Down SyndromePRIDENCT05145348
Prospective Monitoring of Antibody Response Following COVID-19 Vaccination in Patients With Down Syndrome.
An observational study of Down Syndrome and SARS-CoV-2 Vaccination, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
The risk of severe course of SARS-CoV-2 infection in people with Down Syndrome is substantially increased. The risk of death is 3-10 fold higher than in healthy people. SARS-CoV-2 vaccines have been registered for adults and adolescents but none of them have been studied in people with Down Syndrome. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome, SARS-CoV-2 Vaccination
- What is being tested?
- Immune response to Sars-CoV-2 vaccinations; including COVID-19 vaccin Moderna, Comirnaty (Pfizer) and Vaxzevria (AstraZeneca)
- Type of treatment
- Vaccines
- How many people
- 640 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Feb 2021to 30 Jun 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Down syndrome: The patient population will either live in institutions or outside these facilitys depending on the cognitive functions and additional care needed. Children will mostly live with their parents. All participants will live in the Netherlands Healthy control: All healthy control participants will live in the Netherlands, no specific region.
Who may be able to join
- Willing to receive routine COVID-19 vaccination with Pfizer, Moderna or AstraZeneca vaccine.
- Age: ≥12 years or < 12 years once vaccine is recommended for routine use in the respective age group
- Either Down syndrome (DS) or household contacts without DS of participant with DS.
Who cannot join
- Down syndrome cohort:
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s).
- Organ transplant recipients
- Active malignancy or completion of treatment for malignancy in previous 3 months
- Infection with Human Immunodeficiency Virus (HIV)
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
Show all 11Show fewer
- Healthy control cohort:
- As in Down Syndrome cohort
- Plus:
- Active medical care for inherited or acquired immune deficiency
- Any severe comorbidity for which regular medical care is needed (e.g. heart failure, COPD, diabetes)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
UMC utrecht
Utrecht, 3584 CX
Bianca MM Streng, MD, +31650177982, b.m.m.streng-3@umcutrecht.nl
Joanne G Wildenbeest, MD, PhD, J.G.Wildenbeest-2@umcutrecht.nl
About this study
Official title: Prospective Monitoring of Antibody Response Following COVID-19 Vaccination in Patients With Down Syndrome
The risk of severe course of SARS-CoV-2 infection in people with Down Syndrome is substantially increased. The risk of death is 3-10 fold higher than in healthy people. SARS-CoV-2 vaccines have been registered for adults and adolescents but none of them have been studied in people with Down Syndrome. Vaccine responses in people with Down Syndrome are known to be suboptimal. Therefor the objective of this study is to assess the immunogenicity of SARS-CoV-2 vaccination in people with Down syndrome.
To do so, the antibody response, cellulair and mucosal immuneresponse in people with Down syndrome after the SARS-CoV-2 vaccination will be evaluated and compared to healthy controls.
Read the detailed description
All participants will receive two vaccinations against COVID-19 according to the manufacturer's instructions as part of the Dutch SARS-CoV-2 vaccination program (GGD/RIVM). To assess the immune response after vaccination, blood samples will be collected at baseline (i.e. <2 months prior to first vaccination (t=1)), 21-28 days after first vaccination and prior to second vaccination (t=2), 28 days (3-6 weeks) (t=3) and 12 (+/- 1) months (t=4) after the second vaccination. To evaluate haematological parameters, additional blood samples will be collected at baseline, 21-28 days after the first vaccination and 28 days after the second vaccination. Per visit/time-point maximum 60 ml blood will be drawn. In children the maximum amount of blood taken per visit/time-point will be 0,8 ml/kg up to 60 ml. In addition Mucosal Lining Fluid (MLF) samples will be collected at 28 days (3-6 weeks) (t=3) and 12 (+/- 1) months (t=4) after the second vaccination to evaluate the mucosal immune response after SARS-CoV-2 vaccination. In the pediatric part of the study Mucosal Lining Fluid (MLF) samples will be collected at all timepoints.
Although vaccine administration is not part of this study, vaccine type, batch number and dosing will be registered. This information will be obtained from the "COVID-vaccination information and monitoring system (CIMS)" of the RIVM.
