Severe Acute Respiratory Syndrome Coronavirus 2Phase 2DMMETCOV19NCT04626089
Metformin Glycinate in Patients With MS or DM2 , Hospitalized With COVID-19 and SARS Secondary to SARS-CoV-2
A Phase 2 study testing metformin glycinate in people with Severe Acute Respiratory Syndrome Coronavirus 2 and Metabolic Syndrome, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of metformin glycinate at dose of 620 mg twice per day plus standard treatment comparing to standard treatment alone (we will use placebo) of patients who have metabolic syndrome or type 2 diabetes, which have severe acute respiratory syndrome secondary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2, Metabolic Syndrome, Type 2 Diabetes
- What is being tested?
- metformin glycinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Feb 2021to Feb 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- Ability to understand and the willingness to sign a written informed consent document before any study procedure
- Metabolic syndrome or type 2 diabetes
- Coronavirus infection, severe acute respiratory syndrome SARS-CoV- 2 confirmed by the Polymerase Chain Reaction test (PCR) ≤ 4 days before of the randomization.
- Hospitalized patient.
- Radiographic evidence of pulmonary infiltrates
Who cannot join
- Participation in any other clinical trial of an experimental treatment for COVID-19
- Evidence of multi-organ failure
- Require mechanical ventilation before randomization
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptive Study for Efficacy and Safety of Metformin Glycinate for the Treatment of Patients With MS and DM2, Hospitalized With Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2. Randomized, Double-Blind, Phase IIIb.
The purpose of this study is to evaluate the efficacy and safety of metformin glycinate at dose of 620 mg twice per day plus standard treatment comparing to standard treatment alone (we will use placebo) of patients who have metabolic syndrome or type 2 diabetes, which have severe acute respiratory syndrome secondary to SARS-CoV-2.
Read the detailed description
After being informed about the study and potential risks, all patients will give written informed consent and undergo a 1 day screening period to determine the eligibility for study entry. At day 0, patients who meet the eligibility requirements will be randomized in a double blind (participant and investigator) in a 1:1 ratio to metformin glycinate (620 mg, taken orally twice daily) plus standard treatment or placebo (taken orally,twice daily) plus standard treatment, both will be for 14 days.
- Being tested
- metformin glycinate, Placebo oral tablet
- Keywords
- SARS-CoV 2, Metabolic Syndrome, Type 2 diabetes, Severe Acute Respiratory Syndrome, Metformin glycinate
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Type 2, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metformin glycinateDrug
Also called DMMET
Participants randomized to metformin glycinate wil take 620 mg bid (PO) plus standard treatment for 14 days
Placebo oral tabletDrug
Also called Placebo
Participants randomized to placebo will take a tablet bid (PO) plus standard treatment for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Metformin glycinate | Experimental | 620 mg bid (PO) plus standard treatment for 14 days Receives: Drug: metformin glycinate |
| Placebo | Placebo comparator | Placebo tablets bid (PO) plus standard treatment for 14 days Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Load
Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate
Measured: Day 0 to Day 8 or patient discharge day
Secondary outcomes (11)
Days of supplementary oxygen if apply
Assess length of supplementary oxygen
Measured: Day 0 to day 28 or patient discharge day
Days of supplementary mechanical ventilation if apply
Assess length of mechanical ventilation
Measured: Day 0 to day 28 or patient discharge day
Days of Hospitalization
Assess length of hospitalization
Measured: Day 0 to day 28 or patients discharge day
Normalization of fever
Assess the difference in the Proportion of participants with normalization of fever between participants that receive placebo vs the patients with metformin glycinate
Measured: Day 0 to day 28 or patient discharge day
Normalization of oxigen saturation
Assess the difference in the Proportion of participants with normalization of oxygen saturation between participants that receive placebo vs the patients with metformin glycinate
Measured: Day 0 to day 28 or patient discharge day
Number of deaths
Assess the difference in the number of deaths between participants who received placebo versus the patients with metformin glycinate
Measured: Day 0 to day 28 or patient discharge day
Change in Serum creatinine levels
Evaluate if the level increase or decrease in serum creatinine compared to baseline. units: mg/dl
Measured: Day 0 to day 28 or patients discharge day
Change in serum Troponin I
Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l
Measured: Day 0 to day 28 or patients discharge day
Change in serum aspartate aminotransferase levels
Evaluate if the level increase or decrease in serum aspartate aminotransferase compared to baseline. units: IU/l
Measured: Day 0 to day 28 or patients discharge day
Change in serum Creatine kinase-MB levels
Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l
Measured: Day 0 to day 28 or patients discharge day
Incidence of adverse event
Assess by incidence of grade 3, grade 4 and Serious adverse events
Measured: Day 0 to day 28 or patients discharge day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study startFeb 2021 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Why it stopped: Administrative decision of the company
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Severe Acute Respiratory Syndrome Coronavirus 2Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group: Metformin glycinate 620 mg bid (PO) plus standard treatment for 14 days. Control Group: Placebo bid (PO) plus standard treatment for 14 days plus
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fausto González-Villagrán, MD, Principal investigator, Hospital Juárez de México, OPD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626089
- Sponsor's protocol ID
- SIL-30000-II(1)
- Acronym
- DMMETCOV19
- Status last verified
- Nov 2020
- First submitted
- 23 Oct 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Revert F, Ventura I, Martinez-Martinez P, Granero-Molto F, Revert-Ros F, Macias J, Saus J. Goodpasture antigen-binding protein is a soluble exportable protein that interacts with type IV collagen. Identification of novel membrane-bound isoforms. J Biol Chem. 2008 Oct 31;283(44):30246-55. doi: 10.1074/jbc.M805026200. Epub 2008 Sep 4.
