COVID-19Phase 3NCT05398848
Efficacy, Safety and Immunogenicity Study of the Recombinant Two-component COVID-19 Vaccine (CHO Cell)(Recov)
A Phase 3 study testing Recombinant two-component COVID-19 vaccine (CHO cell) in people with COVID-19, run by Jiangsu Rec-Biotechnology Co., Ltd. at 11 sites in 2 countries.
Trial summary
This is a multicenter designed Phase III clinical trial. About 10000 participants plan to be enrolled.The objectives of this study are to evaluate the efficacy, safety and immunogenicity of the recombinant two-component COVID-19 vaccine (CHO cell) in adults Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Recombinant two-component COVID-19 vaccine (CHO cell)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7,623 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 31 Oct 2022to 29 Dec 2023
- Phase
- Phase 3
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years and older.
- Able and willing to comply with all study requirements.
- Willing to allow investigators to discuss the medical history with his/her general practitioner/personal doctors and access all medical records which are relevant to study procedures.
- Healthy adults, or adults with stable medical condition who have a pre-existing medical condition that does not meet any exclusion criteria. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
- For females of childbearing potential only, willing to practice continuous effective contraception until 90 days after the final dose vaccination, and have negative pregnancy tests before each dose vaccination.
- Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal. A follicle-stimulating hormone (FSH) level and the amenorrhea duration (e.g. amenorrhea for ≥ 12 consecutive months prior to screening without an alternative medical cause) may be measured at the discretion of investigator to confirm postmenopausal status.
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- The effective contraceptive methods include sexual abstinence or adequate contraceptive measures such as intrauterine or implanted contraceptive device, oral contraceptives, injected or implanted contraceptives, sustained-release topical contraceptives, condoms (male), diaphragm, and cervical cap, etc.
- Males participating in this study who are involved in heterosexual sexual activity must agree to practice adequate contraception (as described above) and refrain from donating sperm until 90 days after receiving the final dose vaccination.
- Agreement to refrain from blood donation during the study.
- Provide written informed consent form (ICF) prior to study enrollment.
Who cannot join
- Laboratory confirmed SARS-CoV-2 infection defined by RT-PCR assay at screening. Participants with negative result for rapid antigen testing can be enrolled before having the result of RT-PCR assay, however, the participant needs to be withdrawn the following vaccination if the RT-PCR result shows positive.
- SARS-CoV-2 antibodies (IgM or IgG) positive at screening.
- Medical history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS) and COVID-19 within 6 months prior to the randomization.
- Fever (oral temperature ≥ 37.5°C / axillary temperature ≥ 37.3°C) on the day of vaccination or within recent 72 hours.
- History of severe allergic disease or reactions likely to be exacerbated by any component of ReCOV, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopaenic purpura, local hypersensitive necrosis reaction (Arthus reaction), or prior history of serious adverse reaction to any vaccine or drug, such as allergy, urticaria eczema, dyspnea, and angioneurotic edema.
- Have malignant tumor (except for skin basal cell carcinoma or carcinoma uterine cervix in situ) and immune disease (e.g., documented human immunodeficiency virus [HIV] infection, systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy, and other immune disease that may influence immune response at investigator's discretion).
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- Have other severe and/or uncontrolled conditions, including but not limited to, acute infectious disease, cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, hematology disease, endocrine disorder, psychiatric condition and neurological illness. Uncontrolled condition is defined as significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
- Have bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.
- Received immunosuppressant or other immunomodulators, antiallergic therapy, or cytotoxicity therapy for 14 or more consecutive days within 6 months before receiving the investigational product (IP). Local administration of immunosuppressant or immunomodulator is allowed (e.g., ointment, eye drops, inhalation, or nasal spray). Drugs for local administration should not be given at a dose over the recommended level in package insert or participants should have no signs of systemic exposure.
- Administration of immunoglobulin and/or blood product within 3 months before using the IP or plan to use that during the study.
- Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e., warfarin) or novel oral anticoagulants (i.e., apixaban, rivaroxaban, dabigatran and edoxaban).
- Used other investigational drug or interventional device within 1 month before using the IP or plan to use that during the study, or are using other investigational drug or are within 5 half-lives after the last dose of the investigational drug.
- Used subunit or inactivated vaccine within 14 days before using the IP, or used attenuated live or mRNA vaccine within 1 months (30 days) before using the IP, or plan to receive any other vaccines (except for the seasonal influenza vaccine, or emergency use authorized vaccines) during the study.
- Prior receipt of an investigational or licensed COVID-19 vaccine, or investigational or approved vaccine against a coronavirus, including but not limited to SARS-CoV-1 and MERS-CoV.