Clinical course including the occurrence of COVID-19 will be monitored during the first year after vaccination. To evaluate vaccination related AEs, patients will be asked to collect solicited local and systemic AEs for 7 days after each vaccination using an online questionnaire, as vaccination related AEs are mainly expected in the first week after vaccination. The link to the online questionnaires will be sent to the emailaddress of the participants and/or their representative/carer. If the participants and/or their representative/carers are not able to fill out the diary online, they will be contacted by phone.
Although this study is not powered to detect differences in protection against COVID-19 between patients and controls, information on incidence of SARS-CoV-2 infection, outcome of COVID-19 will be collected up to 12 months after vaccination for descriptive purposes.
- Conditions
- Down Syndrome, SARS-CoV-2 Vaccination
- Being tested
- Immune response to Sars-CoV-2 vaccinations; including COVID-19 vaccin Moderna, Comirnaty (Pfizer) and Vaxzevria (AstraZeneca)
- Keywords
- Down Syndrome, SARS-CoV-2 vaccination, Immuneresponse
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune response to Sars-CoV-2 vaccinations; including COVID-19 vaccin Moderna, Comirnaty (Pfizer) and Vaxzevria (AstraZeneca)Biological
The vaccination is not part of the study, but part of the national immunization programme of the Netherlands. Blood will be drawn at 4 time points: baseline (t=1, <2 months prior to first vaccination); t=2: 21-28 days after first vaccination and prior to second vaccination; t=3: 28 (21-42) days after second vaccination; t=4: 12 months (+/- 1 month) after second vaccination. Mucosal Lining Fluid (MLF) samples will be collected at 28 days (3-6 weeks) (t=3) and 12 (+/- 1) months (t=4) after the second vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Down syndrome, adults | Adults and adolescents with Down syndrome >16 years old. Receives: Biological: Immune response to Sars-CoV-2 vaccinations; including COVID-19 vaccin Moderna, Comirnaty (Pfizer) and Vaxzevria (AstraZeneca) | |
| Healthy control, adults | Healthy adults and adolescents without Down syndrome > 16 years old. Without any significant comorbidities. Receives: Biological: Immune response to Sars-CoV-2 vaccinations; including COVID-19 vaccin Moderna, Comirnaty (Pfizer) and Vaxzevria (AstraZeneca) | |
| Down syndrome, children | Children with Down syndrome < 16 years old. Receives: Biological: Immune response to Sars-CoV-2 vaccinations; including COVID-19 vaccin Moderna, Comirnaty (Pfizer) and Vaxzevria (AstraZeneca) | |
| Healthy control, children | Healthy children without Down syndrome < 16 years old. Without any significant comorbidities. Receives: Biological: Immune response to Sars-CoV-2 vaccinations; including COVID-19 vaccin Moderna, Comirnaty (Pfizer) and Vaxzevria (AstraZeneca) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody based immune response to vaccination against COVID-19 28 days (t=3) after the second vaccination as compared to controls.
Participants will be classified as responders or non-responders. The definition of response will be based on the latest available data from the pivotal studies and will be defined prior to data analyses and the first database lock. The percentage of responders in the DS cohort will be compared with the percentage responders in the HS cohort.
Measured: 28 days after the second vaccination
Secondary outcomes (3)
Longevity of SARS-CoV-2 specific antibodies
Longevity of SARS-CoV-2 specific antibodies after the second vaccination will be compared between cohorts.
