COVID-19Phase 2/3NCT04894474

A Study to Test Whether BI 767551 Can Prevent COVID-19 in People Who Have Been Exposed to SARS-CoV-2

A Phase 2/3 study testing BI 767551 intravenous and BI 767551 inhalation in people with COVID-19, run by Boehringer Ingelheim.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This study is open to adults living with a person who has tested positive for the coronavirus SARS-CoV-2. People who do not have symptoms of COVID-19 can take part in this study. The study is done to find out whether a medicine called BI 767551 can prevent COVID-19. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: BI 767551 intravenous and BI 767551 inhalation
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: No sites listed yet
Study dates: 17 Jun 2021to 24 Jul 2022
Phase: Phase 2/3
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, males and females
Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Asymptomatic for Coronavirus Disease 2019 (COVID-19) at time of screening and at randomization
Household contact with exposure to an individual with a diagnosis of Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (i.e. exposure to the index case)
Randomization within 96 hours of collection of the index cases' positive SARS-CoV-2 diagnostic test sample (nucleic acid or antigen-based) from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (NP), or nasal swab, or saliva); based on test sample collection date, not the result date.
From screening and randomization, the trial participant anticipates living in the same household with the index case until protocol Day 29.
Women of childbearing potential (WOCBP)* and men able to father a child must be ready and able to use highly effective methods of birth control per International Council on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 24 months without an alternative medical cause.

Who cannot join

Body weight of less than 40 kg
Residents of skilled nursing facilities. Definition of skilled nursing facility: assisted living facility that typically provides daily nursing care, 24-hour supervision, three meals a day, and assistance with everyday activities.
History of laboratory confirmed SARS-CoV-2 infection (e.g. antigen or nucleic acid test)at any time before screening
Active respiratory or non-respiratory symptoms consistent with COVID-19, in the opinion of the investigator
History of respiratory or non-respiratory symptoms consistent with COVID-19, within the prior 6 months to screening, in the opinion of the investigator
Participant has lived with individuals who have had previous SARS-CoV-2 infection or currently lives with individuals who have SARS-CoV-2 infection, with the exception of the index case(s) who is defined as the first individual(s) known to be infected in the household

Show all 20Show fewer

Receipt of intravenous immunoglobulin within 12 weeks prior to Visit 2
Receipt of COVID-19 convalescent plasma treatment at any time prior to Visit 2
Receipt of any SARS-CoV-2 monoclonal antibody treatment at any time prior to Visit 2
Receipt of SARS-CoV-2 vaccine at any time prior to Visit 2
Receipt of an investigational product for COVID-19 within 5 half-lives prior to Visit 2
Receipt of systemic steroids (e.g. prednisone, dexamethasone) within 4 weeks prior to Visit 2 unless used for chronic condition
Subjects who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
Any co-morbidity requiring surgery within 7 days prior to study entry, or that is considered life threatening in the opinion of investigator within 30 days prior to randomization
Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study
Subjects not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the subject an unreliable trial participant)
Currently enrolled in any other type of medical research judged not to be compatible with this study
Known allergy/sensitivity or any hypersensitivity to any of the components used in the formulation of the interventions
Previous enrolment in this trial
Women who are pregnant, nursing, or who plan to become pregnant while in the trial

About this study

Official title: A Phase III Randomized, Double-blind, Placebo-controlled, Parallel-group, Group-sequential Study to Evaluate Efficacy, Safety and Tolerability of BI 767551 for Post-exposure Prevention of SARS-CoV-2 Infection in Household Contacts to a Confirmed SARS-CoV-2 Infected Individual

Participants are put into 3 groups randomly, which means by chance.

1 group gets BI 767551 via an inhaler and placebo as an infusion
1 group gets BI 767551 as an infusion and placebo via an inhaler
1 group gets placebo both via an inhaler and as an infusion

All participants get study medicine once at study start and after 1 week. Placebo inhaler and infusion look like BI 767551 inhaler and infusion but do not contain any medicine.

