- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04822701
A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19
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.
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Madrid, Spain, 28031
- Hospital Universitario Infanta Leonor
-
-
-
-
Florida
-
Miami Springs, Florida, United States, 33166
- Ocean Blue Medical Research Center, Inc.
-
-
Texas
-
Amarillo, Texas, United States, 79109
- PharmaTex Research
-
Houston, Texas, United States, 77027
- Advanced Surgeons and Physicians Network
-
Victoria, Texas, United States, 77904
- Crossroads Clinical Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria phase II and III:
- ≥ 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
Exclusion criteria phase II and III:
- 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
- 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.
Exclusion criterion phase III only:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Phase II, Arm 1: Placebo intravenous (i.v.) + placebo inhaled
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.
|
Placebo intravenous
Placebo inhaled
|
Experimental: Phase II, Arm 2: BI 767551 10 milligrams (mg)/kilogram (kg) intravenous (i.v.) + placebo inhaled
|
Placebo inhaled
BI 767551 intravenous
|
Experimental: Phase II, Arm 3: BI 767551 40 mg/kg intravenous (i.v.) + placebo inhaled
|
Placebo inhaled
BI 767551 intravenous
|
Experimental: Phase II, Arm 4: Placebo intravenous (i.v.) + BI 767551 250 mg inhaled
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.
|
Placebo intravenous
BI 767551 inhaled
|
Experimental: Phase III, Arm 1: BI 767551 (medium or high dose infusion) or low dose inhalation
|
BI 767551 intravenous
|
Placebo Comparator: Phase III, Arm 2: Placebo
|
Placebo intravenous
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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 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.
|
Up to 29 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
At Day 4, Day 8, Day 15, Day 22, and Day 29
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1487-0001
- 2020-005588-29 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
First Affiliated Hospital Xi'an Jiaotong UniversityShangluo Central Hospital; Ankang Central Hospital; Hanzhong Central Hospital; Yulin... and other collaboratorsRecruitingCOVID-19 | Post-COVID-19 Syndrome | Post-Acute COVID-19 | Acute COVID-19China
Clinical Trials on Placebo intravenous
-
Eli Lilly and CompanyCompleted
-
Astellas Pharma Europe B.V.CompletedHealthy Subjects | Pharmacokinetics of ASP6294United Kingdom
-
Galapagos NVMorphoSys AGCompletedHealthy | Dermatitis, AtopicBelgium, Hungary, Moldova, Republic of, Romania
-
Boehringer IngelheimWithdrawn
-
Novartis PharmaceuticalsCompletedPigmented Villonodular Synovitis | PVNS | Giant Cell Tumor of the Tendon Sheath | GCCTS | Tenosynovial Giant Cell Tumor Localized or Diffused Type | GCTSUnited States, Switzerland
-
Asklepion Pharmaceuticals, LLCCompletedAtrial Septal Defect | Atrioventricular Septal Defect | Ventricular Septal DefectUnited States
-
MicuRxWorldwide Clinical TrialsCompleted
-
Aptarion Biotech AGCompleted
-
Serum Institute of India Pvt. Ltd.PPDCompleted
-
Royan InstituteTehran University of Medical Sciences; Iranian Stem Cell CouncilUnknownDiabetes Mellitus | Diabetes Mellitus, Type 1 | Diabetes Mellitus, Insulin-DependentIran, Islamic Republic of