Measured: 1 year after the second vaccination
SARS-CoV2 specific T cell response
The number of IFN-ɣ producing SARS-CoV2 specific T cells/million PBMC (mean of 3 measures)
Measured: Number of T cells will be measured at baseline, at 21-28 days after the first vaccination and at 28 days after the second vaccination
Mucosal SARS-CoV-2 specific antibodies
Antibody titers will be compared between cohorts and with antibody titers in blood
Measured: Mucosal antibodies will be measured 28 days and 12 months after the second vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start3 Feb 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, National Institute for Public Health and the Environment (RIVM), Stichting Downsyndroom (SDS), Sanquin Research & Blood Bank Divisions
- Responsible party
- Principal investigator, Louis Bont, UMC Utrecht
- Investigators
- Louis J Bont, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145348
- Sponsor's protocol ID
- NL76336.041.21
- Acronym
- PRIDE
- Status last verified
- Dec 2021
- First submitted
- 3 Dec 2021
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hensen LCM, Streng BMM, van Wijk F, Nierkens S, Wildenbeest JG, Bont LJ, Delemarre EM; PRIDE study group. T-cell responses to primary SARS-CoV-2 vaccination in Down syndrome - From childhood to adulthood. Hum Vaccin Immunother. 2026 Dec 31;22(1):2670839. doi: 10.1080/21645515.2026.2670839. Epub 2026 Jun 1.
PubMed 42223472Streng BMM, Hensen LCM, Delemarre EM, Binnendijk RS, Smits G, den Hartog G, van der Klis FR, de Vries E, Burger JA, van Gils MJ, Coppus AMW, Weijerman ME, Lamberts R, de Graaf G, Bont LJ, Wildenbeest JG. Antibody concentration and function following SARS-CoV-2 vaccination decrease with age in adults and children with Down syndrome. Vaccine. 2026 Feb 15;73:128079. doi: 10.1016/j.vaccine.2025.128079. Epub 2025 Dec 24.
PubMed 41447779Hensen LCM, Streng BMM, van Wijk F, Nierkens S, van Binnendijk RS, Buisman AM, Coppus AMW, Geurts van Kessel CH, de Graaf G, van der Klis FR, Lamberts R, Vidarsson G, Ruckwardt TJ, de Vries E, de Vries RD, Weijerman ME, Weinberger DM, Wildenbeest JG, Bont LJ, Delemarre EM. T-cell responses to SARS-CoV-2 vaccinations in adults with Down syndrome - a prospective cohort study. Hum Vaccin Immunother. 2025 Dec;21(1):2583416. doi: 10.1080/21645515.2025.2583416. Epub 2025 Nov 6.
PubMed 41196011Streng BMM, Bont M, Delemarre EM, Binnendijk RS, Smit G, den Hartog G, Coppus AMW, de Vries E, Weijerman ME, Lamberts R, de Graaf G, van der Klis FR, Vidarsson G, Rave N, Bont LJ, Wildenbeest JG. Decreased Antibody Response After Severe Acute Respiratory Syndrome Coronavirus 2 Vaccination in Patients With Down Syndrome. J Infect Dis. 2022 Sep 4;226(4):673-677. doi: 10.1093/infdis/jiac235.
PubMed 35748853
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Monitoring of Antibody Response Following COVID-19 Vaccination in Patients With Down Syndrome
- ClinicalTrials.gov ID
- NCT05145348
- Acronym / sponsor ID
- PRIDE / NL76336.041.21
- Conditions
- Down Syndrome, SARS-CoV-2 Vaccination
- Keywords
- Down Syndrome, SARS-CoV-2 vaccination, Immuneresponse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, National Institute for Public Health and the Environment (RIVM), Stichting Downsyndroom (SDS), Sanquin Research & Blood Bank Divisions
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 6 Dec 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 risk of severe course of SARS-CoV-2 infection in people with Down Syndrome is substantially increased. The risk of death is 3-10 fold higher than in healthy people. SARS-CoV-2 vaccines have been registered for adults and adolescents but none of them have been studied in people with Down Syndrome. Vaccine responses in people with Down Syndrome are known to be suboptimal. Therefor the objective of this study is to assess the immunogenicity of SARS-CoV-2 vaccination in people with Down syndrome.
To do so, the antibody response, cellulair and mucosal immuneresponse in people with Down syndrome after the SARS-CoV-2 vaccination will be evaluated and compared to healthy controls.
