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 the treatment of symptomatic, non-hospitalized adults with mild to moderate COVID-19.
- Conditions
- Coronavirus Disease 2019 (COVID-19)severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)1004743810024970
- Registration Number
- NL-OMON51124
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Trial never started
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 10
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.
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint in Phase II is the time-weighted change from baseline in<br /><br>viral shedding over 8 days (in site collected) nasopharyngeal swabs by RT-qPCR,<br /><br>defined as a change from baseline in log10 viral load. Refer to Section 7.2.3<br /><br>of the protocol for further details.<br /><br><br /><br>The primary endpoint in Phase III is hospitalization or death from any cause by<br /><br>Day 29.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints in Phase II are:<br /><br>* Time-weighted change from baseline in viral shedding over 29 days in site<br /><br>collected NP<br /><br>swabs by RT-qPCR, defined as a change from baseline in log10 viral load.<br /><br>* Loss of detection of SARS-CoV-2 RNA by site collected NP swab at Day 4, 8,<br /><br>15, 22<br /><br>and 29.<br /><br>2.1.3.2 Secondary endpoints in Phase III<br /><br>The secondary endpoints in the Phase III are:<br /><br>* Time to death over 29 days<br /><br>* Hospitalization by Day 29<br /><br>* Hypoxia or hospitalization or death from any cause by Day 29<br /><br>* Hypoxia by Day 29<br /><br>* Time to clinical improvement over 29 days, defined as the time to either an<br /><br>improvement<br /><br>of two points on the 11-point WHO Clinical Progression Scale or a score of 0 on<br /><br>the<br /><br>Clinical Progression Scale, whichever comes first.<br /><br>* Time to loss of detection of SARS-CoV-2 RNA by site collected NP swabs over<br /><br>29 days</p><br>