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

NCT04822701 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 1487-00012020-005588-29
• Study Type: interventional
• Target: 5
• Locations: 2 countries
• Sites: 5

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  At Day 4, Day 8, Day 15, Day 22, and Day 29

Study Arms (6)

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.

Drug: Placebo intravenous; Drug: Placebo inhaled

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

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.

Drug: BI 767551 inhaled; Drug: Placebo intravenous

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

Interventions

BI 767551 intravenous DRUG

BI 767551 intravenous

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 inhaled DRUG

BI 767551 inhaled

Phase II, Arm 4: Placebo intravenous (i.v.) + BI 767551 250 mg inhaled

Placebo intravenous DRUG

Placebo intravenous

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 inhaled DRUG

Placebo inhaled

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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
• \- 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (5)

Ocean Blue Medical Research Center, Inc.

Miami Springs, Florida, 33166, United States

Location

Pharmatex Research

Amarillo, Texas, 79109, United States

Location

Advanced Surgeons and Physicians Network

Houston, Texas, 77027, United States

Location

Crossroads Clinical Research

Victoria, Texas, 77904, United States

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Related Publications (1)

• 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.

  PMID: 34473343 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: March 30, 2021
• Study Start: April 21, 2021
• Primary Completion: July 2, 2021
• Study Completion: October 4, 2021
• Last Updated: July 28, 2022
• Results First Posted: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After all regulatory activities are completed in the United States (US) and European Union (EU) for the product and indication, and after the primary manuscript has been accepted for publication.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.

Locations

US (4); ES (1)