PubMed 18772132Glucophage Product Monograph (metformin hydrochloride) Sanofi-Aventis Canada. Rev.28th October 2008
NDA 20-357, Glucophage. US Food and Drug Administration. Center for Drug Evaluation and Research. Freedom of Information Office. New Drug Approval Packages. Pharmacology/Toxicology Review.
NDA 21-842, Actoplus met. US Food and Drug Administration. Center for Drug Evaluation and Research. Freedom of Information Office. New Drug Approval Packages. Pharmacology/Toxicology Review.
Saus J, Wieslander J, Langeveld JP, Quinones S, Hudson BG. Identification of the Goodpasture antigen as the alpha 3(IV) chain of collagen IV. J Biol Chem. 1988 Sep 15;263(26):13374-80.
PubMed 3417661Hudson BG, Tryggvason K, Sundaramoorthy M, Neilson EG. Alport's syndrome, Goodpasture's syndrome, and type IV collagen. N Engl J Med. 2003 Jun 19;348(25):2543-56. doi: 10.1056/NEJMra022296. No abstract available.
PubMed 12815141Quinones S, Bernal D, Garcia-Sogo M, Elena SF, Saus J. Exon/intron structure of the human alpha 3(IV) gene encompassing the Goodpasture antigen (alpha 3(IV)NC1). Identification of a potentially antigenic region at the triple helix/NC1 domain junction. J Biol Chem. 1992 Oct 5;267(28):19780-4.
PubMed 1400291Revert F, Penades JR, Plana M, Bernal D, Johansson C, Itarte E, Cervera J, Wieslander J, Quinones S, Saus J. Phosphorylation of the Goodpasture antigen by type A protein kinases. J Biol Chem. 1995 Jun 2;270(22):13254-61. doi: 10.1074/jbc.270.22.13254.
PubMed 7768924Borza CM, Borza DB, Pedchenko V, Saleem MA, Mathieson PW, Sado Y, Hudson HM, Pozzi A, Saus J, Abrahamson DR, Zent R, Hudson BG. Human podocytes adhere to the KRGDS motif of the alpha3alpha4alpha5 collagen IV network. J Am Soc Nephrol. 2008 Apr;19(4):677-84. doi: 10.1681/ASN.2007070793. Epub 2008 Jan 30.
PubMed 18235087Raya A, Revert-Ros F, Martinez-Martinez P, Navarro S, Rosello E, Vieites B, Granero F, Forteza J, Saus J. Goodpasture antigen-binding protein, the kinase that phosphorylates the goodpasture antigen, is an alternatively spliced variant implicated in autoimmune pathogenesis. J Biol Chem. 2000 Dec 22;275(51):40392-9. doi: 10.1074/jbc.M002769200.
PubMed 11007769Hanada K, Kumagai K, Yasuda S, Miura Y, Kawano M, Fukasawa M, Nishijima M. Molecular machinery for non-vesicular trafficking of ceramide. Nature. 2003 Dec 18;426(6968):803-9. doi: 10.1038/nature02188.
PubMed 14685229Revert F, Merino R, Monteagudo C, Macias J, Peydro A, Alcacer J, Muniesa P, Marquina R, Blanco M, Iglesias M, Revert-Ros F, Merino J, Saus J. Increased Goodpasture antigen-binding protein expression induces type IV collagen disorganization and deposit of immunoglobulin A in glomerular basement membrane. Am J Pathol. 2007 Nov;171(5):1419-30. doi: 10.2353/ajpath.2007.070205. Epub 2007 Oct 4.
PubMed 17916599Revert-Ros F, Lopez-Pascual E, Granero-Molto F, Macias J, Breyer R, Zent R, Hudson BG, Saadeddin A, Revert F, Blasco R, Navarro C, Burks D, Saus J. Goodpasture antigen-binding protein (GPBP) directs myofibril formation: identification of intracellular downstream effector 130-kDa GPBP-interacting protein (GIP130). J Biol Chem. 2011 Oct 7;286(40):35030-43. doi: 10.1074/jbc.M111.249458. Epub 2011 Aug 9.
