H1N1 Influenza Healthy VolunteersPhase 2CR6261NCT02371668
Efficacy and Safety of CR6261 in an H1N1 Influenza Healthy Volunteer Human Challenge Model
A Phase 2 study testing CR6261 in people with H1N1 Influenza Healthy Volunteers, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: Researchers want to see if a new drug reduces flu disease in people treated with this drug versus a placebo. The drug has an antibody that may help the immune system fight the flu. Placebo is only sugar and water. All participants will get the flu virus. They may or may not develop flu symptoms. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- H1N1 Influenza Healthy Volunteers
- What is being tested?
- CR6261
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2015to 30 Nov 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Presence of self-reported or medically documented significant medical condition including but not limited to:
- Chronic pulmonary disease (e.g., asthma, emphysema).
- Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
- Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (e.g., insulin dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
- Immunosuppression or ongoing malignancy.
- Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
Show all 42Show fewer
- Postinfectious or postvaccine neurological sequelae.
- Hyperlipidemia requiring medical therapy per current American College of Cardiology (ACC) and American Heart Association (AHA) guidelines published in 2013.
- Have close or household (i.e., share the same apartment or house) high-risk contacts including but not limited to:
- Persons greater than or equal to 65 years of age.
- Children less than or equal to 5 years of age.
- Residents of nursing homes.
- Persons of any age with significant chronic medical conditions such as:
- Chronic pulmonary disease (e.g., severe asthma, COPD).
- Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
- Contacts who required medical follow-up or hospitalization during the past 5 years because of chronic metabolic disease (e.g., insulin dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
- Immunosuppression or cancer.
- Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
- Individuals who are receiving long-term aspirin therapy.
- Women who are pregnant or who are trying to become pregnant.
- Positive serology for hepatitis C virus antibody or hepatitis B surface antigen.
- Individual with body mass index (BMI) greater than or equal to 18 and greater than or equal to 35 or weight > 114kg.
- Acute illness within 7 days of admission and inoculation with the challenge virus (Day -1).
- Complete blood count (CBC) with differential outside of the NIH Department of Laboratory Medicine (DLM) normal reference range and deemed clinically significant by the PI.
- Chemistries in the acute care, mineral, and/or hepatic panels, and/or any of the following: lactate dehydrogenase, uric acid, creatine kinase, and total protein outside of the NIH DLM normal reference range and deemed clinically significant by the PI.
- Amylase or Lipase outside of the NIH DLM normal reference range and deemed clinically significant by the PI.
- Urinalysis outside of the NIH DLM normal reference range and deemed clinically significant by the PI.
- Clinically significant abnormality as deemed by the PI on electrocardiogram.
- Clinically significant abnormality as deemed by the PI on echocardiographic (ECHO) testing.
- Clinically significant abnormality as deemed by the PI on the Pulmonary Function Test (PFT).
- Known allergy to treatments for influenza (including but not limited to oseltamivir, nonsteroidals).
- Known allergy to 2 or more classes of antibiotics (e.g., penicillins, cephalosporins, fluoroquinolones, or glycopeptides).
- Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment.
- Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is greater) prior to enrollment.
- Receipt of any non-influenza-related unlicensed vaccine within 6 months prior to enrollment.
- Self-reported or known history of current alcoholism or drug abuse, or positive urine/serum test for drugs of abuse and/or ethanol (i.e., amphetamines, cocaine, benzodiazepines, opiates, or metabolites, but not tetrahydrocannabinol (THC) or metabolites).
- Self-reported or known history of psychiatric or psychological issues deemed by the PI to be a contraindication to protocol participation.
- 19. Known close contact with anyone known to have influenza in the past 7 days.
- 21. Known or suspected hypersensitivity to CR6261 or its excipients (sucrose, L-histidine, L-histidine monohydrochloride, polysorbate 20).
- 22. History of a previous severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
- 23. Drinks more than 1200 mL (or 5 cups of 240 mL per cup) of tea/coffee/cocoa/cola or other caffeinated beverage per day more than 1 day per week in the 2 weeks before screening.
- 24. Any condition or event that, in the judgment of the PI, is a contraindication to protocol participation or impairs the volunteer s ability to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study in Healthy Volunteers to Evaluate the Efficacy and Safety of CR6261 in an H1N1 Influenza Healthy Human Challenge Model
Background:
- Researchers want to see if a new drug reduces flu disease in people treated with this drug versus a placebo. The drug has an antibody that may help the immune system fight the flu. Placebo is only sugar and water. All participants will get the flu virus. They may or may not develop flu symptoms.