- Suspected or known current alcohol or drug dependency.
- Pregnancy, lactation or willingness/intention to become pregnant within 90 days after receiving the last dose of study vaccine.
- Staff of study site, the sponsor, and contract research organization (CRO) taking part in study conduct.
- Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data at investigator's discretion.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Russia10 sites
Aramil City Hospital
Aramil
LLC Medical Service solutions
Izhevsk
'Federal State Budgetary Scientific Institution "Russian Scientific Centre of Surgery named after academician B.V. Petrovsky"
Moscow
'Joint Stock Company "Clinical and diagnostic center "Euromedservice"
Moscow
State Regional Budgetary Institution of Healthcare "Murmansk Regional Clinical Hospital named after P.A. Bayandin"
Murmansk
LLC Professorskaya klinika
Perm
UZI 4D Clinic LLC
Pyatigorsk
Klinika Zvyezdnaya LLC
Saint Petersburg
Limited Liability Company "Sfera-Med"
Saint Petersburg
Research Center Eco-safety
Saint Petersburg
About this study
Official title: A Multicenter, Randomized, Double-blinded, Placebo-controlled Phase III Trial to Evaluate the Efficacy, Safety and Immunogenicity of the Recombinant Two-component COVID-19 Vaccine (CHO Cell) in Adults Aged 18 Years and Older
This is a multicenter designed Phase III clinical trial. About 10000 participants plan to be enrolled.The objectives of this study are to evaluate the efficacy, safety and immunogenicity of the recombinant two-component COVID-19 vaccine (CHO cell) in adults
Read the detailed description
This study is a multicenter, randomized, double-blinded, placebo-controlled Phase III clinical trial. The objectives are to evaluate the efficacy, safety, and immunogenicity of ReCOV in adults aged 18 years and older who have not received any COVID-19 vaccination, and have no history of known COVID-19 in previous 6 months. Three-dose intramuscular (IM) vaccination schedule (21 days interval) will be applied.
About 10000 participants (about 15% participants ≥ 60 years old) with SARS-CoV-2 antibody (IgM and IgG) negative at baseline, will be randomized in a ratio of 1:1 to receive ReCOV (20 μg) or placebo on Day 0, Day 21, and Day 42, respectively. Participants will be stratified by age (18-59 years, ≥ 60 years) and study sites (if applicable).
For efficacy visits, study staff will contact participants on a weekly basis to remind reporting any signs or symptoms of COVID-19. If participants report any signs or symptoms that may be related to COVID-19, they will be required to immediately conduct an unscheduled visit under the instruction by site staff for COVID-19 related assessment and receiving treatment as deemed appropriate.
For reactogenicity and safety visits, all vaccinated participants will be observed for 30 minutes after each dose vaccination at study site for solicited or unsolicited AEs, and will be given subject diary to record solicited AEs within 7 days after each vaccination, and unsolicited AEs from the 1st vaccination to 28 days after the 3rd vaccination.
Approximately 600 participants will be included in the immunogenicity subgroup. Except for the efficacy and safety follow-up visits described above, this subgroup will be collected blood sample on Day 0 (pre-vaccination) and 14 days (+3 days), 90 days (±15 days) and 6 months (±15 days) after the 3rd dose.
- Conditions
- COVID-19
- Being tested
- Recombinant two-component COVID-19 vaccine (CHO cell), Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant two-component COVID-19 vaccine (CHO cell)Biological
Before reconstitution: Lyophilized powder for reconstitution in single-use vials After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter
PlaceboBiological
Before reconstitution:
Lyophilized powder for reconstitution in single-use vials
After reconstitution with BFA03 adjuvant:
Milk-white solution with no visible foreign matter
| Study group | Role | What they receive |
|---|---|---|
| Recombinant two-component COVID-19 vaccine (CHO cell) | Experimental | Antigen: NTD-RBD-foldon protein, Adjuvant (BFA03) Receives: Biological: Recombinant two-component COVID-19 vaccine (CHO cell) |
| Placebo | Placebo comparator | Adjuvant (BFA03) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of ReCOV in preventing Reverse Transcription-Polymerase Chain Reaction (RT-PCR) confirmed symptomatic COVID-19 in adults
RT-PCR confirmed symptomatic COVID-19 cases (regardless of severity) that occurred > 14 days after 3 doses vaccination.
Measured: > 14 days after 3 doses vaccination.
Secondary outcomes (9)
Evaluate the safety and reactogenicity
The occurrence of solicited local and systemic adverse events (AEs) within 7 days after each vaccination.
Measured: within 7 days after each vaccination
Evaluate the safety and reactogenicity
The occurrence of unsolicited AEs from the 1st dose to 28 days after the 3rd vaccination
Measured: from the 1st dose to 28 days after the 3rd vaccination.