Detailed description
All participants will receive two vaccinations against COVID-19 according to the manufacturer's instructions as part of the Dutch SARS-CoV-2 vaccination program (GGD/RIVM). To assess the immune response after vaccination, blood samples will be collected at baseline (i.e. <2 months prior to first vaccination (t=1)), 21-28 days after first vaccination and prior to second vaccination (t=2), 28 days (3-6 weeks) (t=3) and 12 (+/- 1) months (t=4) after the second vaccination. To evaluate haematological parameters, additional blood samples will be collected at baseline, 21-28 days after the first vaccination and 28 days after the second vaccination. Per visit/time-point maximum 60 ml blood will be drawn. In children the maximum amount of blood taken per visit/time-point will be 0,8 ml/kg up to 60 ml. In addition Mucosal Lining Fluid (MLF) samples will be collected at 28 days (3-6 weeks) (t=3) and 12 (+/- 1) months (t=4) after the second vaccination to evaluate the mucosal immune response after SARS-CoV-2 vaccination. In the pediatric part of the study Mucosal Lining Fluid (MLF) samples will be collected at all timepoints.
Although vaccine administration is not part of this study, vaccine type, batch number and dosing will be registered. This information will be obtained from the "COVID-vaccination information and monitoring system (CIMS)" of the RIVM.
Clinical course including the occurrence of COVID-19 will be monitored during the first year after vaccination. To evaluate vaccination related AEs, patients will be asked to collect solicited local and systemic AEs for 7 days after each vaccination using an online questionnaire, as vaccination related AEs are mainly expected in the first week after vaccination. The link to the online questionnaires will be sent to the emailaddress of the participants and/or their representative/carer. If the participants and/or their representative/carers are not able to fill out the diary online, they will be contacted by phone.
Although this study is not powered to detect differences in protection against COVID-19 between patients and controls, information on incidence of SARS-CoV-2 infection, outcome of COVID-19 will be collected up to 12 months after vaccination for descriptive purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Down syndrome, adults | – | Biological: Immune response to Sars-CoV-2 vaccinations; including COVID-19 vaccin Moderna, Comirnaty (Pfizer) and Vaxzevria (AstraZeneca)Adults and adolescents with Down syndrome >16 years old. |
| Healthy control, adults | – | Biological: Immune response to Sars-CoV-2 vaccinations; including COVID-19 vaccin Moderna, Comirnaty (Pfizer) and Vaxzevria (AstraZeneca)Healthy adults and adolescents without Down syndrome > 16 years old. Without any significant comorbidities. |
| Down syndrome, children | – | Biological: Immune response to Sars-CoV-2 vaccinations; including COVID-19 vaccin Moderna, Comirnaty (Pfizer) and Vaxzevria (AstraZeneca)Children with Down syndrome < 16 years old. |
| Healthy control, children | – | Biological: Immune response to Sars-CoV-2 vaccinations; including COVID-19 vaccin Moderna, Comirnaty (Pfizer) and Vaxzevria (AstraZeneca)Healthy children without Down syndrome < 16 years old. Without any significant comorbidities. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Down syndrome: The patient population will either live in institutions or outside these facilitys depending on the cognitive functions and additional care needed. Children will mostly live with their parents. All participants will live in the Netherlands Healthy control: All healthy control participants will live in the Netherlands, no specific region.
Key inclusion criteria (3 listed)
- Willing to receive routine COVID-19 vaccination with Pfizer, Moderna or AstraZeneca vaccine.
- Age: ≥12 years or < 12 years once vaccine is recommended for routine use in the respective age group
- Either Down syndrome (DS) or household contacts without DS of participant with DS.
Key exclusion criteria (11 listed)
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s).
- Organ transplant recipients
- Active malignancy or completion of treatment for malignancy in previous 3 months
- Infection with Human Immunodeficiency Virus (HIV)
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
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 |
|---|---|---|
| Immune response to Sars-CoV-2 vaccinations; including COVID-19 vaccin Moderna, Comirnaty (Pfizer) and Vaxzevria (AstraZeneca)The vaccination is not part of the study, but part of the national immunization programme of the Netherlands. Blood will be drawn at 4 time points: baseline (t=1, <2 months prior to first vaccination); t=2: 21-28 days after first vaccination and prior to second vaccination; t=3: 28 (21-42) days after second vaccination; t=4: 12 months (+/- 1 month) after second vaccination. Mucosal Lining Fluid (MLF) samples will be collected at 28 days (3-6 weeks) (t=3) and 12 (+/- 1) months (t=4) after the second vaccination. | Biological | Down syndrome, adults, Down syndrome, children, Healthy control, adults, Healthy control, children |
Primary outcome
Antibody based immune response to vaccination against COVID-19 28 days (t=3) after the second vaccination as compared to controls.
