COVID-19Phase 2NCT05308602

A Study to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E (Two Recombinant Protein COVID-19 Vaccines) in Population Aged ≥12 Years

A Phase 2 study testing SCTV01C, SCTV01E and mRNA vaccine manufactured by Pfizer or Moderna in people with COVID-19 and SARS-CoV-2 Infection, run by Sinocelltech Ltd..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The objective of the study is to evaluate the immunogenicity and safety of SCTV01C or SCTV01E, comparing the immunogenicity data against Beta (B.1.351), Delta (B.1.617.2), Omicron (B.1.1.529) and other variants with Sinopharm inactivated COVID-19 vaccine or mRNA vaccine. Read more about this study

Who is it for?: Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19, SARS-CoV-2 Infection
What is being tested?: SCTV01C, SCTV01E and mRNA vaccine manufactured by Pfizer or Moderna
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 1 Apr 2022to 1 Aug 2023
Phase: Phase 2
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

Who may be able to join

Male or female aged ≥12 years old when signing ICF;
Participants who were neither vaccinated with any COVID-19 vaccine (including COVID-19 vaccine or vaccine adjuvant in clinical trial) nor diagnosed with COVID-19;
Participants or his/her legal guardian (or entrusted person) can sign written ICF and voluntarily participate in the trial, and can fully understand the trial procedure, the risk of participating in the trial, and other interventions that can be selected if they do not participate in the trial;
Participant him/herself or with the assistance of his/her family member is capable of finishing the record cards;
Healthy participants or participants with pre-existing medical conditions who are in stable condition. The "pre-existing medical conditions" include but not limited to hypertension, diabetes, chronic cholecystitis and cholelithiasis, chronic gastritis that meet the described criteria. A stable medical condition is defined as disease not requiring significant change in therapy or no need for hospitalization as a consequence of worsening disease state for at least 3 months prior to enrollment;
Fertile men and women of childbearing age voluntarily agree to take effective contraceptive measures from signing ICF to 6 months after the last dose of study vaccination; the pregnancy test results of women of childbearing age are negative on screening.

Who cannot join

Presence of fever within 3 days before the study vaccination;
A positive result of IgG antibody against the SARS-CoV-2 virus during the screen period;
A history of infection or disease related to severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), or corresponding immunosuppressants;
A history of allergic reactions to any vaccine or drug, such as allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema;
A medical or family history of seizure, epilepsy, encephalopathy and psychosis;
Immunocompromised patients suffering from immunodeficiency diseases, important organ diseases, immune diseases (including Guillain-Barre Syndrome [GBS], systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy caused by any circumstances, and other immune diseases that may have an impact on immune response in the investigator's opinion), etc.;

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Long-term use of immunosuppressant therapy or immunomodulatory drugs for ≥14 days within the 1st six months prior to enrollment. Whereas short-term (≤14 days) use of oral, inhaled and topical steroids are allowed.
Patients on antituberculosis therapy;
Presence of severe or uncontrollable cardiovascular diseases, or severe or uncontrollable disorders related to endocrine system, blood and lymphatic system, liver and kidney, respiratory system, metabolic and skeletal systems, or malignancies (exception for skin basal cell carcinoma and carcinoma in-situ of cervix) , such as severe heart failure, severe pulmonary heart disease, unstable angina, liver failure, or uremia;
Contraindications for intramuscular injection or intravenous blood sampling, including thrombocytopenia and other blood coagulation disorders;
Participants who received any immunoglobulin or blood products in the previous 3 months, or plan to receive similar products during the study;
Participants who received other investigational drugs within 1 month before the study vaccination;
Participants who is at the acute state of disease, such as acute onset of chronic heart failure, acute sore throat, hypertensive encephalopathy, acute pneumonia, acute renal insufficiency, acute cholecystitis;
Participants received other drugs used for prevention of COVID-19;
Participants vaccinated with influenza vaccine within 14 days or with other vaccines within 28 days before the study vaccination;
Those who donated blood or had blood loss (≥450 mL) within 3 months before the vaccination or plan to donate blood during the study period;
Those who are pregnant or breast-feeding or plan to be pregnant during the study period;
Those who plan to donate ovum or sperms during the study period;
Those who cannot follow the trial procedures, or cannot cooperate to complete the study due to planned relocation or long-term outing;
Those unsuitable for participating in the clinical trial as determined by the investigator because of other abnormalities that are likely to confuse the study results, or non-conformance with the maximal benefits of the participants;
Those who are tested positive for HIV in terms of serology.

