COVID-19Phase 2/3NCT04822701

A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19

A Phase 2/3 study testing BI 767551 intravenous and BI 767551 inhaled in people with COVID-19, run by Boehringer Ingelheim at 5 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study is open to adults with mild to moderate symptoms of COVID-19 (coronavirus disease). The purpose of this study is to find out whether a medicine called BI 767551 helps people with COVID-19. BI 767551 is an antibody against the coronavirus. The study has 2 parts. 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 inhaled
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5 participants
Where: 5 sitesin 2 countries
Study dates: 21 Apr 2021to 4 Oct 2021
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Documentation of laboratory-confirmed Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (nasopharyngeal (NP) or nasal swab or saliva) collected no more than 72 hours prior to start of treatment
Patients experienced mild to moderate Coronavirus Disease 2019 (COVID-19)-related symptoms or measured fever for no more than 5 days prior to start of treatment where symptoms are defined by fever, feeling feverish, fatigue, cough, shortness of breath at rest or during activity, sore throat, body pain or muscle pain/ aches, chills, headache, nasal obstruction or congestion, loss of smell or taste, nausea, diarrhea, vomiting, or dysgeusia
One or more of the following signs/symptoms present on day of start of treatment: fever, feeling feverish, fatigue, cough, shortness of breath at rest or during activity, sore throat, body pain or muscle pain/ aches, chills, headache, nasal obstruction or congestion, loss of smell or taste, nausea, diarrhea, vomiting, or dysgeusia
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 ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly

Who cannot join

Body weight of less than 40 kg
Severe or critical COVID-19 including at least one of
Oxygen saturation (SpO2) ≤ 93 % on room air or on their usual level of oxygen supplementation in case of chronic oxygen use
Ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) < 300 (in case arterial blood sample was taken)
History of hospitalization for COVID-19
Current or imminent need for hospitalization or immediate medical attention in the clinical opinion of the site investigator. Does not include patients hospitalized for isolation only

Show all 13Show 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 Further exclusion criteria apply.
Previous enrolment in this trial. Patients participating in Phase II are not eligible for Phase III. Re-screening is allowed once, for repeat of Quantitative Reverse Transcription Polymerase chain reaction (RT-qPCR) or antigen SARS-CoV-2 test, if required. The test method used for initial screening (RT-qPCR or antigen) should be used for re-screening.

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

United States4 sites

Pharmatex Research
Amarillo, Texas, 79109
Advanced Surgeons and Physicians Network
Houston, Texas, 77027
Ocean Blue Medical Research Center, Inc.
Miami Springs, Florida, 33166
Crossroads Clinical Research
Victoria, Texas, 77904

Other trials in United States

Spain1 site

Hospital Universitario Infanta Leonor
Madrid, 28031

Other trials in Spain

About this study

Official title: A Phase II/III Seamless, Randomized, Double-blind, Placebo-controlled, Parallel-group, Group-sequential Study to Evaluate Efficacy, Safety and Tolerability of BI 767551 for the Treatment of Symptomatic, Non-hospitalized Adults With Mild to Moderate COVID-19.

The study has 2 parts.

Part 1 wants to find out the best dose of BI 767551 given as infusion into a vein. It also tests how BI 767551 is taken up by the body when taken via an inhaler. Participants are put into 4 groups by chance. Participants get BI 767551 or placebo once.

1 group gets a high dose of BI 767551 as an infusion into a vein
1 group gets a low dose of BI 767551 as an infusion into a vein
1 group gets BI 767551 via an inhaler
1 group gets placebo both as an infusion into a vein and via an inhaler

The placebo infusion and inhaler look like the BI 767551 infusion and inhaler but do not contain any medicine.

Doctors check how BI 767551 reduces the amount of coronavirus. Once the best dose of BI 767551 is found, part 2 of the study tests BI 767551 in a larger group of people. Also, in part 2, the participants get BI 767551 or placebo as an infusion into a vein once. In this part, doctors will check how many people need to be treated in a hospital or die. The results will be compared between the groups.

For each part, participants are in the study for about 13 weeks. During this time, they visit the study site about 8 times and get about 3 remote visits.

The doctors also regularly check participants' health and take note of any unwanted effects of BI 767551.

