COVIDPhase 3NCT04546581
Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)
A Phase 3 study testing Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) and Remdesivir in people with COVID and COVID-19, run by University of Minnesota at 39 sites in 7 countries.
Trial summary
This protocol will serve as a platform for assessing treatments for adult patients hospitalized for medical management of COVID-19 without related serious end-organ failure. Trials will involve sites around the world strategically chosen to ensure rapid enrollment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, COVID-19, SARS-CoV-2
- What is being tested?
- Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) and Remdesivir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 593 participants
- Where
- 39 sitesin 7 countries
- Study dates
- 8 Oct 2020to 21 May 2021
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SARS-CoV-2 infection documented by polymerase chain reaction (PCR) or other nucleic acid test (NAT) within 3 days prior to randomization OR documented by NAT more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection
- Symptomatic COVID-19 disease
- Duration of symptoms attributable to COVID-19 ≤ 12 days
- Requiring inpatient hospital medical care for clinical manifestations of COVID-19 (admission for public health or quarantine only is not included)
- Willingness to abstain from participation in other COVID-19 treatment trials until after study Day 7
- Provision of informed consent by participant or legally authorized representative
Who cannot join
- Prior receipt of SARS-CoV-2 hIVIG or convalescent plasma from a person who recovered from COVID-19 at any time
- Prior receipt of standard IVIG (not hyperimmune to SARS-CoV-2) within 45 days
- Current or predicted imminent (within 24 hours) requirement for any of the following:
- Invasive ventilation
- Non-invasive ventilation
- Extracorporeal membrane oxygenation
Show all 15Show fewer
- Mechanical circulatory support
- Continuous vasopressor therapy
- History of allergy to IVIG or plasma products
- History of selective IgA deficiency with documented presence of anti-IgA antibodies
- Any medical conditions for which receipt of the required volume of intravenous fluid may be dangerous to the patient (includes New York Association Class III or IV stage heart failure)
- Any of the following thrombotic or procoagulant disorders:
- Acute coronary syndromes, cerebrovascular syndromes and pulmonary or deep venous thrombosis within 28 days of randomization
- History of prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antithrombin III deficiency, protein C deficiency, protein S deficiency or antiphospholipid syndrome
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments
Trial locations and contacts
39 sites in 7 countries.
39 sites in 7 countries
United States18 sites
Hendrick Medical Center
Abilene, Texas, 79601
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Penrose Hospital
Colorado Springs, Colorado, 80907
St. Francis Health Services
Colorado Springs, Colorado, 80907
University of Missouri
Columbia, Missouri, 65212
Ohio Health Research Institute
Columbus, Ohio, 43215
CHRISTUS Spohn Shoreline Hospital
Corpus Christi, Texas, 78404
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
St. Anthony Hospital
Lakewood, Colorado, 80228
Hennepin Healthcare Research Institute/HCMC
Minneapolis, Minnesota, 55415
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28394
CJW Chippenham Medical Center
Richmond, Virginia, 23225
Henrico Doctors' Hospital (HCA)
Richmond, Virginia, 23229
Redmond Regional Medical Center
Rome, Georgia, 30165
Cox Medical Centers
Springfield, Missouri, 65807
Washington VA Medical Center
Washington D.C., District of Columbia, 20422
Saint Anthony North Health Campus
Westminster, Colorado, 80023
University of Massachusetts
Worcester, Massachusetts, 01665
Denmark8 sites
Aarhus Universitetshospital, Skejby
Aarhus
Bispebjerg Hospital
Copenhagen
CHIP, Department of Infectious Diseases, Section 2100
Copenhagen
Herlev-Gentofte Hospital
Hellerup
Nordsjællands Hospital, Hillerød
Hillerød, 3400
Hvidovre University Hospital, Department of Infectious Diseases
Hvidovre
Kolding Sygehus
Kolding
Odense University Hospital
Odense
Greece5 sites
Democritus University of Thrace
Alexandroupoli, Thrace, 68131
3rd Dept of Medicine, Medical School, NKUA
Athens, 11527
1st Respiratory Medicine Dept, Athens University Medical School
Athens
Attikon University General Hospital
Athens
Dept. of Critical Care & Pulmonary Medicine, Evangelismos General Hospital
Athens
Spain4 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, 08035
Hospital del Mar
Barcelona, 08002
Hospital Clínic de Barcelona
Barcelona, 08036
About this study
Official title: An International Multicenter, Adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized Patients at Onset of Clinical Progression of COVID-19
This protocol will serve as a platform for assessing treatments for adult patients hospitalized for medical management of COVID-19 without related serious end-organ failure. Trials will involve sites around the world strategically chosen to ensure rapid enrollment. This trial will compare hyperimmune intravenous immunoglobulin (hIVIG) with matched placebo, when added to standard of care (SOC), for preventing further disease progression and mortality related to COVID-19. SOC will include remdesivir unless it is contraindicated for an individual patient.
