated inflammatory response mediated primarily by the NF-kB pathway.
Almost all studies published to date on immune system disruption during CoV-2-SARS infection included mainly hospitalized patients requiring oxygen therapy due to their severity, assessed at the time of clinical worsening.
Thus, there is no or little data on immunological response profiles, particularly on type 1 IFN response but also on other aspects of the immunological response (adaptive cellular and humoral immunity), and its relationship with viral clearance kinetics during ambulatory forms of SARS-CoV-2 infection, whereas these forms represent more than 95% of the clinical forms.
The asymptomatic and pauci-symptomatic forms managed on an outpatient basis represent the most common form of CoV-2-SARS infection, with a favourable outcome in almost all cases.
A better description and understanding of the immunological profile, including type 1 IFN response and viral clearance kinetics in saliva, blood and feces, during asymptomatic and mild clinical forms will allow the identification of the major players in the immune response against SARS-CoV-2, and thus better define the responses that are lacking in severe patients.
- Conditions
- Covid19, SARS-CoV-2
- Being tested
- Blood count, Blood collection, Nasopharyngeal swab, Saliva samples, Faeces samples
- Keywords
- Covid19, SARS-CoV-2, Immunology
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood countDiagnostic test
Blood count at each visit
Blood collectionDiagnostic test
Blood collection to understanding of the immunological profile at each visit
Nasopharyngeal swabDiagnostic test
Research of SARS-CoV-2 infection in nasopharyngeal swab by RT-PCR at day 8 and day 15
Saliva samplesDiagnostic test
Research of SARS-CoV-2 infection in saliva samples at each visit (excepted inclusion)
Faeces samplesDiagnostic test
Research of SARS-CoV-2 infection in faeces samples at day 3, day 15 and day 90
Genetic blood collectionGenetic
Collection to further research at each visit
Data collectionOther
Demographics, symptoms, biological constants
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic | Experimental | 40 symptomatic patients to COVID-19 infection Receives: Diagnostic Test: Blood count; Diagnostic Test: Blood collection; Diagnostic Test: Nasopharyngeal swab; Diagnostic Test: Saliva samples; Diagnostic Test: Faeces samples; Genetic: Genetic blood collection; Other: Data collection |
| Asymptomatic | Experimental | 40 asymptomatic patients to COVID-19 infection Receives: Diagnostic Test: Blood count; Diagnostic Test: Blood collection; Diagnostic Test: Nasopharyngeal swab; Diagnostic Test: Saliva samples; Diagnostic Test: Faeces samples; Genetic: Genetic blood collection; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interferon response
Concentration of type I, type II and type III Interferon in peripheral blood
Measured: Up to 90 days
Secondary outcomes (10)
Immunology : cytokines
Concentration of IL-6, TNF-alpha, IL-8, calprotectin in peripheral blood
Measured: Up to 90 days
Immunology : cell population
Proportions of monocytes, B cells and T cells in peripheral blood
Measured: Up to 90 days
Immunology : proteins
Concentration of anaphylatoxins C3a and C5a in peripheral blood
Measured: Up to 90 days
Immunology : pathways
Screening for genetic mutations involved in the interferon pathway
Measured: Up to 90 days
Immunology : antibody response
Concentration of antibodies directed against spike protein and nucleocapsids
Measured: Up to 90 days
Virology : Nasopharyngeal Viral clearance kinetics
Viral clearance kinetics in nasopharyngeal samples
Measured: Up to 90 days
Virology : Saliva Viral clearance kinetics
Viral clearance kinetics in saliva
Measured: Up to 90 days
Virology : faeces viral clearance kinetics
Viral clearance kinetics in faeces
Measured: Up to 90 days
Virology : peripheral blood viral clearance kinetics
Viral clearance kinetics in peripheral blood
Measured: Up to 90 days
Virology : sequencing
Analysis of virus mutations, especially of the gene encoding spike protein
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start5 Feb 2021
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds IMMUNOV, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Solen KERNEIS, Doctor, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703114
- Sponsor's protocol ID
- APHP201285
- Other IDs
- 2020-A03102-37
- Acronym
- AMBUCOV
- Status last verified
- Feb 2026
- First submitted
- 30 Nov 2020
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
PubMed 31978945Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
PubMed 32105632Hadjadj J, Yatim N, Barnabei L, Corneau A, Boussier J, Smith N, Pere H, Charbit B, Bondet V, Chenevier-Gobeaux C, Breillat P, Carlier N, Gauzit R, Morbieu C, Pene F, Marin N, Roche N, Szwebel TA, Merkling SH, Treluyer JM, Veyer D, Mouthon L, Blanc C, Tharaux PL, Rozenberg F, Fischer A, Duffy D, Rieux-Laucat F, Kerneis S, Terrier B. Impaired type I interferon activity and inflammatory responses in severe COVID-19 patients. Science. 2020 Aug 7;369(6504):718-724. doi: 10.1126/science.abc6027. Epub 2020 Jul 13.