Read more
Objective:
- To see if the drug CR6261 reduces flu disease in people treated with this drug versus a placebo.
Eligibility:
- Healthy nonsmokers ages 18 45.
Design:
- Participants will be screened under a separate protocol.
- Participants must use contraception or abstinence for several weeks before and after the study. They must have no alcohol for 1 day before each visit. Any medicine must be approved by the study doctor until after follow-up.
- Participants will stay in a hospital isolation unit for at least 10 days.
- They will have:
- Medical history
- Physical exam
- Blood and urine tests
- Heart and lung test
- Tests for drugs and alcohol
- Throughout their stay, participants will:
- Be closely watched by a medical team
- Have nasal washes and swabs several times a day
- Participants will have the flu virus sprayed in each nostril.
- The next day, participants will get either study drug or placebo through a soft plastic tube placed in a vein by needle. It will take 2 hours. They will not know which they get.
- Participants can go home after 10 days if they test negative for the flu 2 days in a row.
- Participants will have daily questionnaires at home and 2 follow-up visits over 2 months.
Read the detailed description
The high morbidity and mortality associated with both pandemic and seasonal influenza and the threat of new potentially pandemic strains emerging makes influenza an important infectious disease and public health problem. Mean annual estimates of influenza deaths due to seasonal influenza alone attributes up to 49,000 deaths in the US and 250,000 to 500,000 deaths in industrialized countries to influenza. Pandemics can have an even more devastating effect. Public health agencies must continue to be prepared by making attempts to reduce the public health impact of this important virus.
In the realm of influenza therapeutics, antiviral drugs are currently used to treat influenza infection in those who fail to be protected by current vaccines or those who do not receive a vaccine. Currently, only two classes of antivirals are FDA approved for the treatment of influenza A: neuraminidase inhibitors and matrix M2 channel blockers. Although these drugs have been shown to be effective in reducing influenza illness by 24-48 hours and reducing shedding in relatively healthy adults, as with vaccination, they have had limited effectiveness in high risk groups and those who have severe or complicated influenza infections. In addition, antiviral resistance has become very common in human influenza A viruses, as currently circulating H1N1 and H3N2 strains are resistant to the adamantane M2 channel blockers and many cases of neuraminidase inhibitor resistance have also been reported with strains of both subtypes. This resistance can develop quickly and in most cases only requires a single amino acid change. Given these significant issues with currently available treatments, novel therapies for influenza are clearly needed.
Live virus challenge studies have played a pivotal role in developing influenza therapeutics in the past, and they will be instrumental in the future. No novel therapeutic or prophylactic agent has been FDA-approved since the last influenza challenge studies ceased over a decade ago. In collaboration with the Crucell Vaccine Institute (part of Crucell which is in the Janssen family of Pharmaceutical Companies of Johnson \& Johnson) this protocol will evaluate mAb CR6261 for possible therapeutic value. Unlike the current antivirals that are compounds which interfere with some portion of the viral replicative cycle, this agent is a mAb that targets the stem of HA, neutralizing the virus by stabilizing the pre-fusion state and preventing the pH-dependent fusion of viral and cellular membranes. Pre-clinical data suggest that this mAb has good cross-protective efficacy with a variety of HA subtypes unlike current vaccines, making it potentially effective in the event of an emerging influenza virus outbreak with a novel HA subtype. In addition, the conserved nature of the HA stem region suggests that amino acid changes conferring resistance are much less likely. We will effort to demonstrate that CR6261 leads to improved outcomes compared with placebo with respect to the AUC of virus shedding as determined by qPCR in NP swabs in all treated subjects.
- Conditions
- H1N1 Influenza Healthy Volunteers
- Being tested
- CR6261, Placebo
- Keywords
- Influenza A, H1N1, Challenge Model, Human Immunoglobulin and H1N1, Efficacy and Safety in H1N1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CR6261Biological
50 mg/kg administered as a single 2-hour intravenous infusion on Day 1 (24 hours after virus administration).
PlaceboBiological
Administered as a single 2-hour intravenous infusion on Day 1 (24 hours after virus administration).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo, 5% dextrose (D-glucose) water Receives: Biological: Placebo |
| CR6261 | Experimental | CR6261, Investigational monoclonal antibody against influenza A viruses Receives: Biological: CR6261 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) of Viral Shedding
Area under the curve (AUC) calculated from quantitative real-time RT-PCR for influenza A taken from 3 time per day nasal swab collection.
Measured: 3 times a day for 10 days
Secondary outcomes (8)
Confirmed Influenza Infection
Percentage of participants who experienced either viral shedding or symptoms + a four fold rise in convalescent HAI titer.
