COVID-19Phase 3COVIDAXISNCT04328285
Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers
A Phase 3 study testing Hydroxychloroquine and Lopinavir and ritonavir in people with COVID-19, run by Centre Hospitalier Universitaire de Saint Etienne at 9 sites in France.
Trial summary
Since December 2019, the emergence of a new coronavirus named SARS-Cov-2 in the city of Wuhan in China has been responsible for a major epidemic of respiratory infections, including severe pneumonia. Within weeks, COVID-19 became a pandemic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Hydroxychloroquine and Lopinavir and ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 9 sitesFrance
- Study dates
- 14 Apr 2020to 30 Mar 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult healthcare workers (HCWs) (for instance physicians, nurses, assistant nurses, dentists, physiotherapists, midwives, etc.)
- HCW involved at the time of enrolment in the care and the management of patients with confirmed or suspected SARS-CoV-2 infection in hospital settings, in outpatient care settings or in geriatric long-term care facilities. These HCWs have prolonged or repeated close contact to these patients.
- HCW tested negative for HIV
- HCW affiliated to the French health insurance system
- HCW women of childbearing age with an effective contraception (ethinylestradiol-containing contraceptive pills are not regarded as effective in the context of LPV/r treatment - COVIDAXIS 2)
- Willing to comply to study design and the follow-up
- Consent form signed
Who cannot join
- For COVIDAXIS 1:
- HCW with positive SARS-CoV-2 RT-PCR of nasopharyngeal swab at the inclusion visit.
- HCW with past history of confirmed SARS-CoV-2 infection
- HCW with positive SARS-CoV-2 serology at the inclusion visit
- HCW with comorbidities such as hypothyroidism that need hormonal substitution, or retinopathy or with prior intermittent porphyria, or chronic renal failure (glomerular filtration rate < 30mL/min) or prior hepatic failure or psoriasis.
- HCW with prior diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency
Show all 23Show fewer
- HCW with known hypersensitivity/allergy to HCQ
- HCW with baseline QTc interval > 450ms in men or > 460ms in women and QTc <320 ms (both gender)
- HCW with personal or family history of long QT syndrome, torsades de pointes, or sudden death
- Pregnant HCW
- Breastfeeding HCW
- HCW taking comedications known to have interactions with HCQ according to the official characteristics of the product
- For COVIDAXIS 2:
- HCW with positive SARS-CoV-2 RT-PCR of nasopharyngeal swab at the inclusion visit.
- HCW with past history of confirmed SARS-CoV-2 infection
- HCW with positive SARS-CoV-2 serology at the inclusion visit
- HCW with comorbidities such as chronic HCV infection treated by direct antiviral drugs or with hypothyroidism that need hormonal substitution, or known to have hypercholesterolemia hypertriglyceridemiaor chronic renal failure (glomerular filtration rate < 30mL/min) or prior hepatic failure
- HCW with known hypersensitivity/allergy to LPV/r
- HCW with baseline QTc interval > 450ms in men or > 460ms in women and QTc <320 ms (both gender)
- HCW with personal or family history of long QT syndrome, torsades de pointes, or sudden death
- Pregnant HCW
- Breastfeeding HCW
- HCW taking comedications known to have interactions with LPV/r according to the official characteristics of the product
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHU d'Angers
Angers
CHU de Bordeaux
Bordeaux, 33000
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
CHU de Montpellier
Montpellier, 34000
CHU de Nancy
Nancy, 54000
CHU de Nantes
Nantes, 44000
CHU de Rennes
Rennes, 35000
CHU de Rouen
Rouen, 76000
CHU de Saint-Etienne
Saint-Etienne
About this study
Official title: Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers : A Randomized Double-blind Placebo-controlled Clinical Trial
Since December 2019, the emergence of a new coronavirus named SARS-Cov-2 in the city of Wuhan in China has been responsible for a major epidemic of respiratory infections, including severe pneumonia. Within weeks, COVID-19 became a pandemic.
In the absence of specific antiviral treatment, a special attention should be given to prevention. Personal protection equipments may be insufficiently protective, including in healthcare workers, a significant proportion of whom (around 4%) having been infected in the outbreaks described in China and more recently in Italy. Infection in healthcare workers could result from the contact with COVID-19 people in community or with infected colleagues or patients.
Read more
As it will take at least a year before vaccines against SARS-CoV-2 becomes available, chemoprophylaxis is an option that should be considered in this setting where prevention of SARS-CoV-2 infection in Health Care Workers.
The COVIDAXIS trial evaluates a chemoprophylaxis of SARS-CoV-2 infection in Health Care Workers. This trial is divided into two distinct studies that could start independently each with its own randomization process: COVIDAXIS 1 will study Hydroxychloroquine (HCQ) versus placebo; COVIDAXIS 2 will study Lopinavir/ritonavir (LPV/r) versus placebo.