Conditions: COVID-19
Being tested: BI 767551 intravenous, BI 767551 inhaled, Placebo intravenous, Placebo inhaled
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 inhaledDrug
BI 767551 inhaled
Placebo intravenousDrug
Placebo intravenous
Placebo inhaledDrug
Placebo inhaled

Study groups in NCT04822701
Study group	Role	What they receive
Phase II, Arm 1: Placebo intravenous (i.v.) + placebo inhaled	Placebo comparator	Single dose of sterile normal saline (NaCl 0.9%) used as placebo for intravenous (i.v.) was administered as intravenous infusion over a period of 60 minutes plus a single inhaled of solvent for dilution of BI 767551 used as placebo for inhalation administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1, followed by a 90-day follow-up period. The inhalation procedure was to start approximately 25 min after the start of infusion. Receives: Drug: Placebo intravenous; Drug: Placebo inhaled
Phase II, Arm 2: BI 767551 10 milligrams (mg)/kilogram (kg) intravenous (i.v.) + placebo inhaled	Experimental	Not described Receives: Drug: BI 767551 intravenous; Drug: Placebo inhaled
Phase II, Arm 3: BI 767551 40 mg/kg intravenous (i.v.) + placebo inhaled	Experimental	Not described Receives: Drug: BI 767551 intravenous; Drug: Placebo inhaled
Phase II, Arm 4: Placebo intravenous (i.v.) + BI 767551 250 mg inhaled	Experimental	Single dose of sterile normal saline (NaCl 0.9%) used as placebo for intravenous (i.v.) was administered as intravenous infusion over a period of 60 minutes plus a single inhaled of 250 milligrams (mg) of BI 767551 administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1, followed by a 90-day follow-up period. The inhalation procedure was to start approximately 25 min after the start of infusion. Receives: Drug: BI 767551 inhaled; Drug: Placebo intravenous
Phase III, Arm 1: BI 767551 (medium or high dose infusion) or low dose inhalation	Experimental	Not described Receives: Drug: BI 767551 intravenous
Phase III, Arm 2: Placebo	Placebo comparator	Not described Receives: Drug: Placebo intravenous

What is being measured

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

Phase II: Time-weighted Change From Baseline in Viral Shedding Over 8 Days in Site Collected Nasopharyngeal (NP) Swabs by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR)
Time-weighted change from baseline in viral shedding over 8 days in site collected nasopharyngeal (NP) swabs by Quantitative Reverse Transcription Polymerase chain reaction (RT-qPCR), defined as a absolute change from baseline in log10 viral load, is reported.
Measured: Up to 8 days
Phase II: Time-weighted Change From Baseline in Viral Shedding Over 29 Days in Site Collected Nasopharyngeal (NP) Swabs by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR)
Time-weighted change from baseline in viral shedding over 29 days in site collected nasopharyngeal (NP) swabs by Quantitative Reverse Transcription Polymerase chain reaction (RT-qPCR), defined as a absolute change from baseline in log10 viral load, is reported.
Measured: Up to 29 days

Secondary outcomes (1)

Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29
Number of participants with loss of detection of Severe acute respiratory syndrome coronavirus 2 ribonucleic acid (SARS-CoV-2 RNA) by site collected NP swab at Day 4, 8, 15, 22 and 29 is report. The "Yes" = loss of detection of SARS-CoV-2 RNA; "No" = SARS-CoV-2 RNA detected; "Missing" = not evaluable.
Measured: At Day 4, Day 8, Day 15, Day 22, and Day 29

Timeline

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

21 Apr 20214 Oct 2021

First posted30 Mar 2021
Study start21 Apr 2021
Primary completion2 Jul 2021
Study completion4 Oct 2021

Why it stopped: not due to safety reasons

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)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
Model description: This trial consists of two phases: Exploratory Phase II: Randomised, double-blind, placebo controlled, doubledummy,Phase II, parallel group design comparing different doses and modes of administration of BI 767551 to placebo. Confirmatory Phase III: Randomised, double-blind, placebo-controlled, parallel group, Phase III comparing BI 767551 to placebo.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04822701
Sponsor's protocol ID: 1487-0001
Other IDs: 2020-005588-29
Status last verified: Jul 2022
First submitted: 29 Mar 2021
Last updated: 28 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Publications

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?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II/III Seamless, Randomized, Double-blind, Placebo-controlled, Parallel-group, Group-sequential Study to Evaluate Efficacy, Safety and Tolerability of BI 767551 for the Treatment of Symptomatic, Non-hospitalized Adults With Mild to Moderate COVID-19.
ClinicalTrials.gov ID: NCT04822701
Acronym / sponsor ID: 1487-0001
Conditions: COVID-19
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason stopped: not due to safety reasons
Enrolment: 5 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 21 Apr 2021 (actual)
Primary completion: 2 Jul 2021 (actual)
Study completion: 4 Oct 2021 (actual)
First posted: 30 Mar 2021 (actual)
Results: Posted 21 Jul 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study has 2 parts.