Participants are in the study for about 3 months. During this time, they visit the study site about 10 times. About 7 of the 10 visits can be done at the participant's home. Participants are regularly tested for the coronavirus SARS-CoV-2. The doctors check whether the participants have been infected with the coronavirus and whether they have symptoms. The results are compared between the treatment groups. The doctors check the health of the participants and note any health problems that could have been caused by BI 767551.

Conditions: COVID-19
Being tested: BI 767551 intravenous, BI 767551 inhalation, Placebo intravenous, Placebo inhalation
Medical subject headings: COVID-19

What participants receive

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

BI 767551 intravenousDrug
BI 767551 intravenous
BI 767551 inhalationDrug
BI 767551 inhalation
Placebo intravenousDrug
Placebo intravenous
Placebo inhalationDrug
Placebo inhalation

Study groups in NCT04894474
Study group	Role	What they receive
BI 767551 inhalation and placebo intravenous infusion	Experimental	Not described Receives: Drug: BI 767551 inhalation; Drug: Placebo intravenous
BI 767551 intravenous infusion and placebo inhalation	Experimental	Not described Receives: Drug: BI 767551 intravenous; Drug: Placebo inhalation
Placebo inhalation and placebo intravenous infusion	Placebo comparator	Not described Receives: Drug: Placebo intravenous; Drug: Placebo inhalation

What is being measured

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

The primary endpoint of this study is symptomatic SARS-CoV-2 infection (RT-qPCR confirmed based on NP swabs, with a score >= 2 on the WHO Clinical Progression Scale) (Cohort A only)
Cohort A: negative SARS-CoV-2 RT-qPCR* and serology test* at baseline.
*test result from day of dosing (baseline) will be retrospectively determined by the sponsor-provided central laboratory. The designation of Cohorts is used only for the analysis not randomization.
qPCR: Quantitative Reverse Transcription Polymerase chain reaction; WHO: World Health Organisation;
The 11-point WHO Clinical Progression Scale ranges from 0 to 10, with a higher score indicating a worsening of the symptoms.
Measured: up to 31 days

Secondary outcomes (10)

SARS-CoV-2 infection, with or without symptoms (Cohort A only)
Cohort A: negative SARS-CoV-2 RT-qPCR* and serology test* at baseline.
*test result from day of dosing (baseline) will be retrospectively determined by the sponsor-provided central laboratory. The designation of Cohorts is used only for the analysis not randomization.
Measured: up to 31 days
Asymptomatic SARS-CoV-2 infection (with a score not exceeding 1 on the WHO Clinical Progression Scale) (Cohort A only)
Cohort A: negative SARS-CoV-2 RT-qPCR* and serology test* at baseline.
*test result from day of dosing (baseline) will be retrospectively determined by the sponsor-provided central laboratory. The designation of Cohorts is used only for the analysis not randomization.
Measured: up to 31 days
Severity of COVID-19 (No, mild, moderate, or severe COVID-19, with a maximum score of 0, 1-3, 4-5, or >= 6,respectively, on the WHO Clinical Progression Scale) (Cohort A)
Cohort A: negative SARS-CoV-2 RT-qPCR* and serology test* at baseline.
*test result from day of dosing (baseline) will be retrospectively determined by the sponsor-provided central laboratory. The designation of Cohorts is used only for the analysis not randomization.
Measured: up to 98 days
Severity of COVID-19 (No, mild, moderate, or severe COVID-19, with a maximum score of 0, 1-3, 4-5, or >= 6,respectively, on the WHO Clinical Progression Scale) (Cohort B)
Cohort B: positive SARS-CoV-2 RT-qPCR test* or positive serology test* at baseline.
*test result from day of dosing (baseline) will be retrospectively determined by the sponsor-provided central laboratory. The designation of Cohorts is used only for the analysis not randomization.
Measured: up to 98 days
Hospitalization due to COVID-19 for >= 24 hours (Cohort A)
Cohort A: negative SARS-CoV-2 RT-qPCR* and serology test* at baseline.
*test result from day of dosing (baseline) will be retrospectively determined by the sponsor-provided central laboratory. The designation of Cohorts is used only for the analysis not randomization.
Measured: up to 98 days
Hospitalization due to COVID-19 for >= 24 hours (Cohort B)
Cohort B: positive SARS-CoV-2 RT-qPCR test* or positive serology test* at baseline.
*test result from day of dosing (baseline) will be retrospectively determined by the sponsor-provided central laboratory. The designation of Cohorts is used only for the analysis not randomization.
Measured: up to 98 days
Hospitalization due to COVID-19 for >= 24 hours or death (Cohort A)
Cohort A: negative SARS-CoV-2 RT-qPCR* and serology test* at baseline.
*test result from day of dosing (baseline) will be retrospectively determined by the sponsor-provided central laboratory. The designation of Cohorts is used only for the analysis not randomization.
Measured: up to 98 days
Hospitalization due to COVID-19 for >= 24 hours or death (Cohort B)
Cohort B: positive SARS-CoV-2 RT-qPCR test* or positive serology test* at baseline.
*test result from day of dosing (baseline) will be retrospectively determined by the sponsor-provided central laboratory. The designation of Cohorts is used only for the analysis not randomization.
Measured: up to 98 days
Death (Cohort A)
Cohort A: negative SARS-CoV-2 RT-qPCR* and serology test* at baseline.
*test result from day of dosing (baseline) will be retrospectively determined by the sponsor-provided central laboratory. The designation of Cohorts is used only for the analysis not randomization.
Measured: up to 98 days
Death (Cohort B)
Cohort B: positive SARS-CoV-2 RT-qPCR test* or positive serology test* at baseline.
*test result from day of dosing (baseline) will be retrospectively determined by the sponsor-provided central laboratory. The designation of Cohorts is used only for the analysis not randomization.
Measured: up to 98 days