Upon randomization healthcare workers (HCWs) involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:
Read the detailed description
The study COVIDAXIS 1(Hydroxychloroquine (HCQ) versus placebo) will be realized on 600 participants and will be implemented first in as many centers as possible.
Upon randomization, with 1:1 allocation ratio, healthcare workers involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:
- Group 1.1: HCQ 200 mg : 2 tablets on the evening at Day 1 and 2 tablets on the morning at Day 2 and 1 tablet once daily afterwards
- Group 1.2: Placebo of HCQ, 2 tablets on the evening at Day 1 and 2 tablets on the morning at Day 2 and 1 tablet once daily afterwards.
The COVIDAXIS 2 (Lopinavir/ritonavir (LPV/r) versus placebo will be realized on 600 participants and will be implemented in already participating and newer centers in a second step (when LPV/r becomes available).
Upon randomization, with 1:1 allocation ratio, healthcare workers involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:
- Group 2.1: LPV/r 200/50 mg : 2 tablets twice daily
- Group 2.2: Placebo of LPV/r, 2 tablets twice daily
Participants will receive the randomized treatment for 2 months and will be followed upon a 2.5 months period.
NB: there is no randomization procedure for participant inclusion in either COVIDAXIS 1 or COVIDAXIS 2
- Conditions
- COVID-19
- Being tested
- Hydroxychloroquine, Placebo of Hydroxychloroquine, Lopinavir and ritonavir, Placebo of LPV/r Tablets
- Keywords
- SARS-CoV-2, COVID-19, nasopharyngeal swab, pneumonia, Hydroxychloroquine, Lopinavir/ritonavir, Healthcare Workers
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Plaquenil
Hydroxychloroquine Oral Tablets
Placebo of HydroxychloroquineDrug
Placebo of Hydroxychloroquine Oral Tablets Placebo manufactured to mimic Hydroxychloroquine tablets
Lopinavir and ritonavirDrug
Also called Kaletra
LPV/r Oral Tablets
Placebo of LPV/r TabletsDrug
Placebo of LPV/r Oral Tablets Placebo manufactured to mimic LPV/r tablets
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine (HCQ) vs Placebo | Experimental | Group 1.1: HCQ 200 mg : 2 tablets on the evening at Day 1 and 2 tablets on the morning at Day 2 and 1 tablet once daily afterwards
Group 1.2: Placebo of HCQ, 2 tablets on the evening at Day 1 and 2 tablets on the morning at Day 2 and 1 tablet once daily afterwards. Receives: Drug: Hydroxychloroquine; Drug: Placebo of Hydroxychloroquine |
| Lopinavir/ritonavir (LPV/r) vs Placebo | Experimental | Group 2.1: LPV/r 200/50 mg, 2 tablets twice daily
Group 2.2: Placebo of LPV/r, 2 tablets twice daily Receives: Drug: Lopinavir and ritonavir; Drug: Placebo of LPV/r Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of an symptomatic or asymptomatic SARS-CoV-2 infection among healthcare workers (HCWs)
An infection by SARS-CoV-2 is defined by either:
- a positive specific Reverse Transcription - Polymerase Chain Reaction (RT-PCR) on periodic systematic nasopharyngeal swab during follow-up OR
- a positive specific RT-PCR on a respiratory sample in case of onset of symptoms consistent with COVID-19 during follow-up OR
- a seroconversion to SARS-CoV-2 after randomization.
Measured: Up to 2.5 months
Secondary outcomes (7)
Evaluation of the occurrence of adverse events in each arm,
Number of adverse events expected or unexpected, related and unrelated to the treatment, notably grades 2, 3 and 4 (moderate, severe and lifethreatening, according to the Adverse National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0) in each arm.
Measured: Up to 2.5 months
Evaluation of the discontinuation rates of the investigational drug in each arm,
Number of treatment discontinuations in each arm
Measured: Up to 2 months
Evaluation of the adherence of participants to study drug,
Treatment adherence rate will be assessed by:
- measurement of LPV and HCQ plasma concentrations using LC-MS/MS or LC-Fluorimetric detection
- the count of returned drugs at each visit.
Measured: Up to 2 months
Evaluation of the incidence of symptomatic cases of SARS-CoV-2 infection in each arm,
Number of incident cases of symptomatic SARS-CoV-2 infections among HCWs in each arm.
Symptomatic infection is defined as :
- a positive specific RT-PCR on a respiratory or non respiratory sample OR
- a thoracic CT scan with imaging abnormalities consistent with COVID-19.
These investigations being performed in case of signs/symptoms consistent with COVID-19 during follow-up.