PubMed 32661059Lucas C, Wong P, Klein J, Castro TBR, Silva J, Sundaram M, Ellingson MK, Mao T, Oh JE, Israelow B, Takahashi T, Tokuyama M, Lu P, Venkataraman A, Park A, Mohanty S, Wang H, Wyllie AL, Vogels CBF, Earnest R, Lapidus S, Ott IM, Moore AJ, Muenker MC, Fournier JB, Campbell M, Odio CD, Casanovas-Massana A; Yale IMPACT Team; Herbst R, Shaw AC, Medzhitov R, Schulz WL, Grubaugh ND, Dela Cruz C, Farhadian S, Ko AI, Omer SB, Iwasaki A. Longitudinal analyses reveal immunological misfiring in severe COVID-19. Nature. 2020 Aug;584(7821):463-469. doi: 10.1038/s41586-020-2588-y. Epub 2020 Jul 27.
PubMed 32717743Lingas G, Planas D, Pere H, Porrot F, Guivel-Benhassine F, Staropoli I, Duffy D, Chapuis N, Gobeaux C, Veyer D, Delaugerre C, Le Goff J, Getten P, Hadjadj J, Bellino A, Parfait B, Treluyer JM, Schwartz O, Guedj J, Kerneis S, Terrier B. Neutralizing Antibody Levels as a Correlate of Protection Against SARS-CoV-2 Infection: A Modeling Analysis. Clin Pharmacol Ther. 2024 Jan;115(1):86-94. doi: 10.1002/cpt.3069. Epub 2023 Oct 20.
PubMed 37795693
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Immunological and Virological Response of Patients Infected With SARS-CoV-2 and Presenting an Asymptomatic or Pauci-symptomatic Form
- ClinicalTrials.gov ID
- NCT04703114
- Acronym / sponsor ID
- AMBUCOV / APHP201285
- Conditions
- Covid19, SARS-CoV-2
- Keywords
- Covid19, SARS-CoV-2, Immunology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fonds IMMUNOV, URC-CIC Paris Descartes Necker Cochin
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 11 Jan 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.
The purpose of this study is to describe the immunological and virological response of patients infected with CoV-2-SARS and presenting an asymptomatic or mildly symptomatic form, in particular the innate and adaptive response as well as the virological clearance kinetics.
The research hypothesis is that patients with an ambulatory form of SARS-CoV-2 infection, whether asymptomatic or mildly symptomatic, are able to mount an innate and adaptive immunological response capable of rapidly clearing the virus, in contrast to severe forms in which an early deficit of type 1 IFN response has been demonstrated, possibly responsible for a defect in the control of viral replication in the blood.
Detailed description
A new coronavirus (SARS-CoV-2) was identified in December 2019 in the Wuhan region of China and is currently causing a global pandemic.
The disease, named COVID-19, causes an influenza syndrome associated with respiratory signs, but there are also asymptomatic and pauci-symptomatic forms. Approximately 2 to 3% of patients, primarily patients with pre-existing chronic diseases and the elderly, develop a very severe form responsible for an acute respiratory distress syndrome (ARDS) that can lead to death.
It has been shown that patients with a severe and critical form had an impaired type 1 interferon response, with decreased plasma levels of IFN-alpha2 in the most severe patients compared to hospitalized patients with a moderate form, and undetectable levels of IFN-beta. This lack of type 1 IFN response was associated with greater viral persistence in the blood and an exaggerated inflammatory response mediated primarily by the NF-kB pathway.
Almost all studies published to date on immune system disruption during CoV-2-SARS infection included mainly hospitalized patients requiring oxygen therapy due to their severity, assessed at the time of clinical worsening.
Thus, there is no or little data on immunological response profiles, particularly on type 1 IFN response but also on other aspects of the immunological response (adaptive cellular and humoral immunity), and its relationship with viral clearance kinetics during ambulatory forms of SARS-CoV-2 infection, whereas these forms represent more than 95% of the clinical forms.
The asymptomatic and pauci-symptomatic forms managed on an outpatient basis represent the most common form of CoV-2-SARS infection, with a favourable outcome in almost all cases.
A better description and understanding of the immunological profile, including type 1 IFN response and viral clearance kinetics in saliva, blood and feces, during asymptomatic and mild clinical forms will allow the identification of the major players in the immune response against SARS-CoV-2, and thus better define the responses that are lacking in severe patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic | Experimental | Diagnostic Test: Blood count, Diagnostic Test: Blood collection, Diagnostic Test: Nasopharyngeal swab, Diagnostic Test: Saliva samples, Diagnostic Test: Faeces samples, Genetic: Genetic blood collection, Other: Data collection40 symptomatic patients to COVID-19 infection |
| Asymptomatic | Experimental | Diagnostic Test: Blood count, Diagnostic Test: Blood collection, Diagnostic Test: Nasopharyngeal swab, Diagnostic Test: Saliva samples, Diagnostic Test: Faeces samples, Genetic: Genetic blood collection, Other: Data collection40 asymptomatic patients to COVID-19 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients
- Nasopharyngeal PCR positive for SARS-CoV-2 within 48 hours prior to inclusion in the study protocol, carried out in one of the participating outpatient screening centers
- Symptomatic patients (nasopharyngeal screening positive due to suggestive symptoms) or asymptomatic (nasopharyngeal screening positive due to screening after contact with a positive subject)
- Patients who have been informed and signed the consent
- Pregnant and breastfeeding women who may be included in the study.