Timeline

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

17 Jun 202124 Jul 2022

First posted20 May 2021
Study start17 Jun 2021 (estimated)
Primary completion23 May 2022 (estimated)
Study completion24 Jul 2022 (estimated)

Why it stopped: project terminated

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04894474
Sponsor's protocol ID: 1487-0003
Other IDs: 2021-000408-39
Status last verified: Nov 2021
First submitted: 18 May 2021
Last updated: 8 Nov 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing

Publications

Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
PubMed 35713300
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Randomized, Double-blind, Placebo-controlled, Parallel-group, Group-sequential Study to Evaluate Efficacy, Safety and Tolerability of BI 767551 for Post-exposure Prevention of SARS-CoV-2 Infection in Household Contacts to a Confirmed SARS-CoV-2 Infected Individual
ClinicalTrials.gov ID: NCT04894474
Acronym / sponsor ID: 1487-0003
Conditions: COVID-19
Phase: Phase 2/3
Study type: Interventional
Recruitment status: WithdrawnReason stopped: project terminated
Enrolment: 0 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 17 Jun 2021 (estimated)
Primary completion: 23 May 2022 (estimated)
Study completion: 24 Jul 2022 (estimated)
First posted: 20 May 2021 (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.

Participants are put into 3 groups randomly, which means by chance.

1 group gets BI 767551 via an inhaler and placebo as an infusion
1 group gets BI 767551 as an infusion and placebo via an inhaler
1 group gets placebo both via an inhaler and as an infusion

All participants get study medicine once at study start and after 1 week. Placebo inhaler and infusion look like BI 767551 inhaler and infusion but do not contain any medicine.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
BI 767551 inhalation and placebo intravenous infusion	Experimental	Drug: BI 767551 inhalation, Drug: Placebo intravenous
BI 767551 intravenous infusion and placebo inhalation	Experimental	Drug: BI 767551 intravenous, Drug: Placebo inhalation
Placebo inhalation and placebo intravenous infusion	Placebo comparator	Drug: Placebo intravenous, Drug: Placebo inhalation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

≥ 18 years old, males and females
Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Asymptomatic for Coronavirus Disease 2019 (COVID-19) at time of screening and at randomization
Household contact with exposure to an individual with a diagnosis of Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (i.e. exposure to the index case)
Randomization within 96 hours of collection of the index cases' positive SARS-CoV-2 diagnostic test sample (nucleic acid or antigen-based) from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (NP), or nasal swab, or saliva); based on test sample collection date, not the result date.