Measured: Evaluated daily for 10 days + 8 weeks convalescent follow up
Days of Shedding
Duration in days viral shedding was detected after influenza challenge
Measured: Evaluated for up to 2 months
Days of Symptoms
Duration in days symptoms were experienced after influenza challenge
Measured: Evaluated for up to 2 months
Mild to Moderate Influenza Disease
Percentage of participants who experienced influenza symptoms and shedding
Measured: Evaluated daily for 10 days
Number of Symptoms
Number of unique influenza symptoms experienced after influenza challenge
Measured: Evaluated for up to 2 months
Symptoms
Percentage of participants who experienced influenza symptoms
Measured: Evaluated daily for 10 days
Total FLUPRO Score
Objective symptoms score from patient directed FLUPRO questionnaire (inFLUenza Patient-Reported Outcome dairy) . The FLUPRO questionnaire uses a 5-point ordinal scale, with higher scores indicating a more frequent sign or symptom. Total scores can range from 0 (symptom free) to 4 (maximum severity of symptoms). Daily scores (Day 0 - Day 8) are averaged to calculate a total score for each participant, then calculated the median total FLUPRO score for each arm.
Measured: Evaluated from day 0 to day 8
Viral Shedding
Percentage of participants who experienced influenza viral shedding
Measured: Evaluated daily for 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study start25 Feb 2015
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for H1N1 Influenza Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Matthew J Memoli, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371668
- Sponsor's protocol ID
- 150069
- Other IDs
- 15-I-0069
- Acronym
- CR6261
- Status last verified
- 30 Nov 2018
- First submitted
- 25 Feb 2015
- Last updated
- 17 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Han A, Czajkowski L, Rosas LA, Cervantes-Medina A, Xiao Y, Gouzoulis M, Lumbard K, Hunsberger S, Reed S, Athota R, Baus HA, Lwin A, Sadoff J, Taubenberger JK, Memoli MJ. Safety and Efficacy of CR6261 in an Influenza A H1N1 Healthy Human Challenge Model. Clin Infect Dis. 2021 Dec 6;73(11):e4260-e4268. doi: 10.1093/cid/ciaa1725.
PubMed 33211860
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study in Healthy Volunteers to Evaluate the Efficacy and Safety of CR6261 in an H1N1 Influenza Healthy Human Challenge Model
- ClinicalTrials.gov ID
- NCT02371668
- Acronym / sponsor ID
- CR6261 / 150069
- Conditions
- H1N1 Influenza Healthy Volunteers
- Keywords
- Influenza A, H1N1, Challenge Model, Human Immunoglobulin and H1N1, Efficacy and Safety in H1N1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 25 Feb 2015
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Posted 17 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Researchers want to see if a new drug reduces flu disease in people treated with this drug versus a placebo. The drug has an antibody that may help the immune system fight the flu. Placebo is only sugar and water. All participants will get the flu virus. They may or may not develop flu symptoms.
Objective:
- To see if the drug CR6261 reduces flu disease in people treated with this drug versus a placebo.
Eligibility:
- Healthy nonsmokers ages 18 45.
Design:
- Participants will be screened under a separate protocol.
- Participants must use contraception or abstinence for several weeks before and after the study. They must have no alcohol for 1 day before each visit. Any medicine must be approved by the study doctor until after follow-up.
- Participants will stay in a hospital isolation unit for at least 10 days.
- They will have:
- Medical history
- Physical exam
- Blood and urine tests
- Heart and lung test
- Tests for drugs and alcohol
- Throughout their stay, participants will:
- Be closely watched by a medical team
- Have nasal washes and swabs several times a day
- Participants will have the flu virus sprayed in each nostril.
- The next day, participants will get either study drug or placebo through a soft plastic tube placed in a vein by needle. It will take 2 hours. They will not know which they get.
- Participants can go home after 10 days if they test negative for the flu 2 days in a row.
- Participants will have daily questionnaires at home and 2 follow-up visits over 2 months.
Detailed description
The high morbidity and mortality associated with both pandemic and seasonal influenza and the threat of new potentially pandemic strains emerging makes influenza an important infectious disease and public health problem. Mean annual estimates of influenza deaths due to seasonal influenza alone attributes up to 49,000 deaths in the US and 250,000 to 500,000 deaths in industrialized countries to influenza. Pandemics can have an even more devastating effect. Public health agencies must continue to be prepared by making attempts to reduce the public health impact of this important virus.