Measured: Up to 2.5 months
Evaluation of the incidence of asymptomatic cases of SARS-CoV-2 infection in each arm
Number of incident cases of asymptomatic SARS-CoV-2 infection among HCWs in each randomization arm.
Asymptomatic infection is defined as :
- a positive specific RT-PCR on periodic systematic nasopharyngeal swab during clinical follow-up without consistent clinical signs/symptoms during follow-up OR
- as seroconversion to SARS-CoV-2 between start and end of the study in HCWs that did not reported any consistent clinical symptoms during follow-up
Measured: Up to 2.5 months
Evaluation of the incidence of severe cases of SARS-CoV-2 infection in each arm.
Number of incident cases of severe SARS-CoV-2 infections among HCWs in each randomization arm, defined as :
- a positive specific RT-PCR on a respiratory sample OR
- a thoracic CT scan with imaging abnormalities consistent with COVID-19 performed in case of onset of symptoms consistent with COVID-19 during follow-up in a participant who need to be hospitalized for respiratory distress. Respiratory distress defined as dyspnea with a respiratory frequency > 30/min, blood oxygen saturation <93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300 and/or lung infiltrates >50% (1).
Measured: Up to 2.5 months
corrected QT interval (ms)
Safety. Electrocardiogram (ECG)
Measured: At baseline, at D2 (only for COVIDAXIS 1) and every week up to 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start14 Apr 2020
- Primary completion13 May 2020
- Study completion30 Mar 2022
Why it stopped: French authority's decision
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 Centre Hospitalier Universitaire de Saint EtienneThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized double-blind placebo-controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur
- Responsible party
- Sponsor
- Investigators
- Elisabeth Botelho-Nevers, MD, PhD, Principal investigator, CHU de Saint-EtienneBruno Hoen, MD, PhD, Study director, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328285
- Sponsor's protocol ID
- 20PH061
- Other IDs
- 2020-001188-96
- Acronym
- COVIDAXIS
- Status last verified
- Feb 2023
- First submitted
- 25 Mar 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers : A Randomized Double-blind Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04328285
- Acronym / sponsor ID
- COVIDAXIS / 20PH061
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, COVID-19, nasopharyngeal swab, pneumonia, Hydroxychloroquine, Lopinavir/ritonavir, Healthcare Workers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: French authority's decision
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Institut Pasteur
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 13 May 2020 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 31 Mar 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.
Since December 2019, the emergence of a new coronavirus named SARS-Cov-2 in the city of Wuhan in China has been responsible for a major epidemic of respiratory infections, including severe pneumonia. Within weeks, COVID-19 became a pandemic.
In the absence of specific antiviral treatment, a special attention should be given to prevention. Personal protection equipments may be insufficiently protective, including in healthcare workers, a significant proportion of whom (around 4%) having been infected in the outbreaks described in China and more recently in Italy. Infection in healthcare workers could result from the contact with COVID-19 people in community or with infected colleagues or patients.
As it will take at least a year before vaccines against SARS-CoV-2 becomes available, chemoprophylaxis is an option that should be considered in this setting where prevention of SARS-CoV-2 infection in Health Care Workers.
The COVIDAXIS trial evaluates a chemoprophylaxis of SARS-CoV-2 infection in Health Care Workers. This trial is divided into two distinct studies that could start independently each with its own randomization process: COVIDAXIS 1 will study Hydroxychloroquine (HCQ) versus placebo; COVIDAXIS 2 will study Lopinavir/ritonavir (LPV/r) versus placebo.
Upon randomization healthcare workers (HCWs) involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:
Detailed description
The study COVIDAXIS 1(Hydroxychloroquine (HCQ) versus placebo) will be realized on 600 participants and will be implemented first in as many centers as possible.
Upon randomization, with 1:1 allocation ratio, healthcare workers involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:
- Group 1.1: HCQ 200 mg : 2 tablets on the evening at Day 1 and 2 tablets on the morning at Day 2 and 1 tablet once daily afterwards
- Group 1.2: Placebo of HCQ, 2 tablets on the evening at Day 1 and 2 tablets on the morning at Day 2 and 1 tablet once daily afterwards.
The COVIDAXIS 2 (Lopinavir/ritonavir (LPV/r) versus placebo will be realized on 600 participants and will be implemented in already participating and newer centers in a second step (when LPV/r becomes available).
Upon randomization, with 1:1 allocation ratio, healthcare workers involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:
- Group 2.1: LPV/r 200/50 mg : 2 tablets twice daily
- Group 2.2: Placebo of LPV/r, 2 tablets twice daily
Participants will receive the randomized treatment for 2 months and will be followed upon a 2.5 months period.
