NL-OMON51124撤回2 期
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. - A study to test BI 767551 in people with mild to moderate COVID-19 symptoms
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 10
研究概览
简要总结
Trial never started
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •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.
排除标准
- •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
- •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
- •5. Receipt of any SARS-CoV-2 monoclonal antibody treatment at any time prior to
- •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
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