About this study

Official title: A Randomized, Double-blinded, Active-controlled Phase II Clinical Study to Evaluate the Immunogenicity and Safety of SCTV01C (A Bivalent SARS-CoV-2 Trimeric Spike Protein Vaccine) and SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in Population Aged ≥12 Years and Previously Unvaccinated

Read the detailed description

The study is a randomized, double-blinded, active-controlled (Approved vaccine) Phase II clinical study. The study consists of 2 stages, Stage 1 and 2. In Stage 1, participants would randomly receive 2 doses of SCTV01C, SCTV01E, Sinopharm COVID-19 vaccine or mRNA vaccine on Day 0 and Day 28. Stage 1 is aimed to evaluate the immunogenicity and safety of SCTV01C or SCTV01E, comparing the immunogenicity data against Beta (B.1.351), Delta (B.1.617.2), Omicron (B.1.1.529) and other variants after the 2nd dose of vaccination with Sinopharm inactivated COVID-19 vaccine or mRNA vaccine. Stage 2 will start on Day 180 and the participants will receive a 3rd dose of vaccination.

Conditions: COVID-19, SARS-CoV-2 Infection
Being tested: SCTV01C, SCTV01E, mRNA vaccine manufactured by Pfizer or Moderna, Sinopharm inactivated COVID-19 vaccine
Keywords: COVID-19, SARS-CoV-2 infection, Vaccine
Medical subject headings: COVID-19

What participants receive

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

SCTV01CBiological
Day 0; intramuscular injection
SCTV01CBiological
Day 28; intramuscular injection
SCTV01CBiological
Day 180; intramuscular injection
SCTV01EBiological
Day 0; intramuscular injection
SCTV01EBiological
Day 28; intramuscular injection
SCTV01EBiological
Day 180; intramuscular injection
mRNA vaccine manufactured by Pfizer or ModernaBiological
Day 0; intramuscular injection
mRNA vaccine manufactured by Pfizer or ModernaBiological
Day 28; intramuscular injection
mRNA vaccine manufactured by Pfizer or ModernaBiological
Day 180; intramuscular injection
Sinopharm inactivated COVID-19 vaccineBiological
Day 0; intramuscular injection
Sinopharm inactivated COVID-19 vaccineBiological
Day 28; intramuscular injection
Sinopharm inactivated COVID-19 vaccineBiological
Day 180; intramuscular injection

Study groups in NCT05308602
Study group	Role	What they receive
SCTV01C	Experimental	Not described Receives: Biological: SCTV01C
SCTV01E	Experimental	Not described Receives: Biological: SCTV01E
mRNA vaccine manufactured by Pfizer or Moderna	Active comparator	Not described Receives: Biological: mRNA vaccine manufactured by Pfizer or Moderna
Sinopharm inactivated COVID-19 vaccine	Active comparator	Not described Receives: Biological: Sinopharm inactivated COVID-19 vaccine

What is being measured

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

Stage 1: Geometric mean titers (GMT) of neutralizing antibody against Beta (B.1.351) variant on Day 56 (28 days after the 2nd dose of vaccination);
Measured: Day 56 after the study vaccination
Stage 1: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 56 (28 days after the 2nd dose of vaccination);
Measured: Day 56 after the study vaccination
Stage 1: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 56 (28 days after the 2nd dose of vaccination);
Measured: Day 56 after the study vaccination
Stage 2: GMT of neutralizing antibody against Beta (B.1.351) variant on Day 208 (28 days after the 3rd dose of vaccination);
Measured: Day 208 after the study vaccination
Stage 2: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 208 (28 days after the 3rd dose of vaccination);
Measured: Day 208 after the study vaccination
Stage 2: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 208 (28 days after the 3rd dose of vaccination);
Measured: Day 208 after the study vaccination
Incidence and severity of solicited AEs within 7 days after each dose of vaccine (Day 0 to Day 7, Day 28 to Day 35, and Day 180 to Day 187).
Measured: 7 days after each study vaccination

Secondary outcomes (12)