In the realm of influenza therapeutics, antiviral drugs are currently used to treat influenza infection in those who fail to be protected by current vaccines or those who do not receive a vaccine. Currently, only two classes of antivirals are FDA approved for the treatment of influenza A: neuraminidase inhibitors and matrix M2 channel blockers. Although these drugs have been shown to be effective in reducing influenza illness by 24-48 hours and reducing shedding in relatively healthy adults, as with vaccination, they have had limited effectiveness in high risk groups and those who have severe or complicated influenza infections. In addition, antiviral resistance has become very common in human influenza A viruses, as currently circulating H1N1 and H3N2 strains are resistant to the adamantane M2 channel blockers and many cases of neuraminidase inhibitor resistance have also been reported with strains of both subtypes. This resistance can develop quickly and in most cases only requires a single amino acid change. Given these significant issues with currently available treatments, novel therapies for influenza are clearly needed.
Live virus challenge studies have played a pivotal role in developing influenza therapeutics in the past, and they will be instrumental in the future. No novel therapeutic or prophylactic agent has been FDA-approved since the last influenza challenge studies ceased over a decade ago. In collaboration with the Crucell Vaccine Institute (part of Crucell which is in the Janssen family of Pharmaceutical Companies of Johnson \& Johnson) this protocol will evaluate mAb CR6261 for possible therapeutic value. Unlike the current antivirals that are compounds which interfere with some portion of the viral replicative cycle, this agent is a mAb that targets the stem of HA, neutralizing the virus by stabilizing the pre-fusion state and preventing the pH-dependent fusion of viral and cellular membranes. Pre-clinical data suggest that this mAb has good cross-protective efficacy with a variety of HA subtypes unlike current vaccines, making it potentially effective in the event of an emerging influenza virus outbreak with a novel HA subtype. In addition, the conserved nature of the HA stem region suggests that amino acid changes conferring resistance are much less likely. We will effort to demonstrate that CR6261 leads to improved outcomes compared with placebo with respect to the AUC of virus shedding as determined by qPCR in NP swabs in all treated subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: PlaceboPlacebo, 5% dextrose (D-glucose) water |
| CR6261 | Experimental | Biological: CR6261CR6261, Investigational monoclonal antibody against influenza A viruses |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (42 listed)
- Presence of self-reported or medically documented significant medical condition including but not limited to:
- Have close or household (i.e., share the same apartment or house) high-risk contacts including but not limited to:
- Positive serology for hepatitis C virus antibody or hepatitis B surface antigen.
- Individual with body mass index (BMI) greater than or equal to 18 and greater than or equal to 35 or weight > 114kg.
- Acute illness within 7 days of admission and inoculation with the challenge virus (Day -1).
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 |
|---|---|---|
| CR626150 mg/kg administered as a single 2-hour intravenous infusion on Day 1 (24 hours after virus administration). | Biological | CR6261 |
| PlaceboAdministered as a single 2-hour intravenous infusion on Day 1 (24 hours after virus administration). | Biological | Placebo |
Primary outcome
Area Under the Curve (AUC) of Viral Shedding
Time frame: 3 times a day for 10 days
Area under the curve (AUC) calculated from quantitative real-time RT-PCR for influenza A taken from 3 time per day nasal swab collection.
8 secondary outcomes
Confirmed Influenza Infection
Time frame: Evaluated daily for 10 days + 8 weeks convalescent follow up
Days of Shedding
Time frame: Evaluated for up to 2 months
Days of Symptoms
Time frame: Evaluated for up to 2 months
Mild to Moderate Influenza Disease
Time frame: Evaluated daily for 10 days
Number of Symptoms
Time frame: Evaluated for up to 2 months
Symptoms
Time frame: Evaluated daily for 10 days
Total FLUPRO Score
Time frame: Evaluated from day 0 to day 8
Viral Shedding
Time frame: Evaluated daily for 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33211860Han A, Czajkowski L, Rosas LA, Cervantes-Medina A, Xiao Y, Gouzoulis M, Lumbard K, Hunsberger S, Reed S, Athota R, Baus HA, Lwin A, Sadoff J, Taubenberger JK, Memoli MJ. Safety and Efficacy of CR6261 in an Influenza A H1N1 Healthy Human Challenge Model. Clin Infect Dis. 2021 Dec 6;73(11):e4260-e4268. doi: 10.1093/cid/ciaa1725.
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.
Matthew J Memoli, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CR6261 in people with H1N1 Influenza Healthy Volunteers, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 0 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 17 Mar 2020. 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 United States. 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 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?
Yes. Results are posted in the registry (first posted 17 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Area Under the Curve (AUC) of Viral Shedding (time frame: 3 times a day for 10 days). 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 NCT02371668, which also lists 1 linked publication.
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 17 Mar 2020.