1 group gets a high dose of BI 767551 as an infusion into a vein
1 group gets a low dose of BI 767551 as an infusion into a vein
1 group gets BI 767551 via an inhaler
1 group gets placebo both as an infusion into a vein and via an inhaler

The placebo infusion and inhaler look like the BI 767551 infusion and inhaler but do not contain any medicine.

For each part, participants are in the study for about 13 weeks. During this time, they visit the study site about 8 times and get about 3 remote visits.

The doctors also regularly check participants' health and take note of any unwanted effects of BI 767551.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6
Model description: This trial consists of two phases: Exploratory Phase II: Randomised, double-blind, placebo controlled, doubledummy,Phase II, parallel group design comparing different doses and modes of administration of BI 767551 to placebo. Confirmatory Phase III: Randomised, double-blind, placebo-controlled, parallel group, Phase III comparing BI 767551 to placebo.

Arm	Type	Receives
Phase II, Arm 1: Placebo intravenous (i.v.) + placebo inhaled	Placebo comparator	Drug: Placebo intravenous, Drug: Placebo inhaledSingle dose of sterile normal saline (NaCl 0.9%) used as placebo for intravenous (i.v.) was administered as intravenous infusion over a period of 60 minutes plus a single inhaled of solvent for dilution of BI 767551 used as placebo for inhalation administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1, followed by a 90-day follow-up period. The inhalation procedure was to start approximately 25 min after the start of infusion.
Phase II, Arm 2: BI 767551 10 milligrams (mg)/kilogram (kg) intravenous (i.v.) + placebo inhaled	Experimental	Drug: BI 767551 intravenous, Drug: Placebo inhaled
Phase II, Arm 3: BI 767551 40 mg/kg intravenous (i.v.) + placebo inhaled	Experimental	Drug: BI 767551 intravenous, Drug: Placebo inhaled
Phase II, Arm 4: Placebo intravenous (i.v.) + BI 767551 250 mg inhaled	Experimental	Drug: BI 767551 inhaled, Drug: Placebo intravenousSingle dose of sterile normal saline (NaCl 0.9%) used as placebo for intravenous (i.v.) was administered as intravenous infusion over a period of 60 minutes plus a single inhaled of 250 milligrams (mg) of BI 767551 administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1, followed by a 90-day follow-up period. The inhalation procedure was to start approximately 25 min after the start of infusion.
Phase III, Arm 1: BI 767551 (medium or high dose infusion) or low dose inhalation	Experimental	Drug: BI 767551 intravenous
Phase III, Arm 2: Placebo	Placebo comparator	Drug: Placebo intravenous

Who may qualify

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

Key inclusion criteria (6 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
Documentation of laboratory-confirmed Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (nasopharyngeal (NP) or nasal swab or saliva) collected no more than 72 hours prior to start of treatment
Patients experienced mild to moderate Coronavirus Disease 2019 (COVID-19)-related symptoms or measured fever for no more than 5 days prior to start of treatment where symptoms are defined by fever, feeling feverish, fatigue, cough, shortness of breath at rest or during activity, sore throat, body pain or muscle pain/ aches, chills, headache, nasal obstruction or congestion, loss of smell or taste, nausea, diarrhea, vomiting, or dysgeusia
One or more of the following signs/symptoms present on day of start of treatment: fever, feeling feverish, fatigue, cough, shortness of breath at rest or during activity, sore throat, body pain or muscle pain/ aches, chills, headache, nasal obstruction or congestion, loss of smell or taste, nausea, diarrhea, vomiting, or dysgeusia

Key exclusion criteria (13 listed)

Body weight of less than 40 kg
Severe or critical COVID-19 including at least one of
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