Stage 1: GMT of neutralizing antibody against Beta (B.1.351) variant on Day 180 (before the injection of the 3rd dose of vaccination);
Measured: Day 180 after the study vaccination
Stage 1: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 180 (before the injection of the 3rd dose of vaccination);
Measured: Day 180 after the study vaccination
Stage 1: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 180 (before the injection of the 3rd dose of vaccination);
Measured: Day 180 after the study vaccination
Stage 1: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subpopulations on Day 0, Day14, Day 28 and Day 42;
Measured: Day 0, Day 14, Day 28 and Day 42 after the study vaccination
Stage 1: Seroresponse rates of neutralizing antibodies to Beta [B.1.351], Delta [B.1.617.2] and Omicron [B.1.1.529] variants on Day 56;
Measured: Day 56 after the study vaccination
Stage 2: GMT of neutralizing antibody against Beta (B.1.351) variant on Day 365 (185 days after the 3rd dose of vaccination);
Measured: Day 365 after the study vaccination
Stage 2: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 365 (185 days after the 3rd dose of vaccination);
Measured: Day 365 after the study vaccination
Stage 2: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 365 (185 days after the 3rd dose of vaccination);
Measured: Day 365 after the study vaccination
Stage 2: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subpopulations on Day 180 (Before the injection of the 3rd dose of vaccination) and Day 194 (14 days after the 3rd dose of vaccination);
Measured: Day 180 (Before the injection of the 3rd dose of vaccination) and Day 194 (14 days after the 3rd dose of vaccination)
Stage 2: Seroresponse rates of neutralizing antibodies to Beta [B.1.351], Delta [B.1.617.2] and Omicron [B.1.1.529] variants on Day 208;
Measured: Day 208 after the study vaccination
Incidence and severity of unsolicited systemic AEs within 28 days after each dose of vaccine (Day 0 to Day 28, Day 28 to Day 56, and Day 180 to Day 208);
Measured: 28 days after each study vaccination
Incidence and severity of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 365 days after the 1st dose of vaccination.
Measured: Day 0 to Day 365 after the study vaccination

Timeline

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

1 Apr 20221 Aug 2023

First posted4 Apr 2022
Study start1 Apr 2022 (estimated)
Primary completion1 Aug 2022 (estimated)
Study completion1 Aug 2023 (estimated)

Why it stopped: There was not a need any more.

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.
More trials run by Sinocelltech Ltd.The 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05308602
Sponsor's protocol ID: SCTV01C/E-02-In-Laos-1
Status last verified: Mar 2022
First submitted: 15 Feb 2022
Last updated: 9 Feb 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blinded, Active-controlled Phase II Clinical Study to Evaluate the Immunogenicity and Safety of SCTV01C (A Bivalent SARS-CoV-2 Trimeric Spike Protein Vaccine) and SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in Population Aged ≥12 Years and Previously Unvaccinated
ClinicalTrials.gov ID: NCT05308602
Acronym / sponsor ID: SCTV01C/E-02-In-Laos-1
Conditions: COVID-19, SARS-CoV-2 Infection
Keywords: COVID-19, SARS-CoV-2 infection, Vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: There was not a need any more.
Enrolment: 0 participants (actual)
Lead sponsor: Sinocelltech Ltd.Industry (pharma, biotech, devices)
Study start: 1 Apr 2022 (estimated)
Primary completion: 1 Aug 2022 (estimated)
Study completion: 1 Aug 2023 (estimated)
First posted: 4 Apr 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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
SCTV01C	Experimental	Biological: SCTV01C
SCTV01E	Experimental	Biological: SCTV01E
mRNA vaccine manufactured by Pfizer or Moderna	Active comparator	Biological: mRNA vaccine manufactured by Pfizer or Moderna
Sinopharm inactivated COVID-19 vaccine	Active comparator	Biological: Sinopharm inactivated COVID-19 vaccine

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Male or female aged ≥12 years old when signing ICF;
Participants who were neither vaccinated with any COVID-19 vaccine (including COVID-19 vaccine or vaccine adjuvant in clinical trial) nor diagnosed with COVID-19;
Participants or his/her legal guardian (or entrusted person) can sign written ICF and voluntarily participate in the trial, and can fully understand the trial procedure, the risk of participating in the trial, and other interventions that can be selected if they do not participate in the trial;
Participant him/herself or with the assistance of his/her family member is capable of finishing the record cards;
Healthy participants or participants with pre-existing medical conditions who are in stable condition. The "pre-existing medical conditions" include but not limited to hypertension, diabetes, chronic cholecystitis and cholelithiasis, chronic gastritis that meet the described criteria. A stable medical condition is defined as disease not requiring significant change in therapy or no need for hospitalization as a consequence of worsening disease state for at least 3 months prior to enrollment;

Key exclusion criteria (21 listed)

Presence of fever within 3 days before the study vaccination;
A positive result of IgG antibody against the SARS-CoV-2 virus during the screen period;
A history of infection or disease related to severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), or corresponding immunosuppressants;
A history of allergic reactions to any vaccine or drug, such as allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema;
A medical or family history of seizure, epilepsy, encephalopathy and psychosis;

