A Phase II/III seamless, randomised, double-blind, placebo-controlled, parallel-group,group-sequential study to evaluate efficacy, safety and tolerability of BI 767551 for thetreatment of symptomatic, non-hospitalized adults with mild to moderate COVID-19.

Boehringer Ingelheim0 sites200 target enrollmentMarch 30, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Boehringer Ingelheim
Enrollment: 200
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 30, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Eligibility 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 65

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 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\.