COVID-19Phase 4NCT05148949
Study on Three Doses of an Inactivated COVID-19 Vaccine in Chinese Pulmonary Tuberculosis Patients
A Phase 4 study testing Standard dosage inactivated vaccine and Double dosage inactivated vaccine in people with COVID-19 and Pulmonary Tuberculosis, run by Jiangsu Province Centers for Disease Control and Prevention at 6 sites in China.
Trial summary
This is a randomized, double-blind, parallel-controlled study, for evaluation of safety and immunogenicity of three doses of an inactivated COVID-19 vaccine (CoronaVac) in pulmonary tuberculosis patients aged 18-75 years. 200 tuberculosis patients and 40 healthy adults aged 18-75 years will be recruited in this study. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Pulmonary Tuberculosis
- What is being tested?
- Standard dosage inactivated vaccine and Double dosage inactivated vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 6 sitesChina
- Study dates
- 22 Dec 2021to 10 Mar 2023
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pulmonary tuberculosis patients aged 18-75 years who have not received COVID-19 vaccine.
- The condition is determined to be stable by the clinician.
- The subjects can provide with informed consent and sign informed consent form (ICF).
- The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the follow-up of the study.
- Axillary temperature ≤ 37.0℃.
- 1.Healthy subjects aged 18-75 years who have not received COVID-19 vaccine. 2.The subjects can provide with informed consent and sign informed consent form (ICF).
Show all 27Show fewer
- 3.The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the follow-up of the study.
- 4.Axillary temperature ≤ 37.0℃. Exclusion criteria for the first vaccination
- Medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.
- HIV positive.
- Cancer patients under treatment.
- Allergic to any component of the research vaccines, or a history of hypersensitivity or serious reactions to vaccination.
- Women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan in this study.
- Severe chronic diseases or condition in progress cannot be controlled.( Grade 3 or higher as defined in the guidelines for the classification of adverse events in clinical trials for prophylactic vaccines).
- Transaminase ≥ 3 times ULN or total bilirubin ≥2 times ULN, or other serious adverse reactions as determined by the clinician for antituberculosis treatment.
- Congenital or acquired angioedema / neuroedema.
- Asplenia or functional asplenia.
- Thrombocytopenia or other clotting disorder (this may contraindicate intramuscular injection).
- Immunosuppressant therapy, antiallergic therapy, cytotoxic therapy, high dose inhaled corticosteroid over the past 6 months (excluding corticosteroid spray for allergic rhinitis, surface corticosteroid for acute non-complicated dermatitis, and corticosteroid with dose less than 20mg/ day)
- Received blood products within 4 months before vaccination.
- Received other investigational drugs within 1 month prior to receiving the investigational vaccines.
- Received other live attenuated vaccines within 1 month prior to receiving the investigational vaccines.
- Received subunit or inactivated vaccine within 14 days prior to receiving investigational vaccine.
- Any medical, psychological, social or other conditions that, in the investigator's judgment, are inconsistent with the study protocol or affect the subjects' informed consent Exclusion criteria for subsequent vaccination
- 1.Those who have had a severe allergic reaction after a previous dose of vaccine.
- 2.Serious adverse events causally related to the previous vaccination. 3.The newly discovered or newly emerging cases who don't meet the inclusion criteria or meet the exclusion criteria for the first dose, the investigator will decide whether they will continue to participate in the study.
- 4.Other reasons the investigator consider for exclusion.