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
SCTV01CDay 0; intramuscular injection	Biological	SCTV01C
SCTV01CDay 28; intramuscular injection	Biological	SCTV01C
SCTV01CDay 180; intramuscular injection	Biological	SCTV01C
SCTV01EDay 0; intramuscular injection	Biological	SCTV01E
SCTV01EDay 28; intramuscular injection	Biological	SCTV01E
SCTV01EDay 180; intramuscular injection	Biological	SCTV01E
mRNA vaccine manufactured by Pfizer or ModernaDay 0; intramuscular injection	Biological	mRNA vaccine manufactured by Pfizer or Moderna
mRNA vaccine manufactured by Pfizer or ModernaDay 28; intramuscular injection	Biological	mRNA vaccine manufactured by Pfizer or Moderna
mRNA vaccine manufactured by Pfizer or ModernaDay 180; intramuscular injection	Biological	mRNA vaccine manufactured by Pfizer or Moderna
Sinopharm inactivated COVID-19 vaccineDay 0; intramuscular injection	Biological	Sinopharm inactivated COVID-19 vaccine
Sinopharm inactivated COVID-19 vaccineDay 28; intramuscular injection	Biological	Sinopharm inactivated COVID-19 vaccine
Sinopharm inactivated COVID-19 vaccineDay 180; intramuscular injection	Biological	Sinopharm inactivated COVID-19 vaccine

Primary outcome

Stage 1: Geometric mean titers (GMT) of neutralizing antibody against Beta (B.1.351) variant on Day 56 (28 days after the 2nd dose of vaccination);
Time frame: Day 56 after the study vaccination
Stage 1: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 56 (28 days after the 2nd dose of vaccination);
Time frame: Day 56 after the study vaccination
Stage 1: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 56 (28 days after the 2nd dose of vaccination);
Time frame: Day 56 after the study vaccination
Stage 2: GMT of neutralizing antibody against Beta (B.1.351) variant on Day 208 (28 days after the 3rd dose of vaccination);
Time frame: Day 208 after the study vaccination
Stage 2: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 208 (28 days after the 3rd dose of vaccination);
Time frame: Day 208 after the study vaccination
Stage 2: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 208 (28 days after the 3rd dose of vaccination);
Time frame: Day 208 after the study vaccination
Incidence and severity of solicited AEs within 7 days after each dose of vaccine (Day 0 to Day 7, Day 28 to Day 35, and Day 180 to Day 187).
Time frame: 7 days after each study vaccination

12 secondary outcomes

Stage 1: GMT of neutralizing antibody against Beta (B.1.351) variant on Day 180 (before the injection of the 3rd dose of vaccination);
Time frame: Day 180 after the study vaccination
Stage 1: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 180 (before the injection of the 3rd dose of vaccination);
Time frame: Day 180 after the study vaccination
Stage 1: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 180 (before the injection of the 3rd dose of vaccination);
Time frame: Day 180 after the study vaccination
Stage 1: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subpopulations on Day 0, Day14, Day 28 and Day 42;
Time frame: Day 0, Day 14, Day 28 and Day 42 after the study vaccination
Stage 1: Seroresponse rates of neutralizing antibodies to Beta [B.1.351], Delta [B.1.617.2] and Omicron [B.1.1.529] variants on Day 56;
Time frame: Day 56 after the study vaccination
Stage 2: GMT of neutralizing antibody against Beta (B.1.351) variant on Day 365 (185 days after the 3rd dose of vaccination);
Time frame: Day 365 after the study vaccination
Stage 2: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 365 (185 days after the 3rd dose of vaccination);
Time frame: Day 365 after the study vaccination
Stage 2: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 365 (185 days after the 3rd dose of vaccination);
Time frame: Day 365 after the study vaccination
Stage 2: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subpopulations on Day 180 (Before the injection of the 3rd dose of vaccination) and Day 194 (14 days after the 3rd dose of vaccination);
Time frame: Day 180 (Before the injection of the 3rd dose of vaccination) and Day 194 (14 days after the 3rd dose of vaccination)
Stage 2: Seroresponse rates of neutralizing antibodies to Beta [B.1.351], Delta [B.1.617.2] and Omicron [B.1.1.529] variants on Day 208;
Time frame: Day 208 after the study vaccination
Incidence and severity of unsolicited systemic AEs within 28 days after each dose of vaccine (Day 0 to Day 28, Day 28 to Day 56, and Day 180 to Day 208);
Time frame: 28 days after each study vaccination
Incidence and severity of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 365 days after the 1st dose of vaccination.
Time frame: Day 0 to Day 365 after the study vaccination

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.

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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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SCTV01C, SCTV01E and mRNA vaccine manufactured by Pfizer or Moderna in people with COVID-19 and SARS-CoV-2 Infection, run by Sinocelltech Ltd..

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 6 inclusion and 21 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: withdrawn, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Stage 1: Geometric mean titers (GMT) of neutralizing antibody against Beta (B.1.351) variant on Day 56 (28 days after the 2nd dose of vaccination); (time frame: Day 56 after the study vaccination). The study lists 7 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 NCT05308602.

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 9 Feb 2024.