COVID-19 MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Boehringer Ingelheim Portugal, Lda
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. = 18 years old, males and females. 2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. 3. Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (NP or nasal swab or saliva) collected no more than 72 hours prior to start of treatment. 4. Patients experienced mild to moderate 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. 5. 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. 6. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Body weight of less than 40 kg. 2. Severe or critical COVID-19 including at least one of: o Oxygen saturation (SpO2) = 93 % on room air or on their usual level of oxygen supplementation in case of chronic oxygen use o Ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) < 300 (in case arterial blood sample was taken) o Respiratory rate = 30/min or heart rate = 125/min. Measure should be obtained at rest by study staff within 24 hours of start of treatment. o History of hospitalization for COVID-19 o 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. 3. Receipt of intraveneous immunoglobulin within 12 weeks prior to Visit number 2. 4. Receipt of COVID-19 convalescent plasma treatment at any time prior to Visit 2. 5. Receipt of any SARS-CoV-2 monoclonal antibody treatment at any time prior to Visit 2. 6. Receipt of SARS-CoV-2 vaccine at any time prior to Visit 2. 7. Receipt of an investigational product for COVID-19 within 5 half-lives prior to Visit 2. 8. Receipt of systemic steroids (e.g. prednisone, dexamethasone) within 4 weeks prior to Visit 2 unless used for chronic condition (see Section 4.2.2.1). 9. Patients 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. 10. 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 study entry. 11. Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study. 12. Patients 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 patient an unreliable trial participant). 13. Currently enrolled in any other type of medical research judged not to be compatible with this study. 14. Known allergy/sensitivity or any hypersensitivity to any of the components used in the formulation of the interventions. 15. Previous enrolment in this trial. Patients participating in Phase II are not eligible for Phase III. Re-screening is allowed once, for repeat of 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. 16. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of this trial is to evaluate the concept of pharmacological activity of BI 767551 in non-hospitalized patients with mild to moderate COVID-19 symptoms and to identify a potentially efficacious and safe dose regimen from Phase II part to take into the Phase III part. The additional objective for Phase II is the assessment of the pharmacokinetics (PK) for the inhaled and i.v. doses and the evaluation of the development of anti-drug antibodies (ADA) after single dose of BI 767551 in patients with mild to moderate COVID-19. The Phase III part of the trial will aim to confirm efficacy, safety and tolerability of the dose regimen of BI 767551 selected from the Phase II part in comparison to placebo in non hospitalized patients with mild to moderate COVID-19 symptoms. ;Secondary Objective: Secondary objectives of Phase II and Phase III are to numerically compare the BI 767551 doses and routes of administration to placebo for virological outcomes. ;Primary end point(s): 1) Phase II: Time-weighted change from baseline in viral shedding over 8 days in site collected nasopharyngeal (NP) swabs by RT-qPCR, defined as a change from baseline in log10 viral load;Timepoint(s) of evaluation of this end point: 1) 8 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Phase II: Time-weighted change from baseline in viral shedding over 29 days in site collected NP swabs by RT-qPCR, defined as a change from baseline in log10 viral load. 2) Phase II: Loss of detection of SARS-CoV-2 RNA by site collected NP swab at Day 4, 8, 15, 22 and 29. 3) Phase III: Time to death over 29 days 4) Phase III: Hospitalization by Day 29 5) Phase III: Hypoxia or hospitalization or death from any cause by Day 29 6) Phase III: Hypoxia by Day 29 7) Phase III: Time to clinical improvement over 29 days, defined as the time to either an improvement of two points on the 11-point WHO Clinical Progression Scale or a score of 0 on the Clinical Progression Scale, whichever comes first. 8) Phase III: Time to loss of detection of SARS-CoV-2 RNA by site collected NP swabs over 29 days ;Timepoint(s) of evaluation of this end point: 1) 29 days 2) 29 days 3) 29 days 4) 29 days 5) 29 days 6) 29 days 7) 29 days 8) 29 days | — |
Countries
Belgium, Canada, Denmark, France, Germany, Netherlands, Poland, Portugal, Russian Federation, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactCT Disclosure & Data Transparency
Boehringer Ingelheim Pharma GmbH &Co KG
Outcome results
None listed