COVID-19 InfectionNCT04458519
Efficacy of Intranasal Probiotic Treatment to Reduce Severity of Symptoms in COVID19 Infection
A study testing Probiorinse and Saline solution in people with COVID-19 Infection, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Randomised, single-blinded trial. Patients with a diagnosis of COVID-19 infection within the past 96 hours and not requiring hospitalization will be recruited into a trial of BID Nasal irrigation for 14 days, followed by a 14 day observation period. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- Probiorinse and Saline solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jul 2020to 27 May 2021
- Phase
- Interventional
- 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 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females aged 18-59 years
- Positive diagnosis of COVID-19 infection less than 96 hours
- Characteristic respiratory symptoms present but no more than mild to moderate
- No need for oxygen
- Temperature less than 38.0 ºC
- Not presently being considered for hospitalisation or ICU admission
Show all 9Show fewer
- Able to perform nasal irrigation
- Able to provide consent
- Able to communicate with the study team by phone, text or email
Who cannot join
- Patients with pre-existing conditions or demographic features placing them at increased risk of complications from COVID10 infection will not be included in this study. These will be considered exclusion factors, thus individuals will be questioned as to the presence or these factors during their telephone screening.
- Respiratory disorders:
- Asthma, Pre-existing COPD, bronchiectasis or cystic fibrosis
- Hypertension
- Cardiovascular disease:
- Rhythm disturbances, recent (less than 6 months), angina pectoris cardiac insufficiency
Show all 15Show fewer
- Diabetes
- Immunosuppressed patients (other than COVID-19 induced)
- Primary immune deficiencies such as hypogammaglobulinemia or common variable immune deficiency (CVID)
- Chemotherapy depressing the immune system
- Immune suppressing medications such as prednisone, Imuran, or TNF inhibitors, or anti-rejection transplant drugs.
- Solid organ transplant
- Cancer under treatment or within five years (except basocellular skin cancers)
- Pregnant or breastfeeding women or women unwilling to practice contraception as outlined in the study protocol for the duration of the study period.
- Allergy to milk or its derivatives
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 1P1
About this study
Official title: Randomised Single Blinded Clinical Study of Efficacy of Intranasal Probiotic Treatment to Reduce Severity of Symptoms in COVID19 Infection
Randomised, single-blinded trial. Patients with a diagnosis of COVID-19 infection within the past 96 hours and not requiring hospitalization will be recruited into a trial of BID Nasal irrigation for 14 days, followed by a 14 day observation period. Irrigation will be performed with either Probiorinse probiotic nasal irrigation solution or NeilMed Sinus rinse. Patients will be able to identify their treatments, but study staff will be blinded as to assignment.
Read the detailed description
BACKGROUND/OBJECTIVE
The potential role of the microbiome in COVID-19 disease remains little explored, yert may offer an unique therapeutic opportunity for its treatment. Airway inflammation and microbiome dysbiosis is present in COVID-19 patients and is related to evolution. The limited information on airway inflammation in COVID-19 suggests greater inflammation, as assessed by serum markers of inflammation, is associated by more severe disease. Late cell-mediated T-cell activation is paradoxically accompanied by TLR expression downregulation, which contributes to dysfunctional immune regulation. Individual predisposition to heightened inflammatory responses may contribute to this.
The investigators believe this early TLR downregulation is an important feature of the disease, allowing the disease to reproduce unchecked and spread during a prolonged asymptomatic shedding period.
Immune-evasion strategies are common to several viral infections such as influenza, respiratory syncytial virus, and human rhinovirus, COVID-19 may exploit this as well.
Lung microbiome data in COVID-19 is limited, but a small dataset of 8 hospitalised cases has been reported from China suggests pulmonary inflammation can be influenced by the microbiome at the time of intubation, arguing the need for a more favorable upper airway microbiome.
Based on the above information, the investigators believe that administration of probiotic bacteria directly to the upper airway via irrigation to patients receiving a diagnosis of COVID-19 will improve the status of the upper airway microbiome and reduce symptom severity and disease in patients with COVID-19 disease not requiring ICU admission or intubation.
The investigators believe intranasally applied 'health-inducing' bacteria will favorably modulate the response to COVID-19 infection, reducing its severity and complications. Probiorinse may exert potentially beneficial effects in COVID-19 infection via two potential and distinct mechanisms:
- Activation of the innate immune system via enhanced TLR signalling:
- Abundant TLR ligands present on the probiotic bacterial capsule may counter the downregulation in TLR expression and function seen with COVID-19 infection.
- Promotion of a 'healthy' microbiome profile in the nasopharynx:
- Reducing "seeding" the lower respiratory tract with inappropriate bacteria or pathogens.
- Conditioning inappropriate or excessive immune responses of the airway
The purpose of this clinical trial is thus to compare the safety and validity of intranasal irrigation with Lactococcus lactis W136 with saline nasal irrigation alone in patients with mild COVID-19 infection.
