COVID-19Phase 1/2NCT04470609
Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19 in People Aged ⩾60 Years
A Phase 1/2 study testing Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule, Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule and High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule in people with COVID-19, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study is a randomized, double-blinded, and placebo-controlled phase Ib/IIb clinical trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the vaccine in healthy people aged ⩾60 Years. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule, Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule and High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 471 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2020to 27 Oct 2021
- Phase
- Phase 1/2
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Phase Ib:
- Healthy people aged ⩾60 years (including boundary values), both men and women.
- Proven legal identity.
- Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
- Participants should be able to communicate well with investigators, understand and comply with the requirements of this trial.
- Axillary temperature ≤37.0 ℃.
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- Phase IIb:
- Healthy people aged ⩾60 years (including boundary values), both men and women.
- Proven legal identity.
- Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
- Participants should be able to communicate well with investigators, understand and comply with the requirements of this trial.
- Axillary temperature ≤37.0 ℃.
Who cannot join
- Phase Ib:
- Contraindications for vaccination.
- History of allergy to vaccines or drugs.
- Immunization with any vaccine within 1 month.
- Diseases that cannot be controlled by drugs, such as hypertension, diabetes, asthma, etc.
- Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
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- Those who have a hereditary bleeding tendency or coagulation dysfunction, or a history of thrombosis or bleeding disorders.
- Those who cannot tolerate venipuncture, or have a history of halo needles or halo blood.
- For any reason, the spleen was removed partially or completely.
- Those who have undergone surgery within 3 months before signing the informed consent, or those who plan to perform surgery during the trial or within 3 months after the end of the trial (including cosmetic surgery, dental and oral surgery).
- Those who donated or lost blood (≥200 mL) in the past 3 months, who received blood transfusion or use of blood products, or who planned blood donation during the trial.
- Receipt of other investigational or unregistered products (drugs, vaccines, biological product or devices) in the past 3 months, or plan to use other investigational or unregistered products during the study.
- Receipt of immunosuppressive therapy within 6 months before signing the informed consent form, such as long-term systemic glucocorticoid therapy (with systemic glucocorticoid therapy for more than 2 weeks within 6 months, such as prednisone or similar drugs) ), but local administration (such as ointment, eye drops, inhalation, or nasal spray) is allowed. The local administration should not exceed the dosage recommended in the instructions or have any signs of systemic exposure.
- Those who have took soft drugs (such as marijuana) within 3 months before signing the informed consent form or took hard drugs (such as: cocaine, phencyclidine, etc.) within 1 year before the trial.
- Those who smoked more than 5 cigarettes per day within 3 months before signing the informed consent form.
- The weekly drinking volume is greater than 14 units within 3 months before signing the informed consent form (1 unit alcohol approximately equal to 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine).
- The comprehensive physical examination does not meet the health standards, mainly including: (1) Those with abnormal vital signs with clinical significance. (2) BMI<18 kg/m^2 or> 30 kg/m^2. (3) Abnormal laboratory examination with clinical significance. (4) Those who tested positive for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis B e antigen, hepatitis C virus antibody, or Treponema pallidum antibody (tp-trust).
- Women who have a positive pregnancy test, or men who have a birth plan or plan to donate sperm from the screening to 12 months after the second vaccination.
- Positive in drug abuse screening during the screening period (Morphine, Methamphetamine, Ketamine, MDMA and Tetrahydrocannabinolic acid).
- Positive in alcohol breath test during the screening period.
- Positive in SARS-CoV-2 nucleic acid screening or antibodies (IgG or IgM) screening.
- History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS) or other coronavirus infection (HCoV-229E, HCoV-OC43, HCoV-NL63, HCoV-HKU1).
- History of contact with confirmed or suspected cases infected with SARS-CoV-2 within 1 month.
- Any other situations judged by investigators as not suitable for participating in this study.
- Phase IIb:
- Contraindications for vaccination.
- History of allergy to vaccines or drugs.
- Immunization with any vaccine within 1 month.
- Diseases that cannot be controlled by drugs, such as hypertension, diabetes, asthma, etc.
- Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
- Those who have a hereditary bleeding tendency or coagulation dysfunction, or a history of thrombosis or bleeding disorders.
- For any reason, the spleen was removed partially or completely.
- Those who have undergone surgery within 3 months before signing the informed consent, or those who plan to perform surgery during the trial or within 3 months after the end of the trial (including cosmetic surgery, dental and oral surgery).
- Those who donated or lost blood (≥200 mL) in the past 3 months, who received blood transfusion or use of blood products, or who planned blood donation during the trial.
- Receipt of other investigational or unregistered products (drugs, vaccines, biological product or devices) in the past 3 months, or plan to use other investigational or unregistered products during the study.