Evaluate the safety and reactogenicity
The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs) from the 1st dose to the end of study.
Measured: from the 1st dose to the end of study.
To evaluate the efficacy of ReCOV in preventing RT-PCR confirmed symptomatic COVID-19 with various severity in adults
RT-PCR confirmed moderate, severe, critical COVID -19, or death that occurred > 14 days after 3 doses vaccination
Measured: > 14 days after 3 doses vaccination.
To evaluate the efficacy of ReCOV in preventing RT-PCR confirmed symptomatic COVID-19 with various severity in adults
RT-PCR confirmed severe, critical COVID-19, or death that occurred > 14 days after 3 doses vaccination.
Measured: > 14 days after 3 doses vaccination.
To evaluate the efficacy of ReCOV in preventing RT-PCR confirmed symptomatic COVID-19 with various severity in adults
RT-PCR confirmed symptomatic COVID-19 cases (regardless of severity) that occurred > 14 days after 3 doses vaccination in different age groups (18-59 years and ≥ 60 years ).
Measured: > 14 days after 3 doses vaccination in different age groups (18-59 years and ≥ 60 years ).
To evaluate the immunogenicity of ReCOV
The seroconversion rate (SCR), geometric mean titer (GMT) and geometric mean increase (GMI) of neutralizing antibody against prototype and epidemic strain at 14 days, 3 months and 6 months after 3 doses vaccination.
Measured: at 14 days, 3 months and 6 months after 3 doses vaccination
To compare the immunogenicity of ReCOV between Asian and Non-Asian in the immunogenicity subgroup
The SCR and GMT of neutralizing antibody against prototype at 14 days,3 months and 6 months after 3 doses vaccination.
Measured: at 14 days,3 months and 6 months after 3 doses vaccination
Genotyping of SARS-CoV-2 virus nucleic acid sequence of COVID-19 cases to evaluate the possible viral mutations
SARS-CoV-2 virus nucleic acid sequence of RT-PCR confirmed symptomatic COVID-19 cases that occurred >14 days after 3 doses vaccination derived from isolates or direct nasopharyngeal (NP) (preferred)/ oropharyngeal (OP) swab, or respiratory samples (including saliva samples, or bronchoalveolar lavage fluid, if applicable).
Measured: >14 days after 3 doses vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start31 Oct 2022
- Primary completion4 Sep 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7,623 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Rec-Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398848
- Sponsor's protocol ID
- REC611C303
- Status last verified
- Feb 2024
- First submitted
- 30 May 2022
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data (IPD) available
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blinded, Placebo-controlled Phase III Trial to Evaluate the Efficacy, Safety and Immunogenicity of the Recombinant Two-component COVID-19 Vaccine (CHO Cell) in Adults Aged 18 Years and Older
- ClinicalTrials.gov ID
- NCT05398848
- Acronym / sponsor ID
- REC611C303
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,623 participants (actual)
- Lead sponsor
- Jiangsu Rec-Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 4 Sep 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 1 Jun 2022 (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 multicenter designed Phase III clinical trial. About 10000 participants plan to be enrolled.The objectives of this study are to evaluate the efficacy, safety and immunogenicity of the recombinant two-component COVID-19 vaccine (CHO cell) in adults
Detailed description
This study is a multicenter, randomized, double-blinded, placebo-controlled Phase III clinical trial. The objectives are to evaluate the efficacy, safety, and immunogenicity of ReCOV in adults aged 18 years and older who have not received any COVID-19 vaccination, and have no history of known COVID-19 in previous 6 months. Three-dose intramuscular (IM) vaccination schedule (21 days interval) will be applied.
About 10000 participants (about 15% participants ≥ 60 years old) with SARS-CoV-2 antibody (IgM and IgG) negative at baseline, will be randomized in a ratio of 1:1 to receive ReCOV (20 μg) or placebo on Day 0, Day 21, and Day 42, respectively. Participants will be stratified by age (18-59 years, ≥ 60 years) and study sites (if applicable).
For efficacy visits, study staff will contact participants on a weekly basis to remind reporting any signs or symptoms of COVID-19. If participants report any signs or symptoms that may be related to COVID-19, they will be required to immediately conduct an unscheduled visit under the instruction by site staff for COVID-19 related assessment and receiving treatment as deemed appropriate.
For reactogenicity and safety visits, all vaccinated participants will be observed for 30 minutes after each dose vaccination at study site for solicited or unsolicited AEs, and will be given subject diary to record solicited AEs within 7 days after each vaccination, and unsolicited AEs from the 1st vaccination to 28 days after the 3rd vaccination.