PubMed 21832087Darris C, Revert F, Revert-Ros F, Gozalbo-Rovira R, Feigley A, Fidler A, Lopez-Pascual E, Saus J, Hudson BG. Unicellular ancestry and mechanisms of diversification of Goodpasture antigen-binding protein. J Biol Chem. 2019 Jan 18;294(3):759-769. doi: 10.1074/jbc.RA118.006225. Epub 2018 Oct 30.
PubMed 30377252Revert F, Revert-Ros F, Blasco R, Artigot A, Lopez-Pascual E, Gozalbo-Rovira R, Ventura I, Gutierrez-Carbonell E, Roda N, Ruiz-Sanchis D, Forteza J, Alcacer J, Perez-Sastre A, Diaz A, Perez-Paya E, Sanz-Cervera JF, Saus J. Selective targeting of collagen IV in the cancer cell microenvironment reduces tumor burden. Oncotarget. 2018 Jan 19;9(13):11020-11045. doi: 10.18632/oncotarget.24280. eCollection 2018 Feb 16.
PubMed 29541394
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Study for Efficacy and Safety of Metformin Glycinate for the Treatment of Patients With MS and DM2, Hospitalized With Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2. Randomized, Double-Blind, Phase IIIb.
- ClinicalTrials.gov ID
- NCT04626089
- Acronym / sponsor ID
- DMMETCOV19 / SIL-30000-II(1)
- Keywords
- SARS-CoV 2, Metabolic Syndrome, Type 2 diabetes, Severe Acute Respiratory Syndrome, Metformin glycinate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative decision of the company
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
- Study start
- Feb 2021 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 12 Nov 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.
The purpose of this study is to evaluate the efficacy and safety of metformin glycinate at dose of 620 mg twice per day plus standard treatment comparing to standard treatment alone (we will use placebo) of patients who have metabolic syndrome or type 2 diabetes, which have severe acute respiratory syndrome secondary to SARS-CoV-2.
Detailed description
After being informed about the study and potential risks, all patients will give written informed consent and undergo a 1 day screening period to determine the eligibility for study entry. At day 0, patients who meet the eligibility requirements will be randomized in a double blind (participant and investigator) in a 1:1 ratio to metformin glycinate (620 mg, taken orally twice daily) plus standard treatment or placebo (taken orally,twice daily) plus standard treatment, both will be for 14 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
- Model description
- Experimental group: Metformin glycinate 620 mg bid (PO) plus standard treatment for 14 days. Control Group: Placebo bid (PO) plus standard treatment for 14 days plus
| Arm | Type | Receives |
|---|---|---|
| Metformin glycinate | Experimental | Drug: metformin glycinate620 mg bid (PO) plus standard treatment for 14 days |
| Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo tablets bid (PO) plus standard treatment for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years old
- Ability to understand and the willingness to sign a written informed consent document before any study procedure
- Metabolic syndrome or type 2 diabetes
- Coronavirus infection, severe acute respiratory syndrome SARS-CoV- 2 confirmed by the Polymerase Chain Reaction test (PCR) ≤ 4 days before of the randomization.
- Hospitalized patient.
Key exclusion criteria (4 listed)
- Participation in any other clinical trial of an experimental treatment for COVID-19
- Evidence of multi-organ failure
- Require mechanical ventilation before randomization
- Pregnant patients
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 |
|---|---|---|
| metformin glycinateAlso: DMMETParticipants randomized to metformin glycinate wil take 620 mg bid (PO) plus standard treatment for 14 days | Drug | Metformin glycinate |
| Placebo oral tabletAlso: PlaceboParticipants randomized to placebo will take a tablet bid (PO) plus standard treatment for 14 days | Drug | Placebo |
Primary outcome
Viral Load
Time frame: Day 0 to Day 8 or patient discharge day
Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate
11 secondary outcomes
Days of supplementary oxygen if apply
Time frame: Day 0 to day 28 or patient discharge day
Days of supplementary mechanical ventilation if apply
Time frame: Day 0 to day 28 or patient discharge day
Days of Hospitalization
Time frame: Day 0 to day 28 or patients discharge day
Normalization of fever
Time frame: Day 0 to day 28 or patient discharge day
Normalization of oxigen saturation
Time frame: Day 0 to day 28 or patient discharge day
Number of deaths
Time frame: Day 0 to day 28 or patient discharge day
Change in Serum creatinine levels
Time frame: Day 0 to day 28 or patients discharge day
Change in serum Troponin I
Time frame: Day 0 to day 28 or patients discharge day
Change in serum aspartate aminotransferase levels
Time frame: Day 0 to day 28 or patients discharge day
Change in serum Creatine kinase-MB levels
Time frame: Day 0 to day 28 or patients discharge day
Incidence of adverse event
Time frame: Day 0 to day 28 or patients discharge day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Background: PubMed 18772132Revert F, Ventura I, Martinez-Martinez P, Granero-Molto F, Revert-Ros F, Macias J, Saus J. Goodpasture antigen-binding protein is a soluble exportable protein that interacts with type IV collagen. Identification of novel membrane-bound isoforms. J Biol Chem. 2008 Oct 31;283(44):30246-55. doi: 10.1074/jbc.M805026200. Epub 2008 Sep 4.