Time frame: 28 days after the second vaccination
Participants will be classified as responders or non-responders. The definition of response will be based on the latest available data from the pivotal studies and will be defined prior to data analyses and the first database lock. The percentage of responders in the DS cohort will be compared with the percentage responders in the HS cohort.
3 secondary outcomes
Longevity of SARS-CoV-2 specific antibodies
Time frame: 1 year after the second vaccination
SARS-CoV2 specific T cell response
Time frame: Number of T cells will be measured at baseline, at 21-28 days after the first vaccination and at 28 days after the second vaccination
Mucosal SARS-CoV-2 specific antibodies
Time frame: Mucosal antibodies will be measured 28 days and 12 months after the second vaccination.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- Derived from this study: PubMed 42223472Hensen LCM, Streng BMM, van Wijk F, Nierkens S, Wildenbeest JG, Bont LJ, Delemarre EM; PRIDE study group. T-cell responses to primary SARS-CoV-2 vaccination in Down syndrome - From childhood to adulthood. Hum Vaccin Immunother. 2026 Dec 31;22(1):2670839. doi: 10.1080/21645515.2026.2670839. Epub 2026 Jun 1.
- Derived from this study: PubMed 41447779Streng BMM, Hensen LCM, Delemarre EM, Binnendijk RS, Smits G, den Hartog G, van der Klis FR, de Vries E, Burger JA, van Gils MJ, Coppus AMW, Weijerman ME, Lamberts R, de Graaf G, Bont LJ, Wildenbeest JG. Antibody concentration and function following SARS-CoV-2 vaccination decrease with age in adults and children with Down syndrome. Vaccine. 2026 Feb 15;73:128079. doi: 10.1016/j.vaccine.2025.128079. Epub 2025 Dec 24.
- Derived from this study: PubMed 41196011Hensen LCM, Streng BMM, van Wijk F, Nierkens S, van Binnendijk RS, Buisman AM, Coppus AMW, Geurts van Kessel CH, de Graaf G, van der Klis FR, Lamberts R, Vidarsson G, Ruckwardt TJ, de Vries E, de Vries RD, Weijerman ME, Weinberger DM, Wildenbeest JG, Bont LJ, Delemarre EM. T-cell responses to SARS-CoV-2 vaccinations in adults with Down syndrome - a prospective cohort study. Hum Vaccin Immunother. 2025 Dec;21(1):2583416. doi: 10.1080/21645515.2025.2583416. Epub 2025 Nov 6.
- Derived from this study: PubMed 35748853Streng BMM, Bont M, Delemarre EM, Binnendijk RS, Smit G, den Hartog G, Coppus AMW, de Vries E, Weijerman ME, Lamberts R, de Graaf G, van der Klis FR, Vidarsson G, Rave N, Bont LJ, Wildenbeest JG. Decreased Antibody Response After Severe Acute Respiratory Syndrome Coronavirus 2 Vaccination in Patients With Down Syndrome. J Infect Dis. 2022 Sep 4;226(4):673-677. doi: 10.1093/infdis/jiac235.
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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.
Louis J Bont, MD, PhD principal investigator
UMC Utrecht
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 Down Syndrome and SARS-CoV-2 Vaccination, run by UMC Utrecht at 1 site in Netherlands.
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 11 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: status not confirmed, as of the sponsor's last update on 30 Dec 2021. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joanne G Wildenbeest, MD, PhD (0031887563776, J.G.Wildenbeest-2@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody based immune response to vaccination against COVID-19 28 days (t=3) after the second vaccination as compared to controls. (time frame: 28 days after the second vaccination). 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 NCT05145348, which also lists 4 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 30 Dec 2021.