Approximately 600 participants will be included in the immunogenicity subgroup. Except for the efficacy and safety follow-up visits described above, this subgroup will be collected blood sample on Day 0 (pre-vaccination) and 14 days (+3 days), 90 days (±15 days) and 6 months (±15 days) after the 3rd dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant two-component COVID-19 vaccine (CHO cell) | Experimental | Biological: Recombinant two-component COVID-19 vaccine (CHO cell)Antigen: NTD-RBD-foldon protein, Adjuvant (BFA03) |
| Placebo | Placebo comparator | Biological: PlaceboAdjuvant (BFA03) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18 years and older.
- Able and willing to comply with all study requirements.
- Willing to allow investigators to discuss the medical history with his/her general practitioner/personal doctors and access all medical records which are relevant to study procedures.
- Healthy adults, or adults with stable medical condition who have a pre-existing medical condition that does not meet any exclusion criteria. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
- For females of childbearing potential only, willing to practice continuous effective contraception until 90 days after the final dose vaccination, and have negative pregnancy tests before each dose vaccination.
Key exclusion criteria (18 listed)
- Laboratory confirmed SARS-CoV-2 infection defined by RT-PCR assay at screening. Participants with negative result for rapid antigen testing can be enrolled before having the result of RT-PCR assay, however, the participant needs to be withdrawn the following vaccination if the RT-PCR result shows positive.
- SARS-CoV-2 antibodies (IgM or IgG) positive at screening.
- Medical history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS) and COVID-19 within 6 months prior to the randomization.
- Fever (oral temperature ≥ 37.5°C / axillary temperature ≥ 37.3°C) on the day of vaccination or within recent 72 hours.
- History of severe allergic disease or reactions likely to be exacerbated by any component of ReCOV, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopaenic purpura, local hypersensitive necrosis reaction (Arthus reaction), or prior history of serious adverse reaction to any vaccine or drug, such as allergy, urticaria eczema, dyspnea, and angioneurotic edema.
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 |
|---|---|---|
| Recombinant two-component COVID-19 vaccine (CHO cell)Before reconstitution: Lyophilized powder for reconstitution in single-use vials After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter | Biological | Recombinant two-component COVID-19 vaccine (CHO cell) |
| PlaceboBefore reconstitution: Lyophilized powder for reconstitution in single-use vials After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter | Biological | Placebo |
Primary outcome
To evaluate the efficacy of ReCOV in preventing Reverse Transcription-Polymerase Chain Reaction (RT-PCR) confirmed symptomatic COVID-19 in adults
Time frame: > 14 days after 3 doses vaccination.
RT-PCR confirmed symptomatic COVID-19 cases (regardless of severity) that occurred > 14 days after 3 doses vaccination.
9 secondary outcomes
Evaluate the safety and reactogenicity
Time frame: within 7 days after each vaccination
Evaluate the safety and reactogenicity
Time frame: from the 1st dose to 28 days after the 3rd vaccination.
Evaluate the safety and reactogenicity
Time frame: from the 1st dose to the end of study.
To evaluate the efficacy of ReCOV in preventing RT-PCR confirmed symptomatic COVID-19 with various severity in adults
Time frame: > 14 days after 3 doses vaccination.
To evaluate the efficacy of ReCOV in preventing RT-PCR confirmed symptomatic COVID-19 with various severity in adults
Time frame: > 14 days after 3 doses vaccination.
To evaluate the efficacy of ReCOV in preventing RT-PCR confirmed symptomatic COVID-19 with various severity in adults
Time frame: > 14 days after 3 doses vaccination in different age groups (18-59 years and ≥ 60 years ).
To evaluate the immunogenicity of ReCOV
Time frame: at 14 days, 3 months and 6 months after 3 doses vaccination
To compare the immunogenicity of ReCOV between Asian and Non-Asian in the immunogenicity subgroup
Time frame: at 14 days,3 months and 6 months after 3 doses vaccination
Genotyping of SARS-CoV-2 virus nucleic acid sequence of COVID-19 cases to evaluate the possible viral mutations
Time frame: >14 days after 3 doses vaccination
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 29 Feb 2024.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data (IPD) available
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant two-component COVID-19 vaccine (CHO cell) in people with COVID-19, run by Jiangsu Rec-Biotechnology Co., Ltd. at 11 sites in 2 countries.
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 10 inclusion and 18 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 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Russia, Nepal. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To evaluate the efficacy of ReCOV in preventing Reverse Transcription-Polymerase Chain Reaction (RT-PCR) confirmed symptomatic COVID-19 in adults (time frame: > 14 days after 3 doses vaccination.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Feb 2024.