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Huai'an No.4 People's Hospital
Huai'an, Jiangsu, 223001
Jing-Xin Li, Ph.D, #86-25-83759913, jingxin42102209@126.com
- Recruiting
Taizhou People's Hospital
Taizhou, Jiangsu, 225300
Jing-Xin Li, Ph.D, #86-25-83759913, jingxin42102209@126.com
- Recruiting
Wuxi No.5 People's Hospital
Wuxi, Jiangsu, 214000
Jing-Xin Li, Ph.D, #86-25-83759913, jingxin42102209@126.com
- Recruiting
Xuzhou Infectious Disease Hospital
Xuzhou, Jiangsu, 221000
Jing-Xin Li, PhD, #86-25-83759913, jingxin42102209@126.com
Jing-Xin Li, PhD
- Recruiting
Binhai County Hospital of Chinese medicine
Yancheng, Jiangsu, 224000
Jing-Xin Li, Ph.D, #86-25-83759913, jingxin42102209@126.com
- Recruiting
Danyang Center for Disease Control and Prevention
Zhenjiang, Jiangsu, 212300
Jing-Xin Li, Ph.D, #86-25-83759913, jingxin42102209@126.com
About this study
Official title: Safety and Immunogenicity of Three Doses of an Inactivated SARS-CoV-2 Vaccine in Chinese Pulmonary Tuberculosis Patients Aged 18-75 Years: a Randomized, Double-blind, Parallel-controlled Clinical Trial
This is a randomized, double-blind, parallel-controlled study, for evaluation of safety and immunogenicity of three doses of an inactivated COVID-19 vaccine (CoronaVac) in pulmonary tuberculosis patients aged 18-75 years. 200 tuberculosis patients and 40 healthy adults aged 18-75 years will be recruited in this study. Of them, 200 pulmonary tuberculosis patients will be randomized at a 1:1 ratio to receive two doses of standard dosage CoronaVac plus one dose of double dosage CoronaVac or two doses of standard dosage CoronaVac plus one dose of standard dosage CoronaVac at a schedule of 0, 28, 56 days, respectively. Other 40 healthy subjects served as an external control group will be vaccinated with two doses of standard dosage CoronaVac at a schedule of 0, 28 days. The occurrence of adverse events within 28 days after each dose vaccination and serious adverse events within 3 months after full vaccination will be observed. In addition, blood samples will be collected on day 0 before the first dose and 28 days and 3 months after the last dose vaccination in all participants and 28 days after second dose in pulmonary tuberculosis patients. Each subject will remain in this study for 5 months (healthy group) or 6 months (tuberculosis group).
- Conditions
- COVID-19, Pulmonary Tuberculosis
- Being tested
- Standard dosage inactivated vaccine, Double dosage inactivated vaccine
- Medical subject headings
- COVID-19, Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard dosage inactivated vaccineBiological
Also called Standard dosage CoronaVac
This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research \& Development Co., Ltd. 0.5 ml / bottle.
Double dosage inactivated vaccineBiological
Also called Double dosage CoronaVac
This vaccine contains 1200 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research \& Development Co., Ltd. 0.5 ml / bottle.
| Study group | Role | What they receive |
|---|---|---|
| Investigational vaccine group 1 | Experimental | 100 tuberculosis patients will receive two doses of standard dosage CoronaVac plus one dose of double dosage CoronaVac at a schedule of 0, 28, 56 days. Receives: Biological: Standard dosage inactivated vaccine; Biological: Double dosage inactivated vaccine |
| Investigational vaccine group 2 | Experimental | 100 tuberculosis patients will receive two doses of standard dosage CoronaVac plus one dose of standard dosage CoronaVac at a schedule of 0, 28, 56 days. Receives: Biological: Standard dosage inactivated vaccine; Biological: Double dosage inactivated vaccine |
| Standard regimen group | Active comparator | 40 healthy subjects will receive two doses of standard dosage CoronaVac at a schedule of 0, 28 days. Receives: Biological: Standard dosage inactivated vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse reaction within 28 days after each dose
Incidence of adverse reaction within 28 days after each dose.
Measured: within 28 days after each dose
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the second dose.
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the second dose.
Measured: On day 28 after the second dose
Secondary outcomes (8)
Incidence of solicited adverse events within 7 days after each dose.
Incidence of solicited adverse events within 7 days after each dose.
Measured: within 7 days after each dose
Incidence of adverse events within 28 days after each dose.
Incidence of adverse events within 28 days after each dose.
Measured: within 28 days after each dose
Incidence of unsolicited adverse events within 28 days after each dose.
Incidence of unsolicited adverse events within 28 days after each dose.
Measured: within 28 days after each dose
Incidence of serious adverse events (SAE) till the 3 months after the last vaccination.
Incidence of serious adverse events (SAE) till the 3 months after the last vaccination.
Measured: within 3 months after the last vaccination
GMT of anti-S protein of SARS-CoV-2 binding antibodies on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients.
GMT of anti-S protein of SARS-CoV-2 binding antibodies measured by ELISA on day 28 and month 3 after the last dose in all groups and day 28 after second dose in tuberculosis patients.
Measured: on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients
Fold increase of anti-S protein of SARS-CoV-2 binding antibodies on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients.
Fold increase of anti-S protein of SARS-CoV-2 binding antibodies on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients.
Measured: on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 3 after the last dose in pulmonary tuberculosis patients.