Read the detailed description
The primary endpoint of this trial in hospitalized patients is an ordinal outcome based on the patient's clinical status on Day 7. It includes 7 mutually exclusive categories capturing the range of organ dysfunction that may be associated with progression of COVID-19, such as respiratory dysfunction and coagulation-related complications. The ordinal endpoint is defined as follows:
- Death
- End-organ failure
- Life-threatening end-organ dysfunction
- Serious end-organ dysfunction
- Moderate end-organ dysfunction
- Limiting symptoms due to COVID-19
- No limiting symptoms due to COVID-19
Secondary endpoints include time to the 3 least favorable categories, time to the 2 most favorable categories, and the pulmonary only and thrombotic only components of the primary ordinal outcome. Mortality, adverse events (AEs), including infusion reactions, and biological correlates of therapeutic activity are also assessed. Because there is no established endpoint for evaluating the clinical efficacy of treatments for COVID-19, other clinically relevant outcomes, including outcomes used in other COVID-19 treatment trials, will be recorded. Thus, the randomized groups (hIVIG + SOC versus placebo + SOC ) can be compared for multiple outcomes, and results can be compared or combined with other trials.
Participants will be randomized (1:1) to a single infusion of hIVIG + SOC or placebo + SOC on the day of randomization (Day 0). Participants taking remdesivir prior to randomization may be enrolled if eligibility criteria are met. Randomized participants who were not taking remdesivir before randomization will start taking remdesivir immediately following the infusion of hIVIG or placebo unless remdesivir is contraindicated. Participants will be followed for 28 days and, if the trial goes to completion, the primary analysis will be completed after all participants are followed for 28 days.
- Conditions
- COVID, COVID-19, SARS-CoV-2, SARS (Severe Acute Respiratory Syndrome)
- Being tested
- Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG), Placebo, Remdesivir
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)Biological
Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion.
PlaceboOther
Participants will receive a single infusion of the placebo (saline).
RemdesivirDrug
Remdesivir will be given to participants in both groups as standard of care (SOC).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in this group will receive the investigational product and standard of care (SOC). Receives: Biological: Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG); Drug: Remdesivir |
| Control Group | Placebo comparator | Participants in this group will receive a placebo and standard of care (SOC). Receives: Other: Placebo; Drug: Remdesivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ordinal Outcome Scale - Day 7
The primary objective is to compare the clinical status of patients in each group on day 7 of follow-up using the primary ordinal outcome with 7 mutually exclusive categories:
- Death 6. End-organ failure 5. Life-threatening end-organ dysfunction 4. Serious end-organ dysfunction 3. Moderate end-organ dysfunction 2. Limiting symptoms due to COVID-19
- No limiting symptoms due to COVID-19
Outcome is reported as the percent of participants in each of 7 categories. Primary ordinal outcome based on the patient's clinical status on Day 7. It includes 7 mutually exclusive categories capturing the range of organ dysfunction that may be associated with progression of COVID-19, such as respiratory dysfunction and coagulation-related complications.