METHODOLOGY
Consent process in the current context of the COVID-19 pandemic: Verbal consent and confirmation of consent in writing or electronically.
Participants will be recruited via posted signs in the COVID-19 clinic and hospital Intranet advertising a research project for individuals diagnosed with COVID-19 infection.
This study will include three (3) periods, which will take the form of telephone calls / email contacts:
- Eligibility determination period (Day 0)
- Treatment period (Day 1 to Day 14): Probiorinse or Saline solution
- Follow-up period (Day 21 and Day 28)
STATISTICAL ANALYSIS
Analysis population:
The primary analysis population for the efficacy endpoints will be the randomized ITT population which includes all patients who have been allocated to a randomized treatment regardless of whether the treatment kit was used or not. The efficacy analyses will be conducted according to the treatment to which they were randomized.
The analysis population for safety endpoints is defined as all patients exposed to study medication, regardless of the amount of treatment administered. The safety analyses will be conducted according to the treatment patients actually received. The treatment emergent period is defined as the time from the first administration of study medication to Day 14 of post treatment period.
Data Analysis:
The following null hypothesis and alternative will be tested for the Probiorinse arm against NeilMed Sinus Rinse:
- H0: No treatment difference between Probiorinse and NeilMed Sinus Rinse.
- H1: There is a treatment difference between Probiorinse and NeilMed Sinus Rinse
Descriptive statistics including number of subjects mean, standard error, and least squares (LS) means will be provided. In addition, difference in LS means and the corresponding 95% confidence intervals (CI) will be provided along with the p-values.
- Conditions
- COVID-19 Infection
- Being tested
- Probiorinse, Saline solution
- Keywords
- COVID-19, Nasal irrigation, Probiotic, Microbiome, Lactococcus lactis W136
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbiorinseOther
Also called Natural health products, Probiotic
Nasal irrigations with probiotic twice-daily for a period of fourteen days
Saline solutionOther
Also called Natural health product
Nasal irrigations with saline-only twice-daily for a period of fourteen days
| Study group | Role | What they receive |
|---|---|---|
| Probiorinse | Experimental | Nasal irrigations with Probiorinse (2.4 Billion CFU (Colony-Forming Units) of Lactococcus Lactis W136, (NPN: 80085895)) twice-daily for a period of fourteen days Receives: Other: Probiorinse |
| Saline solution | Active comparator | Nasal irrigations with saline (NeilMed Sinus Rinse, (NPN: 80027142)) twice-daily for a period of fourteen days Receives: Other: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in severity of COVID-19 infection
Change in severity of COVID-19 infection as assessed by number of days with any symptoms of COVID-19 infection greater than or equal to 35 as measured on VAS scale as assessed at the 28 day endpoint.
Measured: 4 weeks
Secondary outcomes (3)
Number of days with any symptom of anosmia
Number of days with any symptom of anosmia
Measured: 4 weeks
Maximal intensity attained in overall assessment of symptoms of COVID-19 infection as measured on Visual Analogue Scale (VAS).
Maximal intensity attained in overall assessment of symptoms of COVID-19 infection as measured on Visual Analogue Scale (VAS). VAS scale from 0 to 100, with a higher score indicating a worse outcome.
Measured: 4 weeks
Number of days where rescue medication is required
Number of days where rescue medication is required
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start16 Jul 2020
- Primary completion27 May 2021
- Study completion27 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blinded, randomized, prospective trial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Y Desrosiers, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458519
- Sponsor's protocol ID
- PROBCO
- Other IDs
- 249512
- Status last verified
- Jul 2020
- First submitted
- 1 Jul 2020
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu J, Li S, Liu J, Liang B, Wang X, Wang H, Li W, Tong Q, Yi J, Zhao L, Xiong L, Guo C, Tian J, Luo J, Yao J, Pang R, Shen H, Peng C, Liu T, Zhang Q, Wu J, Xu L, Lu S, Wang B, Weng Z, Han C, Zhu H, Zhou R, Zhou H, Chen X, Ye P, Zhu B, Wang L, Zhou W, He S, He Y, Jie S, Wei P, Zhang J, Lu Y, Wang W, Zhang L, Li L, Zhou F, Wang J, Dittmer U, Lu M, Hu Y, Yang D, Zheng X. Longitudinal characteristics of lymphocyte responses and cytokine profiles in the peripheral blood of SARS-CoV-2 infected patients. EBioMedicine. 2020 May;55:102763. doi: 10.1016/j.ebiom.2020.102763. Epub 2020 Apr 18.
PubMed 32361250Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.
