Covid19NCT04473352
COVID-19 Detection Tests in Different Body Fluids
An observational study of Covid19, run by Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara.
Trial summary
A clinical and experimental study will be carried out in which the clinician will investigate the PCR of the virus early in different body fluids (blood, semen, urine, saliva) and monitor its experimental clearance and evaluate in vitro diagnostic tests and inhibitory factors of viral proliferation. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Covid19
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Nov 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult male patients with suspected acute viral status for COVID 19 of the city of Fortaleza, Ceara, Brazil, who agreed to participate in the study.
Who may be able to join
- Subjects over the age of 18 years
- Agreement with the IC
Who cannot join
- History of previous prostate surgery or vasectomy
- Inability to assess participation in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diagnostic Accuracy of COVID-19 Detection Tests in Different Body Fluids of Infected Men and Concordance With Viral Cultures
A clinical and experimental study will be carried out in which the clinician will investigate the PCR of the virus early in different body fluids (blood, semen, urine, saliva) and monitor its experimental clearance and evaluate in vitro diagnostic tests and inhibitory factors of viral proliferation.
Read the detailed description
The World Health Organization (WHO) declared Coronavirus 2019 (COVID-19) as a pandemic on March 11, 2020. Due to the rapid spread of the severe acute respiratory syndrome coronavirus 2 virus (SARS-CoV-2), we are currently facing an unprecedented global situation. One of the main pillars in the control of an epidemic is the performance of large-scale tests providing a quick and accurate diagnosis so that the authorities can take timely action. Therefore, tests for COVID-19 should be prompt, widely available, and implemented outside the hospital environment, to avoid overloading the health system and decreasing the risks of hospital transmission to other patients and health professionals. Although universal testing is a cornerstone for reducing the burden of COVID-19, the accuracy of the commercially available tests for COVID-19 in Brazil remains uncertain. In addition, the natural history of the disease in the different organs and tissues is not unquestionably known, nor because the virus develops better in some tissues and not others. There are still many unanswered questions regarding COVID-19. allow more accurate knowledge of the natural history of the disease in the timeline taking into account the acute and long-term phases. Several families of viruses can affect the male genitourinary system, as is the case of the Zika (ZKV) and Ebola viruses. There are reports that in young patients infected with ZKV, the virus persists in semen for up to 6 months after the symptomatic condition. The other SARS-CoV-1 itself was detected in human testicles associated with an inflammatory process (orchiepididymitis), suggesting the possibility that these viruses could also be detected in the semen. As SARS-CoV-1 was able to overcome the hemato-gestural barrier and induce severe testicular damage in the previous outbreak, it is possible that men infected with COVID-19 may also have testicular damage. Another question that remains unanswered is whether the coronavirus can remain in the body of people considered recovered from Covid-19 for an indefinite period. It is also unknown whether there are molecules in the body fluids capable of inhibiting viral growth. The expected benefits are related to a better understanding of COVID's natural history19 and which body fluids can contribute to understanding the pathophysiology of the disease. It will be possible to identify the best time and the test with the best accuracy to diagnose the disease. It is our intention to identify substances in body fluids with an antiviral effect
- Conditions
- Covid19
- Keywords
- Covid, Body Fluids, Viral Cultures, Detection Tests
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Patients with suspected acute viral status for COVID 19 will be invited to participate in the identification of the first symptoms. The diagnosis of COVID-19 will be confirmed according to the determinations of the MS through the reaction of qRT-PCR in the nasopharynx swab. Patients will undergo multiple collections of biological material including blood, saliva, semen, and urine. Each patient will be subjected to serial sample collections. The samples will be processed and analyzed for the presence of viral RNA. Patients with 2 consecutive negative samples did not need to perform subsequent collections. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Covid19 Detection
Numerical variables will be described by measurements of central tendency (mean or median) and the respective dispersion measurements. Categorical variables will be described by their absolute values, percentages, or proportions. To compare the differences of continuous variables, we will use the Student t-test or the Mann-Whitney test. For comparison of categorical data, we will use the chi-square test. Univariable and multivariable analyses will be performed to identify predictors of COVID-19 detection.
Measured: September 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study startSep 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal do Ceara
- Responsible party
- Principal investigator, Ricardo Reges Maia de Oliveira, Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
- Investigators
- Ricardo Reges, PhD, Principal investigator, Nucleo de Pesquisa e Desenvolvimento de Medicamentos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473352
- Sponsor's protocol ID
- COVID Fluids
- Status last verified
- Aug 2020
- First submitted
- 18 Jun 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koh D, Cunningham AC. Counting Coronavirus Disease 2019 (COVID-19) Cases: Case Definitions, Screened Populations and Testing Techniques Matter. Ann Acad Med Singap. 2020 Mar;49(3):161-165.