- BackgroundGlucophage Product Monograph (metformin hydrochloride) Sanofi-Aventis Canada. Rev.28th October 2008
- BackgroundNDA 20-357, Glucophage. US Food and Drug Administration. Center for Drug Evaluation and Research. Freedom of Information Office. New Drug Approval Packages. Pharmacology/Toxicology Review.
- BackgroundNDA 21-842, Actoplus met. US Food and Drug Administration. Center for Drug Evaluation and Research. Freedom of Information Office. New Drug Approval Packages. Pharmacology/Toxicology Review.
- Results publication: PubMed 3417661Saus J, Wieslander J, Langeveld JP, Quinones S, Hudson BG. Identification of the Goodpasture antigen as the alpha 3(IV) chain of collagen IV. J Biol Chem. 1988 Sep 15;263(26):13374-80.
- Results publication: PubMed 12815141Hudson BG, Tryggvason K, Sundaramoorthy M, Neilson EG. Alport's syndrome, Goodpasture's syndrome, and type IV collagen. N Engl J Med. 2003 Jun 19;348(25):2543-56. doi: 10.1056/NEJMra022296. No abstract available.
- Results publication: PubMed 1400291Quinones S, Bernal D, Garcia-Sogo M, Elena SF, Saus J. Exon/intron structure of the human alpha 3(IV) gene encompassing the Goodpasture antigen (alpha 3(IV)NC1). Identification of a potentially antigenic region at the triple helix/NC1 domain junction. J Biol Chem. 1992 Oct 5;267(28):19780-4.
- Results publication: PubMed 7768924Revert F, Penades JR, Plana M, Bernal D, Johansson C, Itarte E, Cervera J, Wieslander J, Quinones S, Saus J. Phosphorylation of the Goodpasture antigen by type A protein kinases. J Biol Chem. 1995 Jun 2;270(22):13254-61. doi: 10.1074/jbc.270.22.13254.
- Results publication: PubMed 18235087Borza CM, Borza DB, Pedchenko V, Saleem MA, Mathieson PW, Sado Y, Hudson HM, Pozzi A, Saus J, Abrahamson DR, Zent R, Hudson BG. Human podocytes adhere to the KRGDS motif of the alpha3alpha4alpha5 collagen IV network. J Am Soc Nephrol. 2008 Apr;19(4):677-84. doi: 10.1681/ASN.2007070793. Epub 2008 Jan 30.
- Results publication: PubMed 11007769Raya A, Revert-Ros F, Martinez-Martinez P, Navarro S, Rosello E, Vieites B, Granero F, Forteza J, Saus J. Goodpasture antigen-binding protein, the kinase that phosphorylates the goodpasture antigen, is an alternatively spliced variant implicated in autoimmune pathogenesis. J Biol Chem. 2000 Dec 22;275(51):40392-9. doi: 10.1074/jbc.M002769200.
- Results publication: PubMed 14685229Hanada K, Kumagai K, Yasuda S, Miura Y, Kawano M, Fukasawa M, Nishijima M. Molecular machinery for non-vesicular trafficking of ceramide. Nature. 2003 Dec 18;426(6968):803-9. doi: 10.1038/nature02188.
- Results publication: PubMed 17916599Revert F, Merino R, Monteagudo C, Macias J, Peydro A, Alcacer J, Muniesa P, Marquina R, Blanco M, Iglesias M, Revert-Ros F, Merino J, Saus J. Increased Goodpasture antigen-binding protein expression induces type IV collagen disorganization and deposit of immunoglobulin A in glomerular basement membrane. Am J Pathol. 2007 Nov;171(5):1419-30. doi: 10.2353/ajpath.2007.070205. Epub 2007 Oct 4.
- 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.
Fausto González-Villagrán, MD principal investigator
Hospital Juárez de México, OPD
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 metformin glycinate in people with Severe Acute Respiratory Syndrome Coronavirus 2 and Metabolic Syndrome, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.
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 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Apr 2021. 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 Mexico. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral Load (time frame: Day 0 to Day 8 or patient discharge day). 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 NCT04626089, which also lists 48 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 8 Apr 2021.