- Receipt of immunosuppressive therapy within 6 months before signing the informed consent form, such as long-term systemic glucocorticoid therapy (with systemic glucocorticoid therapy for more than 2 weeks within 6 months, such as prednisone or similar drugs) ), but local administration (such as ointment, eye drops, inhalation, or nasal spray) is allowed. The local administration should not exceed the dosage recommended in the instructions or have any signs of systemic exposure.
- Women who have a positive pregnancy test, or men who have a birth plan or plan to donate sperm from the screening to 12 months after the second vaccination.
- History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS) or other coronavirus infection (HCoV-229E, HCoV-OC43, HCoV-NL63, HCoV-HKU1).
- History of contact with confirmed or suspected cases infected with SARS-CoV-2 within 1 month.
- The comprehensive physical examination does not meet the health standards, mainly including: (1) Those with abnormal vital signs (Pulse <55 beats per minute or> 100 beats per minute at rest, Systolic blood pressure ≥140mmHg or Diastolic blood pressure ≥90mmHg, breathing> 20 beats per minute or <12 beats per minute). (2) Those who tested positive for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis B e antigen, hepatitis C virus antibody, or Treponema pallidum antibody (tp-trust).
- Positive in SARS-CoV-2 nucleic acid screening or antibodies (IgG or IgM) screening.
- Any other situations judged by investigators as not suitable for participating in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
West China Second University Hospital, Sichuan University / West China women's and children's Hospital
Chengdu, Sichuan, 610041
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase Ib/IIb Trial of an Inactivated SARS-CoV-2 Vaccine in Healthy People Aged ⩾60 Years
This study is a randomized, double-blinded, and placebo-controlled phase Ib/IIb clinical trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the vaccine in healthy people aged ⩾60 Years.
Read the detailed description
This phase Ib/IIb trial is designed to evaluate the safety and immunogenicity of different doses of the Inactivated SARS-CoV-2 Vaccine based upon the randomized, double-blind and placebo-controlled principle. A total of 471 subjects aged ⩾60 years will be enrolled in the study, of which 96 and 375 will be enrolled for phase Ib and phase Ⅱb,respectively. The enrolled subjects in phase Ib receive two doses of low-, medium-, or high-dose of experimental vaccines or placebo at an interval of 28 days, while the enrolled subjects in Phase Ⅱb receive two doses of medium, high-dose experimental vaccines or placebo at an interval of 28 days.
- Conditions
- COVID-19
- Being tested
- Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule, Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule, High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule, Placebo on a 0- and 28-day schedule
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day scheduleBiological
Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day scheduleBiological
Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day scheduleBiological
Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
Placebo on a 0- and 28-day scheduleBiological
Two doses of placebo at the vaccination schedule of day 0,28
| Study group | Role | What they receive |
|---|---|---|
| Low dosage vaccine on a 0- and 28-day schedule | Experimental | Two doses of low dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28 Receives: Biological: Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule |
| Medium dosage vaccine on a 0- and 28-day schedule | Experimental | Two doses of medium dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28 Receives: Biological: Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule |
| High dosage vaccine on a 0- and 28-day schedule | Experimental | Two doses of high dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28 Receives: Biological: High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule |
| Placebo on a 0- and 28-day schedule | Placebo comparator | Two doses of placebo at the vaccination schedule of day 0, 28 Receives: Biological: Placebo on a 0- and 28-day schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse reactions/events rate
Occurence of adverse reactions/events after vaccination
Measured: 7 days after vaccination
Adverse reactions/events rate
Occurence of adverse reactions/events after vaccination
Measured: 28 days after vaccination
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIb
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for Phase IIb with vaccination schedule of day 0, 28
Measured: 28 days after vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIb
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase IIb with vaccination schedule of day 0, 28
Measured: 28 days after vaccination
Secondary outcomes (7)
Serious adverse events
Occurence of Serious adverse events after vaccination
Measured: 12 months after the second vaccination
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ib
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for Phase Ib with vaccination schedule of day 0, 28
Measured: 28 days after the second vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ib
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase Ib with vaccination schedule of day 0, 28
Measured: 28 days after the second vaccination
Level of Neutralizing antibodies against SARS-CoV-2 Phase Ib
Level of neutralizing antibodies against SARS-CoV-2 in serum for Phase Ib with vaccination schedule of day 0, 28
Measured: 7 and 28 days after the second vaccination
Level of IgG antibodies against SARS-CoV-2 Phase Ib
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase Ib with vaccination schedule of day 0, 28
Measured: 7 and 28 days after the second vaccination
Level of Neutralizing antibodies against SARS-CoV-2 Phase IIb
Level of neutralizing antibodies against SARS-CoV-2 in serum for Phase IIb with vaccination schedule of day 0, 28
Measured: 28 days after the second vaccination
Level of IgG antibodies against SARS-CoV-2 Phase IIb
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase IIb with vaccination schedule of day 0, 28
Measured: 28 days 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 posted14 Jul 2020
- Study start10 Jul 2020
- Primary completion30 Oct 2020
- Study completion27 Oct 2021
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- West China Second University Hospital, Yunnan Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Qin Yu, Principal investigator, West China Second University HospitalXiaoqiang Liu, Principal investigator, Yunnan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470609
- Sponsor's protocol ID
- 20200402
- Status last verified
- Oct 2023
- First submitted
- 13 Jul 2020
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase Ib/IIb Trial of an Inactivated SARS-CoV-2 Vaccine in Healthy People Aged ⩾60 Years
- ClinicalTrials.gov ID
- NCT04470609
- Acronym / sponsor ID
- 20200402
- Conditions
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- West China Second University Hospital, Yunnan Center for Disease Control and Prevention
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 14 Jul 2020 (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 study is a randomized, double-blinded, and placebo-controlled phase Ib/IIb clinical trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the vaccine in healthy people aged ⩾60 Years.
