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Viral InfectionsNCT05336851

Emergency PWAS in Respiratory Infectious Disease

An observational study of Viral Infections and Bacterial Infections, run by The University of Hong Kong at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Develop an emergency PanorOmics Wide Association Study (ePWAS) for the early, rapid biological and pathophysiological characterisation of known and novel Infectious Diseases in adult patients presenting to emergency departments with suspected, acute, community-acquired respiratory infectious disease (scaRID). Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
What is being tested?
Biomarker blood draw and saliva collection
How many people
2,000 participants
Where
1 siteChina
Study dates
11 Apr 2023to 1 May 2028
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

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 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Suspected, acute, community-acquired, respiratory, infectious disease presenting to emergency department with symptom onset <8 days and reported fever or chills or aural temperature >37.5°C

Who may be able to join

  • Patients eligible for enrolment include:
  • With reference to previous inclusion criteria are:
  • Adults ≥18 years of age; AND
  • Suspected, acute, community-acquired, respiratory, infectious disease (scaRID)*; AND
  • Informed consent.
  • Note: scaRID is defined according to ALL three criteria:
Show all 19Show fewer
  • Community acquired (not hospitalised for <28 days); AND
  • Acute infection (defined as symptom onset <8 days and any ONE of reported fever or chills or aural temperature >37.5°C or hypothermia or leucocytosis or leucopaenia or new altered mental status); AND
  • Probable respiratory infection - According to any ONE of:
  • new cough or new sputum production or
  • chest pain or
  • dyspnoea or
  • tachypnoea or
  • abnormal lung examination or
  • respiratory failure; or
  • physician's judgment (presenting with systemic or gastrointestinal symptoms).
  • Control subjects will be drawn from two groups:
  • The worried well - adult patients with a National Early Warning Score (NEWS) <3 and a temperature <37.5°C.
  • Relatives or accompanying friends with no acute illness.

Who cannot join

  • Refusal of consent;
  • Recent hospitalisation (<28 days);
  • Enrolled in another clinical trial
  • Cellulitis;
  • Skin or orthopaedic infections;
  • Urinary tract infection;
Show all 16Show fewer
  • Acute abdominal sepsis;
  • Sexual transmitted disease;
  • Human immunodeficiency virus (HIV) infection;
  • Immunocompromised/potential neutropenic fever;
  • Solid organ or haematopoietic stem-cell transplant within the previous 90 days;
  • Active graft-versus-host disease or bronchiolitis obliterans;
  • Severe traveller's disease requiring urgent hospitalisation and management including malaria, dengue, typhoid and other rickettsial diseases;
  • Stroke;
  • Toxidrome;
  • Non-organic acute psychosis.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Timothy H Rainer, MD contact

+852 39176846

thrainer@hku.hk

China1 site, 1 recruiting

  • Hong Kong University

    Hong Kong

    Timothy H Rainer, MD, 852 39176846, thrainer@hku.hk

    Recruiting

Other trials in China

About this study

Official title: Emergency PanorOmic Wide Association Study in Respiratory Infectious Disease (ePWAS-RID)

Develop an emergency PanorOmics Wide Association Study (ePWAS) for the early, rapid biological and pathophysiological characterisation of known and novel Infectious Diseases in adult patients presenting to emergency departments with suspected, acute, community-acquired respiratory infectious disease (scaRID).

Phase 1

  1. Develop an ED-ID biobank (named ePWAS-RID). Phase 2
  2. Targeted research for the discovery of novel diagnostics, prognostics and therapeutics
Read the detailed description

Introduction

Pandemic Preparedness

The COVID-19 pandemic has affected over 220 million people, claimed over 450 000 lives and invoked variable responses across the world. Delays in acquiring quality clinical and scientific material on the transmissibility, clinical nature, outcomes and lethality of novel and known infectious diseases (ID) translate into healthcare inefficiencies, societal and economic stress, and increased morbidity and mortality. Regions with greater success in the fight against COVID-19 were well prepared before the pandemic.

Pathogens

The pathogens most likely to cause annual epidemics and pandemics are respiratory viruses. In Asia, viral infections account for 30-40% of sepsis cases. Each year there are 100 million cases of viral community-acquired pneumonia (CAP) of which 60% progress to sepsis. These viruses cause host-mediated, inflammatory, immune responses which progresses through three phases: preliminary regulated inflammation; intermediate dysregulated proinflammation; and late dysregulated hypoinflammation.