Key exclusion criteria (4 listed)
- Patients with criteria for hospitalization at the time of diagnosis (seriousness criteria, impossibility of staying at home)
- Non-consent or inability to obtain consent,
- Patient with dementia or not authorized, for psychiatric reasons or intellectual failure, to receive information on the protocol and to give informed consent,
- Patient under guardianship / curatorship
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 |
|---|---|---|
| Blood countBlood count at each visit | Diagnostic test | Asymptomatic, Symptomatic |
| Blood collectionBlood collection to understanding of the immunological profile at each visit | Diagnostic test | Asymptomatic, Symptomatic |
| Nasopharyngeal swabResearch of SARS-CoV-2 infection in nasopharyngeal swab by RT-PCR at day 8 and day 15 | Diagnostic test | Asymptomatic, Symptomatic |
| Saliva samplesResearch of SARS-CoV-2 infection in saliva samples at each visit (excepted inclusion) | Diagnostic test | Asymptomatic, Symptomatic |
| Faeces samplesResearch of SARS-CoV-2 infection in faeces samples at day 3, day 15 and day 90 | Diagnostic test | Asymptomatic, Symptomatic |
| Genetic blood collectionCollection to further research at each visit | Genetic | Asymptomatic, Symptomatic |
| Data collectionDemographics, symptoms, biological constants | Other | Asymptomatic, Symptomatic |
Primary outcome
Interferon response
Time frame: Up to 90 days
Concentration of type I, type II and type III Interferon in peripheral blood
10 secondary outcomes
Immunology : cytokines
Time frame: Up to 90 days
Immunology : cell population
Time frame: Up to 90 days
Immunology : proteins
Time frame: Up to 90 days
Immunology : pathways
Time frame: Up to 90 days
Immunology : antibody response
Time frame: Up to 90 days
Virology : Nasopharyngeal Viral clearance kinetics
Time frame: Up to 90 days
Virology : Saliva Viral clearance kinetics
Time frame: Up to 90 days
Virology : faeces viral clearance kinetics
Time frame: Up to 90 days
Virology : peripheral blood viral clearance kinetics
Time frame: Up to 90 days
Virology : sequencing
Time frame: Up to 90 days
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 27 Mar 2026.
- Background: PubMed 31978945Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
- Background: PubMed 32105632Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
- Background: PubMed 32661059Hadjadj J, Yatim N, Barnabei L, Corneau A, Boussier J, Smith N, Pere H, Charbit B, Bondet V, Chenevier-Gobeaux C, Breillat P, Carlier N, Gauzit R, Morbieu C, Pene F, Marin N, Roche N, Szwebel TA, Merkling SH, Treluyer JM, Veyer D, Mouthon L, Blanc C, Tharaux PL, Rozenberg F, Fischer A, Duffy D, Rieux-Laucat F, Kerneis S, Terrier B. Impaired type I interferon activity and inflammatory responses in severe COVID-19 patients. Science. 2020 Aug 7;369(6504):718-724. doi: 10.1126/science.abc6027. Epub 2020 Jul 13.
- Background: PubMed 32717743Lucas C, Wong P, Klein J, Castro TBR, Silva J, Sundaram M, Ellingson MK, Mao T, Oh JE, Israelow B, Takahashi T, Tokuyama M, Lu P, Venkataraman A, Park A, Mohanty S, Wang H, Wyllie AL, Vogels CBF, Earnest R, Lapidus S, Ott IM, Moore AJ, Muenker MC, Fournier JB, Campbell M, Odio CD, Casanovas-Massana A; Yale IMPACT Team; Herbst R, Shaw AC, Medzhitov R, Schulz WL, Grubaugh ND, Dela Cruz C, Farhadian S, Ko AI, Omer SB, Iwasaki A. Longitudinal analyses reveal immunological misfiring in severe COVID-19. Nature. 2020 Aug;584(7821):463-469. doi: 10.1038/s41586-020-2588-y. Epub 2020 Jul 27.
- Results publication: PubMed 37795693Lingas G, Planas D, Pere H, Porrot F, Guivel-Benhassine F, Staropoli I, Duffy D, Chapuis N, Gobeaux C, Veyer D, Delaugerre C, Le Goff J, Getten P, Hadjadj J, Bellino A, Parfait B, Treluyer JM, Schwartz O, Guedj J, Kerneis S, Terrier B. Neutralizing Antibody Levels as a Correlate of Protection Against SARS-CoV-2 Infection: A Modeling Analysis. Clin Pharmacol Ther. 2024 Jan;115(1):86-94. doi: 10.1002/cpt.3069. Epub 2023 Oct 20.
- Individual participant dataSharing planned: No
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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.
Solen KERNEIS, Doctor 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?
A study testing Blood count, Blood collection and Nasopharyngeal swab in people with Covid19 and SARS-CoV-2, 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 5 inclusion and 4 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 27 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?
Interferon response (time frame: Up to 90 days). 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 NCT04703114, which also lists 5 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 27 Mar 2026.