Detailed description
This phase Ib/IIb trial is designed to evaluate the safety and immunogenicity of different doses of the Inactivated SARS-CoV-2 Vaccine based upon the randomized, double-blind and placebo-controlled principle. A total of 471 subjects aged ⩾60 years will be enrolled in the study, of which 96 and 375 will be enrolled for phase Ib and phase Ⅱb,respectively. The enrolled subjects in phase Ib receive two doses of low-, medium-, or high-dose of experimental vaccines or placebo at an interval of 28 days, while the enrolled subjects in Phase Ⅱb receive two doses of medium, high-dose experimental vaccines or placebo at an interval of 28 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dosage vaccine on a 0- and 28-day schedule | Experimental | Biological: Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day scheduleTwo doses of low dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28 |
| Medium dosage vaccine on a 0- and 28-day schedule | Experimental | Biological: Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day scheduleTwo doses of medium dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28 |
| High dosage vaccine on a 0- and 28-day schedule | Experimental | Biological: High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day scheduleTwo doses of high dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28 |
| Placebo on a 0- and 28-day schedule | Placebo comparator | Biological: Placebo on a 0- and 28-day scheduleTwo doses of placebo at the vaccination schedule of day 0, 28 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Phase Ib:
- Phase IIb:
Key exclusion criteria (42 listed)
- Phase Ib:
- Phase IIb:
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 |
|---|---|---|
| Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day scheduleTwo doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28 | Biological | Low dosage vaccine on a 0- and 28-day schedule |
| Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day scheduleTwo doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28 | Biological | Medium dosage vaccine on a 0- and 28-day schedule |
| High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day scheduleTwo doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28 | Biological | High dosage vaccine on a 0- and 28-day schedule |
| Placebo on a 0- and 28-day scheduleTwo doses of placebo at the vaccination schedule of day 0,28 | Biological | Placebo on a 0- and 28-day schedule |
Primary outcome
Adverse reactions/events rate
Time frame: 7 days after vaccination
Occurence of adverse reactions/events after vaccination
Adverse reactions/events rate
Time frame: 28 days after vaccination
Occurence of adverse reactions/events after vaccination
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIb
Time frame: 28 days after vaccination
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for Phase IIb with vaccination schedule of day 0, 28
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIb
Time frame: 28 days after vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase IIb with vaccination schedule of day 0, 28
7 secondary outcomes
Serious adverse events
Time frame: 12 months after the second vaccination
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ib
Time frame: 28 days after the second vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ib
Time frame: 28 days after the second vaccination
Level of Neutralizing antibodies against SARS-CoV-2 Phase Ib
Time frame: 7 and 28 days after the second vaccination
Level of IgG antibodies against SARS-CoV-2 Phase Ib
Time frame: 7 and 28 days after the second vaccination
Level of Neutralizing antibodies against SARS-CoV-2 Phase IIb
Time frame: 28 days after the second vaccination
Level of IgG antibodies against SARS-CoV-2 Phase IIb
Time frame: 28 days after the second 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 11 Oct 2023.
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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.
Qin Yu principal investigator
West China Second University Hospital
Xiaoqiang Liu principal investigator
Yunnan Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule, Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule and High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule in people with COVID-19, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site 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 12 inclusion and 42 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 11 Oct 2023. 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 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Adverse reactions/events rate (time frame: 7 days after vaccination). The study lists 4 primary outcomes in all. 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 11 Oct 2023.