Clinical Spectrum

RID is a heterogeneous population of patients. This complex spectrum of heterogeneity extends throughout the underlying molecular biology and pathophysiology from genome to phenome. It includes significant individual variation in regulated and dysregulated systemic inflammatory host responses to infection in the presence and absence of organ dysfunction. Critical illness from any ID involves both host susceptibility to the pathogen and host propensity to develop dysregulated inflammation and organ failure (e.g. pulmonary inflammation and/or acute kidney injury).

PanorOmics-Wide Association Studies

In the five years prior to the COVID-19 pandemic, the United Kingdom's Genetics Of Mortality In Critical Care (GenOMICC) study recruited patients with a spectrum of critical illness syndromes (e.g. influenza, sepsis, and emerging infections) to better understand host mechanisms that lead to life-threatening outcomes. As a result, the GenOMICC investigators, along with collaborators from Spain and Italy, were well placed to perform genomic-association studies on critically ill COVID-19 patients and to make recommendations for future studies.

An integrated panorOmics approach has the potential to uncover causal associations and linkages across the entire spectrum of host biology including genomics, epigenomics, transcriptomics, proteomics, metabolomics and lipidomics, through to clinical phenotype. However, panorOmics as a discipline faces the same challenges as Genome-wide association studies (GWAS), only more so. Although GWAS correlate genomic loci with complex signatures and traits, efficient detection is hindered by false positives, linkage disequilibrium, and high expense. True causal variations and real underlying associations require multiple filters if they are to be detected.

The investigators propose to develop an ED-based system of dynamic studies on blood and saliva samples taken from patients at an early stage of ID. Early stage refers to a process in the patient pathway that precedes most patient recruitment in other studies i.e. on wards or ICU. The two primary objectives are a) to develop an ED-ID biobank; and b) to undertake preliminary discovery and targeted research for the discovery of novel diagnostics, prognostics and therapeutics.

The investigators will define early multiOmics signatures of RID and identify relationships to known and novel ID. Few studies have been published on the integrated panorOmics of COVID-19, and few if any address the early phases of illness or differentiating features in comparison to other respiratory illnesses.

In disease stratified, case-control matched comparisons of adult patients with scaRID attending EDs, what panorOmic signatures differentiate low risk from high risk across a 30-day WHO-Clinical Progression Scale (WHO-CPS)?

For the purpose of this study, scaRID is defined as:

  1. A fever or a temperature >37.5°C; AND
  2. One or more relevant symptoms:
  • respiratory symptoms (e.g. cough, shortness of breath), OR
  • systemic symptoms (e.g. chills, rigors, myalgia), OR
  • gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea); AND
  1. No obvious alternative cause (see exclusion criteria).

PanorOmic associations will be derived from liquid biopsy samples, including whole blood, plasma, serum, white cell pellet, red cell effluent, salivary supernatant, and salivary cells. Liquid biopsy biomarkers include genomic, transcriptomic, proteomic, metabolomic, lipidomic and haematological contents.

Hypothesis The investigators hypothesise that in propensity-matched, adult patients with pathogen-specific and disease specific RID (e.g. SARS-CoV-2, Influenza A) there are significant differences in panorOmic signatures that delineate host susceptibility and host response for mild to severe disease.

Objectives

The purpose of this proposal is to develop an emergency PanorOmics Wide Association Study (ePWAS) biobank for the early, rapid biological and pathophysiological characterisation of scaRID. More specifically, in adult patients presenting to EDs with scaRID and within 10 days of symptom onset, we aim:

  1. To develop an ED-ePWAS-RID biobank of blood and saliva samples
  2. To use this databank for exploratory and targeted research in the search for diagnostic and prognostic markers and to understand underlying mechanisms of disease

The goals of the biobank and the ePWAS-RID repository are:

  • to develop the infrastructure for a sustainable ED-based biobank of blood and saliva samples matched to clinical phenotypes and critical outcomes.
  • to develop the repository according to international standards thereby minimising heterogeneity and rendering the material suitable for international research frameworks that aims to facilitate access to human biological materials.
  • to prepare a repository for preliminary discovery of novel diagnostic, prognostic, and therapeutic markers.
  • to facilitate targeted research on the pathogenesis of respiratory infections, host susceptibility, and host response.
  • to derive biomarker platforms of training set models for early RID detection, pathogen differentiation, monitoring, risk stratification and prognosis; and to validate those models using independent and external datasets.
Being tested
Biomarker blood draw and saliva collection
Keywords
Biobank, Diagnostics and Prognostics, Emergency Medicine, Multiomics and Panoromics, Respiratory Infectious Disease
Medical subject headings
Virus Diseases, Bacterial Infections, Mycoses, Coinfection, Mycobacterium Infections, Pneumonia, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biomarker blood draw and saliva collectionDiagnostic test

    Three peripheral 10 - 20mL blood sample (if available) Three 1 - 5mL salivary samples (if available)

Study groups in NCT05336851
Study groupRoleWhat they receive
Viral infectionViral infection subjects presenting within 8 days from symptom onset will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms; and if they agree
Receives: Diagnostic Test: Biomarker blood draw and saliva collection
Bacterial infectionBacterial infection subjects presenting within 8 days from symptom onset will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms; and if they agree, a further two samples at b) 24 hours +/- 6 hours from symptom onset (if available); and c) 48 hours +/- 6 hours from symptom onset (if available).
Receives: Diagnostic Test: Biomarker blood draw and saliva collection
Viral-Viral co-infectionViral-viral co-infection subjects presenting within 8 days from symptom onset will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms; and if they agree, a further two samples at b) 24 hours +/- 6 hours from symptom onset (if available); and c) 48 hours +/- 6 hours from symptom onset (if available).
Receives: Diagnostic Test: Biomarker blood draw and saliva collection
Bacterial-Viral co-infectionBacterial-Viral co-infection subjects presenting within 8 days from symptom onset will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms; and if they agree, a further two samples at b) 24 hours +/- 6 hours from symptom onset (if available); and c) 48 hours +/- 6 hours from symptom onset (if available).
Receives: Diagnostic Test: Biomarker blood draw and saliva collection
Fungal-Mycobacterium co-infectionBacterial-Viral co-infection subjects presenting within 8 days from symptom onset will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms; and if they agree, a further two samples at b) 24 hours +/- 6 hours from symptom onset (if available); and c) 48 hours +/- 6 hours from symptom onset (if available).
Receives: Diagnostic Test: Biomarker blood draw and saliva collection
Infection of uncertain originInfection of uncertain origin subjects presenting within 8 days from symptom onset will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms; and if they agree, a further two samples at b) 24 hours +/- 6 hours from symptom onset (if available); and c) 48 hours +/- 6 hours from symptom onset (if available).
Receives: Diagnostic Test: Biomarker blood draw and saliva collection
Control SubjectsControl group subjects, if they agree, will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms (if applicable); and if they agree, a further two samples at b) 24 hours +/- 6 hours from symptom onset (if applicable); and c) 48 hours +/- 6 hours from symptom onset (if applicable).
Receives: Diagnostic Test: Biomarker blood draw and saliva collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. WHO-CPS

    Differentiation of WHO-CPS >6 from WHO-CPS ≤6

    Measured: Up to 30 days

Secondary outcomes (2)

  1. Mortality

    Mortality is defined as all-cause, Binary: Yes or No

    Measured: Up to 30 days

  2. Mortality

    Mortality is defined as all-cause, Binary: Yes or No

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2022
  2. Study start11 Apr 2023
  3. Primary completion1 May 2028 (estimated)
  4. Study completion1 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT05336851
Sponsor's protocol ID
ePWAS-RID/Rainer/2021
Status last verified
May 2026
First submitted
13 Apr 2022
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sharfstein JM, Becker SJ, Mello MM. Diagnostic Testing for the Novel Coronavirus. JAMA. 2020 Apr 21;323(15):1437-1438. doi: 10.1001/jama.2020.3864. No abstract available.

    PubMed 32150622

  • Leung K, Wu JT, Liu D, Leung GM. First-wave COVID-19 transmissibility and severity in China outside Hubei after control measures, and second-wave scenario planning: a modelling impact assessment. Lancet. 2020 Apr 25;395(10233):1382-1393. doi: 10.1016/S0140-6736(20)30746-7. Epub 2020 Apr 8.