NB: there is no randomization procedure for participant inclusion in either COVIDAXIS 1 or COVIDAXIS 2
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized double-blind placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine (HCQ) vs Placebo | Experimental | Drug: Hydroxychloroquine, Drug: Placebo of HydroxychloroquineGroup 1.1: HCQ 200 mg : 2 tablets on the evening at Day 1 and 2 tablets on the morning at Day 2 and 1 tablet once daily afterwards Group 1.2: Placebo of HCQ, 2 tablets on the evening at Day 1 and 2 tablets on the morning at Day 2 and 1 tablet once daily afterwards. |
| Lopinavir/ritonavir (LPV/r) vs Placebo | Experimental | Drug: Lopinavir and ritonavir, Drug: Placebo of LPV/r TabletsGroup 2.1: LPV/r 200/50 mg, 2 tablets twice daily Group 2.2: Placebo of LPV/r, 2 tablets twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult healthcare workers (HCWs) (for instance physicians, nurses, assistant nurses, dentists, physiotherapists, midwives, etc.)
- HCW involved at the time of enrolment in the care and the management of patients with confirmed or suspected SARS-CoV-2 infection in hospital settings, in outpatient care settings or in geriatric long-term care facilities. These HCWs have prolonged or repeated close contact to these patients.
- HCW tested negative for HIV
- HCW affiliated to the French health insurance system
- HCW women of childbearing age with an effective contraception (ethinylestradiol-containing contraceptive pills are not regarded as effective in the context of LPV/r treatment - COVIDAXIS 2)
Key exclusion criteria (23 listed)
- HCW with positive SARS-CoV-2 RT-PCR of nasopharyngeal swab at the inclusion visit.
- HCW with past history of confirmed SARS-CoV-2 infection
- HCW with positive SARS-CoV-2 serology at the inclusion visit
- HCW with comorbidities such as hypothyroidism that need hormonal substitution, or retinopathy or with prior intermittent porphyria, or chronic renal failure (glomerular filtration rate < 30mL/min) or prior hepatic failure or psoriasis.
- HCW with prior diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency
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 |
|---|---|---|
| HydroxychloroquineAlso: PlaquenilHydroxychloroquine Oral Tablets | Drug | Hydroxychloroquine (HCQ) vs Placebo |
| Placebo of HydroxychloroquinePlacebo of Hydroxychloroquine Oral Tablets Placebo manufactured to mimic Hydroxychloroquine tablets | Drug | Hydroxychloroquine (HCQ) vs Placebo |
| Lopinavir and ritonavirAlso: KaletraLPV/r Oral Tablets | Drug | Lopinavir/ritonavir (LPV/r) vs Placebo |
| Placebo of LPV/r TabletsPlacebo of LPV/r Oral Tablets Placebo manufactured to mimic LPV/r tablets | Drug | Lopinavir/ritonavir (LPV/r) vs Placebo |
Primary outcome
Occurrence of an symptomatic or asymptomatic SARS-CoV-2 infection among healthcare workers (HCWs)
Time frame: Up to 2.5 months
An infection by SARS-CoV-2 is defined by either: * a positive specific Reverse Transcription - Polymerase Chain Reaction (RT-PCR) on periodic systematic nasopharyngeal swab during follow-up OR * a positive specific RT-PCR on a respiratory sample in case of onset of symptoms consistent with COVID-19 during follow-up OR * a seroconversion to SARS-CoV-2 after randomization.
7 secondary outcomes
Evaluation of the occurrence of adverse events in each arm,
Time frame: Up to 2.5 months
Evaluation of the discontinuation rates of the investigational drug in each arm,
Time frame: Up to 2 months
Evaluation of the adherence of participants to study drug,
Time frame: Up to 2 months
Evaluation of the incidence of symptomatic cases of SARS-CoV-2 infection in each arm,
Time frame: Up to 2.5 months
Evaluation of the incidence of asymptomatic cases of SARS-CoV-2 infection in each arm
Time frame: Up to 2.5 months
Evaluation of the incidence of severe cases of SARS-CoV-2 infection in each arm.
Time frame: Up to 2.5 months
corrected QT interval (ms)
Time frame: At baseline, at D2 (only for COVIDAXIS 1) and every week up to 2 months.
Results and safety
The study was stopped early (reason given: French authority's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Elisabeth Botelho-Nevers, MD, PhD principal investigator
CHU de Saint-Etienne
Bruno Hoen, MD, PhD study director
Institut Pasteur
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine and Lopinavir and ritonavir in people with COVID-19, run by Centre Hospitalier Universitaire de Saint Etienne at 9 sites in France.
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 7 inclusion and 23 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: stopped early, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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 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 was stopped early (reason given: French authority's decision). Results are not available in the source record.
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?
Occurrence of an symptomatic or asymptomatic SARS-CoV-2 infection among healthcare workers (HCWs) (time frame: Up to 2.5 months). 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 1 Mar 2023.