PubMed 32192578Liu Y, Yan LM, Wan L, Xiang TX, Le A, Liu JM, Peiris M, Poon LLM, Zhang W. Viral dynamics in mild and severe cases of COVID-19. Lancet Infect Dis. 2020 Jun;20(6):656-657. doi: 10.1016/S1473-3099(20)30232-2. Epub 2020 Mar 19. No abstract available.
PubMed 32199493Shen Z, Xiao Y, Kang L, Ma W, Shi L, Zhang L, Zhou Z, Yang J, Zhong J, Yang D, Guo L, Zhang G, Li H, Xu Y, Chen M, Gao Z, Wang J, Ren L, Li M. Genomic Diversity of Severe Acute Respiratory Syndrome-Coronavirus 2 in Patients With Coronavirus Disease 2019. Clin Infect Dis. 2020 Jul 28;71(15):713-720. doi: 10.1093/cid/ciaa203.
PubMed 32129843
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Single Blinded Clinical Study of Efficacy of Intranasal Probiotic Treatment to Reduce Severity of Symptoms in COVID19 Infection
- ClinicalTrials.gov ID
- NCT04458519
- Acronym / sponsor ID
- PROBCO
- Conditions
- COVID-19 Infection
- Keywords
- COVID-19, Nasal irrigation, Probiotic, Microbiome, Lactococcus lactis W136
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 7 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.
Randomised, single-blinded trial. Patients with a diagnosis of COVID-19 infection within the past 96 hours and not requiring hospitalization will be recruited into a trial of BID Nasal irrigation for 14 days, followed by a 14 day observation period. Irrigation will be performed with either Probiorinse probiotic nasal irrigation solution or NeilMed Sinus rinse. Patients will be able to identify their treatments, but study staff will be blinded as to assignment.
Detailed description
BACKGROUND/OBJECTIVE
The potential role of the microbiome in COVID-19 disease remains little explored, yert may offer an unique therapeutic opportunity for its treatment. Airway inflammation and microbiome dysbiosis is present in COVID-19 patients and is related to evolution. The limited information on airway inflammation in COVID-19 suggests greater inflammation, as assessed by serum markers of inflammation, is associated by more severe disease. Late cell-mediated T-cell activation is paradoxically accompanied by TLR expression downregulation, which contributes to dysfunctional immune regulation. Individual predisposition to heightened inflammatory responses may contribute to this.
The investigators believe this early TLR downregulation is an important feature of the disease, allowing the disease to reproduce unchecked and spread during a prolonged asymptomatic shedding period.
Immune-evasion strategies are common to several viral infections such as influenza, respiratory syncytial virus, and human rhinovirus, COVID-19 may exploit this as well.
Lung microbiome data in COVID-19 is limited, but a small dataset of 8 hospitalised cases has been reported from China suggests pulmonary inflammation can be influenced by the microbiome at the time of intubation, arguing the need for a more favorable upper airway microbiome.
Based on the above information, the investigators believe that administration of probiotic bacteria directly to the upper airway via irrigation to patients receiving a diagnosis of COVID-19 will improve the status of the upper airway microbiome and reduce symptom severity and disease in patients with COVID-19 disease not requiring ICU admission or intubation.
The investigators believe intranasally applied 'health-inducing' bacteria will favorably modulate the response to COVID-19 infection, reducing its severity and complications. Probiorinse may exert potentially beneficial effects in COVID-19 infection via two potential and distinct mechanisms:
- Activation of the innate immune system via enhanced TLR signalling:
- Abundant TLR ligands present on the probiotic bacterial capsule may counter the downregulation in TLR expression and function seen with COVID-19 infection.
- Promotion of a 'healthy' microbiome profile in the nasopharynx:
- Reducing "seeding" the lower respiratory tract with inappropriate bacteria or pathogens.
- Conditioning inappropriate or excessive immune responses of the airway
The purpose of this clinical trial is thus to compare the safety and validity of intranasal irrigation with Lactococcus lactis W136 with saline nasal irrigation alone in patients with mild COVID-19 infection.
METHODOLOGY
Consent process in the current context of the COVID-19 pandemic: Verbal consent and confirmation of consent in writing or electronically.
Participants will be recruited via posted signs in the COVID-19 clinic and hospital Intranet advertising a research project for individuals diagnosed with COVID-19 infection.
This study will include three (3) periods, which will take the form of telephone calls / email contacts:
- Eligibility determination period (Day 0)
- Treatment period (Day 1 to Day 14): Probiorinse or Saline solution
- Follow-up period (Day 21 and Day 28)
STATISTICAL ANALYSIS
Analysis population:
The primary analysis population for the efficacy endpoints will be the randomized ITT population which includes all patients who have been allocated to a randomized treatment regardless of whether the treatment kit was used or not. The efficacy analyses will be conducted according to the treatment to which they were randomized.
The analysis population for safety endpoints is defined as all patients exposed to study medication, regardless of the amount of treatment administered. The safety analyses will be conducted according to the treatment patients actually received. The treatment emergent period is defined as the time from the first administration of study medication to Day 14 of post treatment period.