Minimum value = 1, Maximum value = 7 Higher scores mean a worse outcome
Measured: 7 days
Primary Safety Outcome - Death, SAE or Grade 3 or 4 Events Through Day 7
Number of participants with death, SAE or Grade 3 or 4 event through Day 7
Measured: Through Day 7
Secondary outcomes (3)
N Reaching 3 Least Favorable Categories
N Reaching 3 least favorable categories of ordinal outcome (Categories 5, 6, 7: life-threatening end organ dysfunction, end organ failure, or death)
Measured: All of follow-up (through Day 28)
N Reaching 2 Most Favorable Categories
N Reaching 2 most favorable categories of ordinal outcome (Categories 1 and 2: not requiring oxygen with or without limiting symptoms due to COVID-19)
Measured: All of follow-up (through Day 28)
N Discharged or in Most Favorable Category
N discharged from hospital or reaching most favorable ordinal category (category 1: not requiring oxygen and no limiting symptoms due to COVID-19)
Measured: All of follow-up (through Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start8 Oct 2020
- Primary completion21 May 2021
- Study completion21 May 2021
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 (3)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 593 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
- Responsible party
- Sponsor
- Investigators
- James Neaton, PhD, Principal investigator, University of MinnesotaMark Polizzotto, MD, Study chair, Kirby Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546581
- Sponsor's protocol ID
- INSIGHT 013
- Status last verified
- Mar 2022
- First submitted
- 8 Sep 2020
- Last updated
- 4 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: A public data set will be made available at the end of the trial
Publications
Jha A, Barker D, Lew J, Manoharan V, van Kessel J, Haupt R, Toth D, Frieman M, Falzarano D, Kodihalli S. Efficacy of COVID-HIGIV in animal models of SARS-CoV-2 infection. Sci Rep. 2022 Oct 10;12(1):16956. doi: 10.1038/s41598-022-21223-2.
PubMed 36216961ITAC (INSIGHT 013) Study Group. Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial. Lancet. 2022 Feb 5;399(10324):530-540. doi: 10.1016/S0140-6736(22)00101-5. Epub 2022 Jan 28.
PubMed 35093205Vandeberg P, Cruz M, Diez JM, Merritt WK, Santos B, Trukawinski S, Wellhouse A, Jose M, Willis T. Production of anti-SARS-CoV-2 hyperimmune globulin from convalescent plasma. Transfusion. 2021 Jun;61(6):1705-1709. doi: 10.1111/trf.16378. Epub 2021 Mar 22.
PubMed 33715160
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Multicenter, Adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized Patients at Onset of Clinical Progression of COVID-19
- ClinicalTrials.gov ID
- NCT04546581
- Acronym / sponsor ID
- INSIGHT 013
- Conditions
- COVID, COVID-19, SARS-CoV-2, SARS (Severe Acute Respiratory Syndrome)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 593 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Posted 4 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol will serve as a platform for assessing treatments for adult patients hospitalized for medical management of COVID-19 without related serious end-organ failure. Trials will involve sites around the world strategically chosen to ensure rapid enrollment. This trial will compare hyperimmune intravenous immunoglobulin (hIVIG) with matched placebo, when added to standard of care (SOC), for preventing further disease progression and mortality related to COVID-19. SOC will include remdesivir unless it is contraindicated for an individual patient.
Detailed description
The primary endpoint of this trial in hospitalized patients is an ordinal outcome based on the patient's clinical status on Day 7. It includes 7 mutually exclusive categories capturing the range of organ dysfunction that may be associated with progression of COVID-19, such as respiratory dysfunction and coagulation-related complications. The ordinal endpoint is defined as follows:
- Death
- End-organ failure
- Life-threatening end-organ dysfunction
- Serious end-organ dysfunction
- Moderate end-organ dysfunction
- Limiting symptoms due to COVID-19
- No limiting symptoms due to COVID-19
Secondary endpoints include time to the 3 least favorable categories, time to the 2 most favorable categories, and the pulmonary only and thrombotic only components of the primary ordinal outcome. Mortality, adverse events (AEs), including infusion reactions, and biological correlates of therapeutic activity are also assessed. Because there is no established endpoint for evaluating the clinical efficacy of treatments for COVID-19, other clinically relevant outcomes, including outcomes used in other COVID-19 treatment trials, will be recorded. Thus, the randomized groups (hIVIG + SOC versus placebo + SOC ) can be compared for multiple outcomes, and results can be compared or combined with other trials.