    PubMed 32277878

  • Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.

    PubMed 31995857

  • He X, Lau EHY, Wu P, Deng X, Wang J, Hao X, Lau YC, Wong JY, Guan Y, Tan X, Mo X, Chen Y, Liao B, Chen W, Hu F, Zhang Q, Zhong M, Wu Y, Zhao L, Zhang F, Cowling BJ, Li F, Leung GM. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med. 2020 May;26(5):672-675. doi: 10.1038/s41591-020-0869-5. Epub 2020 Apr 15.

    PubMed 32296168

  • Williamson EJ, Walker AJ, Bhaskaran K, Bacon S, Bates C, Morton CE, Curtis HJ, Mehrkar A, Evans D, Inglesby P, Cockburn J, McDonald HI, MacKenna B, Tomlinson L, Douglas IJ, Rentsch CT, Mathur R, Wong AYS, Grieve R, Harrison D, Forbes H, Schultze A, Croker R, Parry J, Hester F, Harper S, Perera R, Evans SJW, Smeeth L, Goldacre B. Factors associated with COVID-19-related death using OpenSAFELY. Nature. 2020 Aug;584(7821):430-436. doi: 10.1038/s41586-020-2521-4. Epub 2020 Jul 8.

    PubMed 32640463

  • Pairo-Castineira E, Clohisey S, Klaric L, Bretherick AD, Rawlik K, Pasko D, Walker S, Parkinson N, Fourman MH, Russell CD, Furniss J, Richmond A, Gountouna E, Wrobel N, Harrison D, Wang B, Wu Y, Meynert A, Griffiths F, Oosthuyzen W, Kousathanas A, Moutsianas L, Yang Z, Zhai R, Zheng C, Grimes G, Beale R, Millar J, Shih B, Keating S, Zechner M, Haley C, Porteous DJ, Hayward C, Yang J, Knight J, Summers C, Shankar-Hari M, Klenerman P, Turtle L, Ho A, Moore SC, Hinds C, Horby P, Nichol A, Maslove D, Ling L, McAuley D, Montgomery H, Walsh T, Pereira AC, Renieri A; GenOMICC Investigators; ISARIC4C Investigators; COVID-19 Human Genetics Initiative; 23andMe Investigators; BRACOVID Investigators; Gen-COVID Investigators; Shen X, Ponting CP, Fawkes A, Tenesa A, Caulfield M, Scott R, Rowan K, Murphy L, Openshaw PJM, Semple MG, Law A, Vitart V, Wilson JF, Baillie JK. Genetic mechanisms of critical illness in COVID-19. Nature. 2021 Mar;591(7848):92-98. doi: 10.1038/s41586-020-03065-y. Epub 2020 Dec 11.

    PubMed 33307546

  • Legido-Quigley H, Asgari N, Teo YY, Leung GM, Oshitani H, Fukuda K, Cook AR, Hsu LY, Shibuya K, Heymann D. Are high-performing health systems resilient against the COVID-19 epidemic? Lancet. 2020 Mar 14;395(10227):848-850. doi: 10.1016/S0140-6736(20)30551-1. Epub 2020 Mar 6. No abstract available.

    PubMed 32151326

  • Lam TT, Jia N, Zhang YW, Shum MH, Jiang JF, Zhu HC, Tong YG, Shi YX, Ni XB, Liao YS, Li WJ, Jiang BG, Wei W, Yuan TT, Zheng K, Cui XM, Li J, Pei GQ, Qiang X, Cheung WY, Li LF, Sun FF, Qin S, Huang JC, Leung GM, Holmes EC, Hu YL, Guan Y, Cao WC. Identifying SARS-CoV-2-related coronaviruses in Malayan pangolins. Nature. 2020 Jul;583(7815):282-285. doi: 10.1038/s41586-020-2169-0. Epub 2020 Mar 26.