Data Analysis:
The following null hypothesis and alternative will be tested for the Probiorinse arm against NeilMed Sinus Rinse:
- H0: No treatment difference between Probiorinse and NeilMed Sinus Rinse.
- H1: There is a treatment difference between Probiorinse and NeilMed Sinus Rinse
Descriptive statistics including number of subjects mean, standard error, and least squares (LS) means will be provided. In addition, difference in LS means and the corresponding 95% confidence intervals (CI) will be provided along with the p-values.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blinded, randomized, prospective trial
| Arm | Type | Receives |
|---|---|---|
| Probiorinse | Experimental | Other: ProbiorinseNasal irrigations with Probiorinse (2.4 Billion CFU (Colony-Forming Units) of Lactococcus Lactis W136, (NPN: 80085895)) twice-daily for a period of fourteen days |
| Saline solution | Active comparator | Other: Saline solutionNasal irrigations with saline (NeilMed Sinus Rinse, (NPN: 80027142)) twice-daily for a period of fourteen days |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Males and females aged 18-59 years
- Positive diagnosis of COVID-19 infection less than 96 hours
- Characteristic respiratory symptoms present but no more than mild to moderate
- No need for oxygen
- Temperature less than 38.0 ºC
Key exclusion criteria (15 listed)
- Patients with pre-existing conditions or demographic features placing them at increased risk of complications from COVID10 infection will not be included in this study. These will be considered exclusion factors, thus individuals will be questioned as to the presence or these factors during their telephone screening.
- Respiratory disorders:
- Hypertension
- Cardiovascular disease:
- Diabetes
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 |
|---|---|---|
| ProbiorinseAlso: Natural health products, ProbioticNasal irrigations with probiotic twice-daily for a period of fourteen days | Other | Probiorinse |
| Saline solutionAlso: Natural health productNasal irrigations with saline-only twice-daily for a period of fourteen days | Other | Saline solution |
Primary outcome
Change in severity of COVID-19 infection
Time frame: 4 weeks
Change in severity of COVID-19 infection as assessed by number of days with any symptoms of COVID-19 infection greater than or equal to 35 as measured on VAS scale as assessed at the 28 day endpoint.
3 secondary outcomes
Number of days with any symptom of anosmia
Time frame: 4 weeks
Maximal intensity attained in overall assessment of symptoms of COVID-19 infection as measured on Visual Analogue Scale (VAS).
Time frame: 4 weeks
Number of days where rescue medication is required
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Background: PubMed 32361250Liu J, Li S, Liu J, Liang B, Wang X, Wang H, Li W, Tong Q, Yi J, Zhao L, Xiong L, Guo C, Tian J, Luo J, Yao J, Pang R, Shen H, Peng C, Liu T, Zhang Q, Wu J, Xu L, Lu S, Wang B, Weng Z, Han C, Zhu H, Zhou R, Zhou H, Chen X, Ye P, Zhu B, Wang L, Zhou W, He S, He Y, Jie S, Wei P, Zhang J, Lu Y, Wang W, Zhang L, Li L, Zhou F, Wang J, Dittmer U, Lu M, Hu Y, Yang D, Zheng X. Longitudinal characteristics of lymphocyte responses and cytokine profiles in the peripheral blood of SARS-CoV-2 infected patients. EBioMedicine. 2020 May;55:102763. doi: 10.1016/j.ebiom.2020.102763. Epub 2020 Apr 18.
- Background: PubMed 32192578Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.
- Background: PubMed 32199493Liu Y, Yan LM, Wan L, Xiang TX, Le A, Liu JM, Peiris M, Poon LLM, Zhang W. Viral dynamics in mild and severe cases of COVID-19. Lancet Infect Dis. 2020 Jun;20(6):656-657. doi: 10.1016/S1473-3099(20)30232-2. Epub 2020 Mar 19. No abstract available.
- Background: PubMed 32129843Shen Z, Xiao Y, Kang L, Ma W, Shi L, Zhang L, Zhou Z, Yang J, Zhong J, Yang D, Guo L, Zhang G, Li H, Xu Y, Chen M, Gao Z, Wang J, Ren L, Li M. Genomic Diversity of Severe Acute Respiratory Syndrome-Coronavirus 2 in Patients With Coronavirus Disease 2019. Clin Infect Dis. 2020 Jul 28;71(15):713-720. doi: 10.1093/cid/ciaa203.
- Study publication (Pre-print)Link provided by the sponsor.
- 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.
Martin Y Desrosiers, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiorinse and Saline solution in people with COVID-19 Infection, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 9 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 1 Jun 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in severity of COVID-19 infection (time frame: 4 weeks). 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 NCT04458519, which also lists 4 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 1 Jun 2021.