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	Phase II, Arm 2: BI 767551 10 milligrams (mg)/kilogram (kg) intravenous (i.v.) + placebo inhaled, Phase II, Arm 3: BI 767551 40 mg/kg intravenous (i.v.) + placebo inhaled, Phase III, Arm 1: BI 767551 (medium or high dose infusion) or low dose inhalation
BI 767551 inhaledBI 767551 inhaled	Drug	Phase II, Arm 4: Placebo intravenous (i.v.) + BI 767551 250 mg inhaled
Placebo intravenousPlacebo intravenous	Drug	Phase II, Arm 1: Placebo intravenous (i.v.) + placebo inhaled, Phase II, Arm 4: Placebo intravenous (i.v.) + BI 767551 250 mg inhaled, Phase III, Arm 2: Placebo
Placebo inhaledPlacebo inhaled	Drug	Phase II, Arm 1: Placebo intravenous (i.v.) + placebo inhaled, Phase II, Arm 2: BI 767551 10 milligrams (mg)/kilogram (kg) intravenous (i.v.) + placebo inhaled, Phase II, Arm 3: BI 767551 40 mg/kg intravenous (i.v.) + placebo inhaled

Primary outcome

Phase II: Time-weighted Change From Baseline in Viral Shedding Over 8 Days in Site Collected Nasopharyngeal (NP) Swabs by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR)
Time frame: Up to 8 days
Time-weighted change from baseline in viral shedding over 8 days in site collected nasopharyngeal (NP) swabs by Quantitative Reverse Transcription Polymerase chain reaction (RT-qPCR), defined as a absolute change from baseline in log10 viral load, is reported.
Phase II: Time-weighted Change From Baseline in Viral Shedding Over 29 Days in Site Collected Nasopharyngeal (NP) Swabs by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR)
Time frame: Up to 29 days
Time-weighted change from baseline in viral shedding over 29 days in site collected nasopharyngeal (NP) swabs by Quantitative Reverse Transcription Polymerase chain reaction (RT-qPCR), defined as a absolute change from baseline in log10 viral load, is reported.

1 secondary outcome

Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29
Time frame: At Day 4, Day 8, Day 15, Day 22, and Day 29

Results and safety

Results posted to the registry on 21 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Intravenous (i.v.) + Placebo Inhaled	4	0
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled	1	1

Primary outcome: Phase II: Time-weighted Change From Baseline in Viral Shedding Over 8 Days in Site Collected Nasopharyngeal (NP) Swabs by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR)

Time frame: Up to 8 days. Mean (Standard Deviation). Unit: log10 copies / milliliter

Measure	Placebo Intravenous (i.v.) + Placebo Inhaled n = 2	Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled n = 1
Value	0.15 (1.25)	-2.84 (NA)

Population analysed: Modified Intention-To-Treat set (mITT): This subject set includes all randomised subjects that received any amount of study drug and who have at least a measurable baseline value (above Lower limit of quantification (LLOQ)) and a second measurement in the first week (up to 7 days after drug intake) of SARS-CoV-2 RNA by site collected nasopharyngeal (NP) swab.

Primary outcome: Phase II: Time-weighted Change From Baseline in Viral Shedding Over 29 Days in Site Collected Nasopharyngeal (NP) Swabs by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR)

Time frame: Up to 29 days. Mean (Standard Deviation). Unit: log10 copies / milliliter

Measure	Placebo Intravenous (i.v.) + Placebo Inhaled n = 2	Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled n = 1
Value	-2.09 (1.60)	-4.18 (NA)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From dosing until end of 90-day follow-up period, up to 91 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Intravenous (i.v.) + Placebo Inhaled	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Limitations and caveats (from the sponsor): This trial was prematurely discontinued due to sponsor decision. 4 participants were enrolled in the Phase II "Placebo intravenous (i.v.) + placebo inhaled" group and 1 participant in the "Placebo intravenous (i.v.) + BI 250 mg inhaled" group. No patients were entered in the planned Phase II "BI 10 milligrams (mg)/kilogram (kg) intravenous (i.v.) + placebo inhaled" and "BI 40 mg/kg i.v. + placebo inhaled" groups. Phase III part was not conducted.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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: Yes. After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

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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.

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing BI 767551 intravenous and BI 767551 inhaled in people with COVID-19, run by Boehringer Ingelheim at 5 sites in 2 countries.

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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Spain. 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. 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?

Yes. Results are posted in the registry (first posted 21 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Phase II: Time-weighted Change From Baseline in Viral Shedding Over 8 Days in Site Collected Nasopharyngeal (NP) Swabs by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR) (time frame: Up to 8 days). The study lists 2 primary outcomes in all. 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 NCT04822701, which also lists 1 linked publication.

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 28 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.