PubMed 32301478Lin C, Xiang J, Yan M, Li H, Huang S, Shen C. Comparison of throat swabs and sputum specimens for viral nucleic acid detection in 52 cases of novel coronavirus (SARS-Cov-2)-infected pneumonia (COVID-19). Clin Chem Lab Med. 2020 Jun 25;58(7):1089-1094. doi: 10.1515/cclm-2020-0187.
PubMed 32301745Ling Y, Xu SB, Lin YX, Tian D, Zhu ZQ, Dai FH, Wu F, Song ZG, Huang W, Chen J, Hu BJ, Wang S, Mao EQ, Zhu L, Zhang WH, Lu HZ. Persistence and clearance of viral RNA in 2019 novel coronavirus disease rehabilitation patients. Chin Med J (Engl). 2020 May 5;133(9):1039-1043. doi: 10.1097/CM9.0000000000000774.
PubMed 32118639Lippi G, Simundic AM, Plebani M. Potential preanalytical and analytical vulnerabilities in the laboratory diagnosis of coronavirus disease 2019 (COVID-19). Clin Chem Lab Med. 2020 Jun 25;58(7):1070-1076. doi: 10.1515/cclm-2020-0285.
PubMed 32172228Liu R, Ma Q, Han H, Su H, Liu F, Wu K, Wang W, Zhu C. The value of urine biochemical parameters in the prediction of the severity of coronavirus disease 2019. Clin Chem Lab Med. 2020 Jun 25;58(7):1121-1124. doi: 10.1515/cclm-2020-0220.
PubMed 32286242Mardani R, Ahmadi Vasmehjani A, Zali F, Gholami A, Mousavi Nasab SD, Kaghazian H, Kaviani M, Ahmadi N. Laboratory Parameters in Detection of COVID-19 Patients with Positive RT-PCR; a Diagnostic Accuracy Study. Arch Acad Emerg Med. 2020 Apr 4;8(1):e43. eCollection 2020.
PubMed 32259132Padoan A, Cosma C, Sciacovelli L, Faggian D, Plebani M. Analytical performances of a chemiluminescence immunoassay for SARS-CoV-2 IgM/IgG and antibody kinetics. Clin Chem Lab Med. 2020 Jun 25;58(7):1081-1088. doi: 10.1515/cclm-2020-0443.
PubMed 32301749Pan F, Xiao X, Guo J, Song Y, Li H, Patel DP, Spivak AM, Alukal JP, Zhang X, Xiong C, Li PS, Hotaling JM. No evidence of severe acute respiratory syndrome-coronavirus 2 in semen of males recovering from coronavirus disease 2019. Fertil Steril. 2020 Jun;113(6):1135-1139. doi: 10.1016/j.fertnstert.2020.04.024. Epub 2020 Apr 17.
PubMed 32482249Wang W, Xu Y, Gao R, Lu R, Han K, Wu G, Tan W. Detection of SARS-CoV-2 in Different Types of Clinical Specimens. JAMA. 2020 May 12;323(18):1843-1844. doi: 10.1001/jama.2020.3786.
PubMed 32159775Wolfel R, Corman VM, Guggemos W, Seilmaier M, Zange S, Muller MA, Niemeyer D, Jones TC, Vollmar P, Rothe C, Hoelscher M, Bleicker T, Brunink S, Schneider J, Ehmann R, Zwirglmaier K, Drosten C, Wendtner C. Virological assessment of hospitalized patients with COVID-2019. Nature. 2020 May;581(7809):465-469. doi: 10.1038/s41586-020-2196-x. Epub 2020 Apr 1.
PubMed 32235945Wu J, Liu J, Li S, Peng Z, Xiao Z, Wang X, Yan R, Luo J. Detection and analysis of nucleic acid in various biological samples of COVID-19 patients. Travel Med Infect Dis. 2020 Sep-Oct;37:101673. doi: 10.1016/j.tmaid.2020.101673. Epub 2020 Apr 18.
PubMed 32311437Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
PubMed 32091533Yu F, Yan L, Wang N, Yang S, Wang L, Tang Y, Gao G, Wang S, Ma C, Xie R, Wang F, Tan C, Zhu L, Guo Y, Zhang F. Quantitative Detection and Viral Load Analysis of SARS-CoV-2 in Infected Patients. Clin Infect Dis. 2020 Jul 28;71(15):793-798. doi: 10.1093/cid/ciaa345.
PubMed 32221523Castro R, Luz PM, Wakimoto MD, Veloso VG, Grinsztejn B, Perazzo H. COVID-19: a meta-analysis of diagnostic test accuracy of commercial assays registered in Brazil. Braz J Infect Dis. 2020 Mar-Apr;24(2):180-187. doi: 10.1016/j.bjid.2020.04.003. Epub 2020 Apr 18.