    PubMed 32218527

  • Hung IF, Lung KC, Tso EY, Liu R, Chung TW, Chu MY, Ng YY, Lo J, Chan J, Tam AR, Shum HP, Chan V, Wu AK, Sin KM, Leung WS, Law WL, Lung DC, Sin S, Yeung P, Yip CC, Zhang RR, Fung AY, Yan EY, Leung KH, Ip JD, Chu AW, Chan WM, Ng AC, Lee R, Fung K, Yeung A, Wu TC, Chan JW, Yan WW, Chan WM, Chan JF, Lie AK, Tsang OT, Cheng VC, Que TL, Lau CS, Chan KH, To KK, Yuen KY. Triple combination of interferon beta-1b, lopinavir-ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, phase 2 trial. Lancet. 2020 May 30;395(10238):1695-1704. doi: 10.1016/S0140-6736(20)31042-4. Epub 2020 May 10.

    PubMed 32401715

  • Tsang KW, Ho PL, Ooi GC, Yee WK, Wang T, Chan-Yeung M, Lam WK, Seto WH, Yam LY, Cheung TM, Wong PC, Lam B, Ip MS, Chan J, Yuen KY, Lai KN. A cluster of cases of severe acute respiratory syndrome in Hong Kong. N Engl J Med. 2003 May 15;348(20):1977-85. doi: 10.1056/NEJMoa030666. Epub 2003 Mar 31.

    PubMed 12671062

  • Wai AKC, Wong CKH, Wong JYH, Xiong X, Chu OCK, Wong MS, Tsui MSH, Rainer TH. Changes in Emergency Department Visits, Diagnostic Groups, and 28-Day Mortality Associated With the COVID-19 Pandemic: A Territory-Wide, Retrospective, Cohort Study. Ann Emerg Med. 2022 Feb;79(2):148-157. doi: 10.1016/j.annemergmed.2021.09.424. Epub 2021 Sep 24.

    PubMed 34742591

  • Southeast Asia Infectious Disease Clinical Research Network. Causes and outcomes of sepsis in southeast Asia: a multinational multicentre cross-sectional study. Lancet Glob Health. 2017 Feb;5(2):e157-e167. doi: 10.1016/S2214-109X(17)30007-4.

    PubMed 28104185

  • Gu X, Zhou F, Wang Y, Fan G, Cao B. Respiratory viral sepsis: epidemiology, pathophysiology, diagnosis and treatment. Eur Respir Rev. 2020 Jul 21;29(157):200038. doi: 10.1183/16000617.0038-2020. Print 2020 Sep 30.

    PubMed 32699026

  • Davenport EE, Burnham KL, Radhakrishnan J, Humburg P, Hutton P, Mills TC, Rautanen A, Gordon AC, Garrard C, Hill AV, Hinds CJ, Knight JC. Genomic landscape of the individual host response and outcomes in sepsis: a prospective cohort study. Lancet Respir Med. 2016 Apr;4(4):259-71. doi: 10.1016/S2213-2600(16)00046-1. Epub 2016 Feb 23.

    PubMed 26917434

  • Su Y, Chen D, Yuan D, Lausted C, Choi J, Dai CL, Voillet V, Duvvuri VR, Scherler K, Troisch P, Baloni P, Qin G, Smith B, Kornilov SA, Rostomily C, Xu A, Li J, Dong S, Rothchild A, Zhou J, Murray K, Edmark R, Hong S, Heath JE, Earls J, Zhang R, Xie J, Li S, Roper R, Jones L, Zhou Y, Rowen L, Liu R, Mackay S, O'Mahony DS, Dale CR, Wallick JA, Algren HA, Zager MA; ISB-Swedish COVID19 Biobanking Unit; Wei W, Price ND, Huang S, Subramanian N, Wang K, Magis AT, Hadlock JJ, Hood L, Aderem A, Bluestone JA, Lanier LL, Greenberg PD, Gottardo R, Davis MM, Goldman JD, Heath JR. Multi-Omics Resolves a Sharp Disease-State Shift between Mild and Moderate COVID-19. Cell. 2020 Dec 10;183(6):1479-1495.e20. doi: 10.1016/j.cell.2020.10.037. Epub 2020 Oct 28.

    PubMed 33171100

Questions about this trial

What is this clinical trial studying?

An observational study of Viral Infections and Bacterial Infections, run by The University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Timothy H Rainer, MD (+852 39176846, thrainer@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WHO-CPS (time frame: Up to 30 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 NCT05336851, which also lists 35 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 12 May 2026.

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