A Study to Test Whether BI 767551 Can Prevent COVID-19 in People Who Have Been Exposed to SARS-CoV-2
NCT ID: NCT04894474
Last Updated: 2021-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2/PHASE3
INTERVENTIONAL
2021-06-17
2022-07-24
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BI 767551 inhalation and placebo intravenous infusion
BI 767551 inhalation
BI 767551 inhalation
Placebo intravenous
Placebo intravenous
BI 767551 intravenous infusion and placebo inhalation
BI 767551 intravenous
BI 767551 intravenous
Placebo inhalation
Placebo inhalation
Placebo inhalation and placebo intravenous infusion
Placebo intravenous
Placebo intravenous
Placebo inhalation
Placebo inhalation
Interventions
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BI 767551 intravenous
BI 767551 intravenous
BI 767551 inhalation
BI 767551 inhalation
Placebo intravenous
Placebo intravenous
Placebo inhalation
Placebo inhalation
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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References
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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.
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.
Related Links
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Related Info
Other Identifiers
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2021-000408-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1487-0003
Identifier Type: -
Identifier Source: org_study_id