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 3 after the last dose in pulmonary tuberculosis patients.
Measured: on day 28 and month 3 after the last dose in pulmonary tuberculosis patients
8. Fold increase of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients.
Fold increase of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients.
Measured: on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start22 Dec 2021
- Primary completion10 Dec 2022 (estimated)
- Study completion10 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pulmonary tuberculosis patients will be randomized at a 1:1 ratio to receive two doses of standard dosage CoronaVac plus one dose of double dosage CoronaVac or two doses of standard dosage CoronaVac plus one dose of standard dosage CoronaVac at a schedule of 0, 28, 56 days, respectively. Healthy subjects served as an external control group will be vaccinated with two doses of standard dosage CoronaVac at a schedule of 0, 28 days.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jing-Xin Li, PhD, Principal investigator, Jiangsu Provincial Center for Diseases Control and PreventionLi-mei Zhu, Principal investigator, Jiangsu Provincial Center for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148949
- Sponsor's protocol ID
- JSVCT134
- Status last verified
- Dec 2021
- First submitted
- 3 Dec 2021
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang Z, Jin P, Nie X, Wei J, Jia S, Liu Q, Wei M, Ding X, Zhou D, Zhu L, Zhu L, Du M, Li J. Dissociation between humoral and multi-omic immune responses to inactivated COVID-19 vaccination in patients with pulmonary tuberculosis. Front Immunol. 2026 Sep 18;17:1933038. doi: 10.3389/fimmu.2026.1933038. eCollection 2026.
PubMed 42827549Jin P, Liu Q, Chen W, Guo X, Jiang H, Zhang R, Ding M, Zhang K, Cao Z, He J, Jia S, Wei M, Hu Y, Cui L, Wang J, Li Z, Zhang X, Xia X, Wu Y, Zhou L, Zhu Y, Gao C, Zhang T, Zhu F, Zeng G, Zhu L, Li J. Immunogenicity and safety of two-dose or three-dose regimens of inactivated COVID-19 vaccines in patients with pulmonary tuberculosis: a randomised clinical trial. Expert Rev Vaccines. 2024 Jan-Dec;23(1):1041-1051. doi: 10.1080/14760584.2024.2425283. Epub 2024 Nov 11.
PubMed 39523878
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Three Doses of an Inactivated SARS-CoV-2 Vaccine in Chinese Pulmonary Tuberculosis Patients Aged 18-75 Years: a Randomized, Double-blind, Parallel-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05148949
- Acronym / sponsor ID
- JSVCT134
- Conditions
- COVID-19, Pulmonary Tuberculosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 10 Dec 2022 (estimated)
- Study completion
- 10 Mar 2023 (estimated)
- First posted
- 8 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.
This is a randomized, double-blind, parallel-controlled study, for evaluation of safety and immunogenicity of three doses of an inactivated COVID-19 vaccine (CoronaVac) in pulmonary tuberculosis patients aged 18-75 years. 200 tuberculosis patients and 40 healthy adults aged 18-75 years will be recruited in this study. Of them, 200 pulmonary tuberculosis patients will be randomized at a 1:1 ratio to receive two doses of standard dosage CoronaVac plus one dose of double dosage CoronaVac or two doses of standard dosage CoronaVac plus one dose of standard dosage CoronaVac at a schedule of 0, 28, 56 days, respectively. Other 40 healthy subjects served as an external control group will be vaccinated with two doses of standard dosage CoronaVac at a schedule of 0, 28 days. The occurrence of adverse events within 28 days after each dose vaccination and serious adverse events within 3 months after full vaccination will be observed. In addition, blood samples will be collected on day 0 before the first dose and 28 days and 3 months after the last dose vaccination in all participants and 28 days after second dose in pulmonary tuberculosis patients. Each subject will remain in this study for 5 months (healthy group) or 6 months (tuberculosis group).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Pulmonary tuberculosis patients will be randomized at a 1:1 ratio to receive two doses of standard dosage CoronaVac plus one dose of double dosage CoronaVac or two doses of standard dosage CoronaVac plus one dose of standard dosage CoronaVac at a schedule of 0, 28, 56 days, respectively. Healthy subjects served as an external control group will be vaccinated with two doses of standard dosage CoronaVac at a schedule of 0, 28 days.
