EUCTR2022-003478-22-DE进行中（未招募）1 期
A randomised, placebo-controlled, double-blind parallel-group trial to assess the efficacy and safety of PB432 in outpatients with COVID-19 induced acute respiratory infection - COVARI-2 study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1Male / female / diverse adults between =18 and =60 years of age at enrolment
- •2Acute coughing with new onset of cough, i.e., starting within 48 h (or 2 days) before enrolment and with sufficiently high
- •coughing intensity, defined as a minimum score of 5 on 11-point NRS at Visit 1
- •3Signed informed consent and data protection declaration for SARS-CoV-2 antigen test prior to initiation of this trial-related
- •4Confirmed SARS-CoV-2 infection (by test on-site) as determined by antigen test at Visit 1 before randomisation
- •5 Signed informed consent and data protection declaration prior to initiation of any further trial procedures beyond SARS-CoV-2
- •antigen test
- •Note: For screening activities in first stage (confirmation of SARS-CoV-2 by antigen test) only inclusion criteria 1., 2. and 3. must be confirmed
- •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 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1Any clinical indication for immediate hospitalisation
- •2Need for supplemental oxygen
- •3Clinical indication for immediate systemic antibiotic therapy
- •4Patients that at the discretion of the responsible physician are likely to benefit from COVID-19-specific antiviral therapy
- •5Medical history suggesting chronic or readily recurrent sinusitis or bronchitis i.e., without previous acute sinusitis or bronchitis
- •6At time of study inclusion chronic cough (> 6 weeks), anamnestic knowledge of bronchiectasis, suspected pneumonia, and mucoviscidosis unless consistently treated at a constant dose from 1 week
- •before Visit 1
- •7Exacerbation of COPD or asthma bronchiale with the need of systemic steroids
- •8Acute symptoms of a known allergic rhinitis
- •9Use of not permitted previous / concomitant medication or therapy and any other medication regularly used to treat concomitant or chronic diseases that is known to interfere with cough or mucus formation
- •10Use of, or anticipated use of inhaled, intranasal, or systemic steroid treatment during the trial
- •11Inflammatory gastrointestinal or severe hepatic disease or inflammation of the gallbladder or bile duct at the time of inclusion or within the last 6 months before Visit 1
- •12Known hypersensitivity to trial medication or its excipients
- •13Patients with rare hereditary problems of fructose intolerance
- •14Only for patients of childbearing potential:
- •Pregnancy, positive urine pregnancy test on Day 0, breast feeding or no use of effective contraception
- •15Malignancy (active = running or immediately planned treatment options like e.g., surgery, chemo- or radiation therapy) or condition after carcinoma not longer than 5 years without relapse, which would make it in the opinion of the investigator unsafe or unsuitable for the patient to participate in this clinical trial.
- •Watchful waiting in case of prostate carcinoma is not considered as an active malignancy, provided that the patient is free of symptoms and without therapy regarding the prostate carcinoma. Such a constellation does not fulfil this exclusion criterion. Final decision is at the discretion of the investigator
- •16Participation in clinical trial within 30 days before screening
- •17Known to be or suspected of being unable to comply with the study protocol (e.g., no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history)
- •18Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope, and possible impact of the trial
- •19Patient in custody by juridical or official order evidence of an uncooperative attitude
- •20Patient, who is a member of the staff of the study center, staff of the sponsor or CRO, the investigator him- / herself or close relatives of the investigator
研究者
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