Key exclusion criteria (20 listed)

Body weight of less than 40 kg
Residents of skilled nursing facilities. Definition of skilled nursing facility: assisted living facility that typically provides daily nursing care, 24-hour supervision, three meals a day, and assistance with everyday activities.
History of laboratory confirmed SARS-CoV-2 infection (e.g. antigen or nucleic acid test)at any time before screening
Active respiratory or non-respiratory symptoms consistent with COVID-19, in the opinion of the investigator
History of respiratory or non-respiratory symptoms consistent with COVID-19, within the prior 6 months to screening, in the opinion of the investigator

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
BI 767551 intravenousBI 767551 intravenous	Drug	BI 767551 intravenous infusion and placebo inhalation
BI 767551 inhalationBI 767551 inhalation	Drug	BI 767551 inhalation and placebo intravenous infusion
Placebo intravenousPlacebo intravenous	Drug	BI 767551 inhalation and placebo intravenous infusion, Placebo inhalation and placebo intravenous infusion
Placebo inhalationPlacebo inhalation	Drug	BI 767551 intravenous infusion and placebo inhalation, Placebo inhalation and placebo intravenous infusion

Primary outcome

The primary endpoint of this study is symptomatic SARS-CoV-2 infection (RT-qPCR confirmed based on NP swabs, with a score >= 2 on the WHO Clinical Progression Scale) (Cohort A only)
Time frame: up to 31 days
Cohort A: negative SARS-CoV-2 RT-qPCR* and serology test* at baseline. *test result from day of dosing (baseline) will be retrospectively determined by the sponsor-provided central laboratory. The designation of Cohorts is used only for the analysis not randomization. qPCR: Quantitative Reverse Transcription Polymerase chain reaction; WHO: World Health Organisation; The 11-point WHO Clinical Progression Scale ranges from 0 to 10, with a higher score indicating a worsening of the symptoms.

10 secondary outcomes

SARS-CoV-2 infection, with or without symptoms (Cohort A only)
Time frame: up to 31 days
Asymptomatic SARS-CoV-2 infection (with a score not exceeding 1 on the WHO Clinical Progression Scale) (Cohort A only)
Time frame: up to 31 days
Severity of COVID-19 (No, mild, moderate, or severe COVID-19, with a maximum score of 0, 1-3, 4-5, or >= 6,respectively, on the WHO Clinical Progression Scale) (Cohort A)
Time frame: up to 98 days
Severity of COVID-19 (No, mild, moderate, or severe COVID-19, with a maximum score of 0, 1-3, 4-5, or >= 6,respectively, on the WHO Clinical Progression Scale) (Cohort B)
Time frame: up to 98 days
Hospitalization due to COVID-19 for >= 24 hours (Cohort A)
Time frame: up to 98 days
Hospitalization due to COVID-19 for >= 24 hours (Cohort B)
Time frame: up to 98 days
Hospitalization due to COVID-19 for >= 24 hours or death (Cohort A)
Time frame: up to 98 days
Hospitalization due to COVID-19 for >= 24 hours or death (Cohort B)
Time frame: up to 98 days
Death (Cohort A)
Time frame: up to 98 days
Death (Cohort B)
Time frame: up to 98 days

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 Nov 2021.
Derived from this study: PubMed 35713300Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing BI 767551 intravenous and BI 767551 inhalation in people with COVID-19, run by Boehringer Ingelheim.

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 8 inclusion and 20 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 Nov 2021. 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. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

The primary endpoint of this study is symptomatic SARS-CoV-2 infection (RT-qPCR confirmed based on NP swabs, with a score >= 2 on the WHO Clinical Progression Scale) (Cohort A only) (time frame: up to 31 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 NCT04894474, which also lists 2 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 Nov 2021.