| Arm | Type | Receives |
|---|---|---|
| Investigational vaccine group 1 | Experimental | Biological: Standard dosage inactivated vaccine, Biological: Double dosage inactivated vaccine100 tuberculosis patients will receive two doses of standard dosage CoronaVac plus one dose of double dosage CoronaVac at a schedule of 0, 28, 56 days. |
| Investigational vaccine group 2 | Experimental | Biological: Standard dosage inactivated vaccine, Biological: Double dosage inactivated vaccine100 tuberculosis patients will receive two doses of standard dosage CoronaVac plus one dose of standard dosage CoronaVac at a schedule of 0, 28, 56 days. |
| Standard regimen group | Active comparator | Biological: Standard dosage inactivated vaccine40 healthy subjects will receive two doses of standard dosage CoronaVac at a schedule of 0, 28 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Pulmonary tuberculosis patients aged 18-75 years who have not received COVID-19 vaccine.
- The condition is determined to be stable by the clinician.
- The subjects can provide with informed consent and sign informed consent form (ICF).
- The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the follow-up of the study.
- Axillary temperature ≤ 37.0℃.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Standard dosage inactivated vaccineAlso: Standard dosage CoronaVacThis vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research \& Development Co., Ltd. 0.5 ml / bottle. | Biological | Investigational vaccine group 1, Investigational vaccine group 2, Standard regimen group |
| Double dosage inactivated vaccineAlso: Double dosage CoronaVacThis vaccine contains 1200 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research \& Development Co., Ltd. 0.5 ml / bottle. | Biological | Investigational vaccine group 1, Investigational vaccine group 2 |
Primary outcome
Incidence of adverse reaction within 28 days after each dose
Time frame: within 28 days after each dose
Incidence of adverse reaction within 28 days after each dose.
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the second dose.
Time frame: On day 28 after the second dose
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the second dose.
8 secondary outcomes
Incidence of solicited adverse events within 7 days after each dose.
Time frame: within 7 days after each dose
Incidence of adverse events within 28 days after each dose.
Time frame: within 28 days after each dose
Incidence of unsolicited adverse events within 28 days after each dose.
Time frame: within 28 days after each dose
Incidence of serious adverse events (SAE) till the 3 months after the last vaccination.
Time frame: within 3 months after the last vaccination
GMT of anti-S protein of SARS-CoV-2 binding antibodies on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients.
Time frame: on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients
Fold increase of anti-S protein of SARS-CoV-2 binding antibodies on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients.
Time frame: on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 3 after the last dose in pulmonary tuberculosis patients.
Time frame: on day 28 and month 3 after the last dose in pulmonary tuberculosis patients
8. Fold increase of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients.
Time frame: on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Derived from this study: PubMed 42827549Jiang Z, Jin P, Nie X, Wei J, Jia S, Liu Q, Wei M, Ding X, Zhou D, Zhu L, Zhu L, Du M, Li J. Dissociation between humoral and multi-omic immune responses to inactivated COVID-19 vaccination in patients with pulmonary tuberculosis. Front Immunol. 2026 Sep 18;17:1933038. doi: 10.3389/fimmu.2026.1933038. eCollection 2026.
- Derived from this study: PubMed 39523878Jin P, Liu Q, Chen W, Guo X, Jiang H, Zhang R, Ding M, Zhang K, Cao Z, He J, Jia S, Wei M, Hu Y, Cui L, Wang J, Li Z, Zhang X, Xia X, Wu Y, Zhou L, Zhu Y, Gao C, Zhang T, Zhu F, Zeng G, Zhu L, Li J. Immunogenicity and safety of two-dose or three-dose regimens of inactivated COVID-19 vaccines in patients with pulmonary tuberculosis: a randomised clinical trial. Expert Rev Vaccines. 2024 Jan-Dec;23(1):1041-1051. doi: 10.1080/14760584.2024.2425283. Epub 2024 Nov 11.
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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.
Jing-Xin Li, PhD principal investigator
Jiangsu Provincial Center for Diseases Control and Prevention
Li-mei Zhu principal investigator
Jiangsu Provincial Center for Diseases Control and Prevention
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard dosage inactivated vaccine and Double dosage inactivated vaccine in people with COVID-19 and Pulmonary Tuberculosis, run by Jiangsu Province Centers for Disease Control and Prevention at 6 sites in China.
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 27 inclusion and 0 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 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jing-Xin Li, PhD (#86-25-83759913, jingxin42102209@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse reaction within 28 days after each dose (time frame: within 28 days after each dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05148949, which also lists 2 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 16 Aug 2022.