Participants will be randomized (1:1) to a single infusion of hIVIG + SOC or placebo + SOC on the day of randomization (Day 0). Participants taking remdesivir prior to randomization may be enrolled if eligibility criteria are met. Randomized participants who were not taking remdesivir before randomization will start taking remdesivir immediately following the infusion of hIVIG or placebo unless remdesivir is contraindicated. Participants will be followed for 28 days and, if the trial goes to completion, the primary analysis will be completed after all participants are followed for 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Biological: Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG), Drug: RemdesivirParticipants in this group will receive the investigational product and standard of care (SOC). |
| Control Group | Placebo comparator | Other: Placebo, Drug: RemdesivirParticipants in this group will receive a placebo and standard of care (SOC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- SARS-CoV-2 infection documented by polymerase chain reaction (PCR) or other nucleic acid test (NAT) within 3 days prior to randomization OR documented by NAT more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection
- Symptomatic COVID-19 disease
- Duration of symptoms attributable to COVID-19 ≤ 12 days
- Requiring inpatient hospital medical care for clinical manifestations of COVID-19 (admission for public health or quarantine only is not included)
- Willingness to abstain from participation in other COVID-19 treatment trials until after study Day 7
Key exclusion criteria (15 listed)
- Prior receipt of SARS-CoV-2 hIVIG or convalescent plasma from a person who recovered from COVID-19 at any time
- Prior receipt of standard IVIG (not hyperimmune to SARS-CoV-2) within 45 days
- Current or predicted imminent (within 24 hours) requirement for any of the following:
- History of allergy to IVIG or plasma products
- History of selective IgA deficiency with documented presence of anti-IgA antibodies
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 |
|---|---|---|
| Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion. | Biological | Intervention Group |
| PlaceboParticipants will receive a single infusion of the placebo (saline). | Other | Control Group |
| RemdesivirRemdesivir will be given to participants in both groups as standard of care (SOC). | Drug | Control Group, Intervention Group |
Primary outcome
Ordinal Outcome Scale - Day 7
Time frame: 7 days
The primary objective is to compare the clinical status of patients in each group on day 7 of follow-up using the primary ordinal outcome with 7 mutually exclusive categories: 7. Death 6. End-organ failure 5. Life-threatening end-organ dysfunction 4. Serious end-organ dysfunction 3. Moderate end-organ dysfunction 2. Limiting symptoms due to COVID-19 1. No limiting symptoms due to COVID-19 Outcome is reported as the percent of participants in each of 7 categories. Primary ordinal outcome based on the patient's clinical status on Day 7. It includes 7 mutually exclusive categories capturing the range of organ dysfunction that may be associated with progression of COVID-19, such as respiratory dysfunction and coagulation-related complications. Minimum value = 1, Maximum value = 7 Higher scores mean a worse outcome
Primary Safety Outcome - Death, SAE or Grade 3 or 4 Events Through Day 7
Time frame: Through Day 7
Number of participants with death, SAE or Grade 3 or 4 event through Day 7
3 secondary outcomes
N Reaching 3 Least Favorable Categories
Time frame: All of follow-up (through Day 28)
N Reaching 2 Most Favorable Categories
Time frame: All of follow-up (through Day 28)
N Discharged or in Most Favorable Category
Time frame: All of follow-up (through Day 28)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36216961Jha A, Barker D, Lew J, Manoharan V, van Kessel J, Haupt R, Toth D, Frieman M, Falzarano D, Kodihalli S. Efficacy of COVID-HIGIV in animal models of SARS-CoV-2 infection. Sci Rep. 2022 Oct 10;12(1):16956. doi: 10.1038/s41598-022-21223-2.
- Derived from this study: PubMed 35093205ITAC (INSIGHT 013) Study Group. Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial. Lancet. 2022 Feb 5;399(10324):530-540. doi: 10.1016/S0140-6736(22)00101-5. Epub 2022 Jan 28.
- Derived from this study: PubMed 33715160Vandeberg P, Cruz M, Diez JM, Merritt WK, Santos B, Trukawinski S, Wellhouse A, Jose M, Willis T. Production of anti-SARS-CoV-2 hyperimmune globulin from convalescent plasma. Transfusion. 2021 Jun;61(6):1705-1709. doi: 10.1111/trf.16378. Epub 2021 Mar 22.
- Individual participant dataSharing planned: Yes. A public data set will be made available at the end of the trial
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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.
James Neaton, PhD principal investigator
University of Minnesota
Mark Polizzotto, MD study chair
Kirby Institute
39 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) and Remdesivir in people with COVID and COVID-19, run by University of Minnesota at 39 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 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 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Denmark, Greece, Spain, Japan and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2022). 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?
Ordinal Outcome Scale - Day 7 (time frame: 7 days). The study lists 2 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 NCT04546581, which also lists 3 linked publications.
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 4 Apr 2022.