PubMed 32330437Chen Y, Chen L, Deng Q, Zhang G, Wu K, Ni L, Yang Y, Liu B, Wang W, Wei C, Yang J, Ye G, Cheng Z. The presence of SARS-CoV-2 RNA in the feces of COVID-19 patients. J Med Virol. 2020 Jul;92(7):833-840. doi: 10.1002/jmv.25825. Epub 2020 Apr 25.
PubMed 32243607
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of COVID-19 Detection Tests in Different Body Fluids of Infected Men and Concordance With Viral Cultures
- ClinicalTrials.gov ID
- NCT04473352
- Acronym / sponsor ID
- COVID Fluids
- Conditions
- Covid19
- Keywords
- Covid, Body Fluids, Viral Cultures, Detection Tests
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do CearaUniversity, hospital or other
- Collaborators
- Universidade Federal do Ceara
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 16 Jul 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.
A clinical and experimental study will be carried out in which the clinician will investigate the PCR of the virus early in different body fluids (blood, semen, urine, saliva) and monitor its experimental clearance and evaluate in vitro diagnostic tests and inhibitory factors of viral proliferation.
Detailed description
The World Health Organization (WHO) declared Coronavirus 2019 (COVID-19) as a pandemic on March 11, 2020. Due to the rapid spread of the severe acute respiratory syndrome coronavirus 2 virus (SARS-CoV-2), we are currently facing an unprecedented global situation. One of the main pillars in the control of an epidemic is the performance of large-scale tests providing a quick and accurate diagnosis so that the authorities can take timely action. Therefore, tests for COVID-19 should be prompt, widely available, and implemented outside the hospital environment, to avoid overloading the health system and decreasing the risks of hospital transmission to other patients and health professionals. Although universal testing is a cornerstone for reducing the burden of COVID-19, the accuracy of the commercially available tests for COVID-19 in Brazil remains uncertain. In addition, the natural history of the disease in the different organs and tissues is not unquestionably known, nor because the virus develops better in some tissues and not others. There are still many unanswered questions regarding COVID-19. allow more accurate knowledge of the natural history of the disease in the timeline taking into account the acute and long-term phases. Several families of viruses can affect the male genitourinary system, as is the case of the Zika (ZKV) and Ebola viruses. There are reports that in young patients infected with ZKV, the virus persists in semen for up to 6 months after the symptomatic condition. The other SARS-CoV-1 itself was detected in human testicles associated with an inflammatory process (orchiepididymitis), suggesting the possibility that these viruses could also be detected in the semen. As SARS-CoV-1 was able to overcome the hemato-gestural barrier and induce severe testicular damage in the previous outbreak, it is possible that men infected with COVID-19 may also have testicular damage. Another question that remains unanswered is whether the coronavirus can remain in the body of people considered recovered from Covid-19 for an indefinite period. It is also unknown whether there are molecules in the body fluids capable of inhibiting viral growth. The expected benefits are related to a better understanding of COVID's natural history19 and which body fluids can contribute to understanding the pathophysiology of the disease. It will be possible to identify the best time and the test with the best accuracy to diagnose the disease. It is our intention to identify substances in body fluids with an antiviral effect
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | – | –Patients with suspected acute viral status for COVID 19 will be invited to participate in the identification of the first symptoms. The diagnosis of COVID-19 will be confirmed according to the determinations of the MS through the reaction of qRT-PCR in the nasopharynx swab. Patients will undergo multiple collections of biological material including blood, saliva, semen, and urine. Each patient will be subjected to serial sample collections. The samples will be processed and analyzed for the presence of viral RNA. Patients with 2 consecutive negative samples did not need to perform subsequent collections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male patients with suspected acute viral status for COVID 19 of the city of Fortaleza, Ceara, Brazil, who agreed to participate in the study.
Key inclusion criteria (2 listed)
- Subjects over the age of 18 years
- Agreement with the IC
Key exclusion criteria (2 listed)
- History of previous prostate surgery or vasectomy
- Inability to assess participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of Covid19 Detection
Time frame: September 2021
Numerical variables will be described by measurements of central tendency (mean or median) and the respective dispersion measurements. Categorical variables will be described by their absolute values, percentages, or proportions. To compare the differences of continuous variables, we will use the Student t-test or the Mann-Whitney test. For comparison of categorical data, we will use the chi-square test. Univariable and multivariable analyses will be performed to identify predictors of COVID-19 detection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Background: PubMed 32301478Koh D, Cunningham AC. Counting Coronavirus Disease 2019 (COVID-19) Cases: Case Definitions, Screened Populations and Testing Techniques Matter. Ann Acad Med Singap. 2020 Mar;49(3):161-165.
- Background: PubMed 32301745Lin C, Xiang J, Yan M, Li H, Huang S, Shen C. Comparison of throat swabs and sputum specimens for viral nucleic acid detection in 52 cases of novel coronavirus (SARS-Cov-2)-infected pneumonia (COVID-19). Clin Chem Lab Med. 2020 Jun 25;58(7):1089-1094. doi: 10.1515/cclm-2020-0187.
- Background: PubMed 32118639Ling Y, Xu SB, Lin YX, Tian D, Zhu ZQ, Dai FH, Wu F, Song ZG, Huang W, Chen J, Hu BJ, Wang S, Mao EQ, Zhu L, Zhang WH, Lu HZ. Persistence and clearance of viral RNA in 2019 novel coronavirus disease rehabilitation patients. Chin Med J (Engl). 2020 May 5;133(9):1039-1043. doi: 10.1097/CM9.0000000000000774.
- Background: PubMed 32172228Lippi G, Simundic AM, Plebani M. Potential preanalytical and analytical vulnerabilities in the laboratory diagnosis of coronavirus disease 2019 (COVID-19). Clin Chem Lab Med. 2020 Jun 25;58(7):1070-1076. doi: 10.1515/cclm-2020-0285.
- Background: PubMed 32286242Liu R, Ma Q, Han H, Su H, Liu F, Wu K, Wang W, Zhu C. The value of urine biochemical parameters in the prediction of the severity of coronavirus disease 2019. Clin Chem Lab Med. 2020 Jun 25;58(7):1121-1124. doi: 10.1515/cclm-2020-0220.
- Background: PubMed 32259132Mardani R, Ahmadi Vasmehjani A, Zali F, Gholami A, Mousavi Nasab SD, Kaghazian H, Kaviani M, Ahmadi N. Laboratory Parameters in Detection of COVID-19 Patients with Positive RT-PCR; a Diagnostic Accuracy Study. Arch Acad Emerg Med. 2020 Apr 4;8(1):e43. eCollection 2020.
- Background: PubMed 32301749Padoan A, Cosma C, Sciacovelli L, Faggian D, Plebani M. Analytical performances of a chemiluminescence immunoassay for SARS-CoV-2 IgM/IgG and antibody kinetics. Clin Chem Lab Med. 2020 Jun 25;58(7):1081-1088. doi: 10.1515/cclm-2020-0443.
- Background: PubMed 32482249Pan F, Xiao X, Guo J, Song Y, Li H, Patel DP, Spivak AM, Alukal JP, Zhang X, Xiong C, Li PS, Hotaling JM. No evidence of severe acute respiratory syndrome-coronavirus 2 in semen of males recovering from coronavirus disease 2019. Fertil Steril. 2020 Jun;113(6):1135-1139. doi: 10.1016/j.fertnstert.2020.04.024. Epub 2020 Apr 17.
- Background: PubMed 32159775Wang W, Xu Y, Gao R, Lu R, Han K, Wu G, Tan W. Detection of SARS-CoV-2 in Different Types of Clinical Specimens. JAMA. 2020 May 12;323(18):1843-1844. doi: 10.1001/jama.2020.3786.
- Background: PubMed 32235945Wolfel R, Corman VM, Guggemos W, Seilmaier M, Zange S, Muller MA, Niemeyer D, Jones TC, Vollmar P, Rothe C, Hoelscher M, Bleicker T, Brunink S, Schneider J, Ehmann R, Zwirglmaier K, Drosten C, Wendtner C. Virological assessment of hospitalized patients with COVID-2019. Nature. 2020 May;581(7809):465-469. doi: 10.1038/s41586-020-2196-x. Epub 2020 Apr 1.
- Background: PubMed 32311437Wu J, Liu J, Li S, Peng Z, Xiao Z, Wang X, Yan R, Luo J. Detection and analysis of nucleic acid in various biological samples of COVID-19 patients. Travel Med Infect Dis. 2020 Sep-Oct;37:101673. doi: 10.1016/j.tmaid.2020.101673. Epub 2020 Apr 18.
- Background: PubMed 32091533Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Not yet recruitingPhase 3
Dapagliflozin for Long COVID Syndrome
COVID - 19, Long COVID Syndrome
RecruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruitingObservational study
Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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.
Ricardo Reges, PhD principal investigator
Nucleo de Pesquisa e Desenvolvimento de Medicamentos
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricardo Reges, PhD (+55 85 996479789, ricardoreges@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Covid19 Detection (time frame: September 2021). 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 NCT04473352, which also lists 16 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 13 Aug 2020.