EUCTR2020-001872-13-PT进行中（未招募）1 期
Evaluation of the efficacy and safety of PTC299 in hospitalized subjects with COVID-19 (FITE19) - FITE19
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 189
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject (or legally authorized representative) is willing and able to provide informed consent and comply with all protocol requirements.
- •2. Agrees to the collection of nasopharyngeal swabs and venous blood and all other protocol-specified procedures.
- •3. Male or non-pregnant female adult =18 years of age at time of enrollment.
- •4. Hospitalized and has laboratory-confirmed infection with SARS CoV-2.
- •5. Symptom onset was =14 days prior to Screening.
- •6. Has SpO2 <94% on room air
- •7. Has at least one of respiratory rate >24 breaths/minute or cough
- •8. Lung involvement as confirmed by radiographic infiltrates observed on imaging (chest X-ray, CT scan, or an equivalent test)
- •9. Women of childbearing potential (as defined in (CTFG 2014)) must have a negative pregnancy test at screening and agree to abstinence or the use at least one of the following highly
- •effective forms of contraception (with a failure rate of <1% per year when used consistently and correctly). Contraception or abstinence must be continued for the duration of the study
- •following discharge from the hospital, and for up to 50 days after the last dose of study drug:
- •combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- •- intravaginal
- •- transdermal
- •progestogen-only hormonal contraception associated with inhibition of ovulation:
- •- injectable
- •- implantable
- •intrauterine device
- •intrauterine hormone-releasing system
- •vasectomized partner with confirmed azoospermia´
- •All females will be considered of childbearing potential unless they are postmenopausal (at least 12 months consecutive amenorrhea in the appropriate age group without other known or
- •suspected cause) or have been sterilized surgically (eg, bilateral tubal ligation, hysterectomy, bilateral oophorectomy).
- •10. Men sexually active with women of childbearing potential who have not had a vasectomy must agree to use a barrier method of birth control during the study following discharge from the hospital and for up to 50 days after the last dose of study drug.
- •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 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 190
排除标准
- •1. Requires mechanical ventilation
- •2. Current participation in any other interventional study.
- •3. Severe liver disease as defined by alanine transaminase/aspartate transaminase levels (ALT/AST) >4 times the upper limit of normal.
- •4. Lymphocyte count <500 lymphocytes/µL or hemoglobin <11.0 g/dL
- •5. Stage 4 severe chronic kidney disease or requiring dialysis (ie, estimated glomerular filtration rate <30)
- •6. Any other condition, that in the opinion of the investigator, may be cause to exclude the subject from the study.
- •7. Use of steroids (except dexamethasone), drugs metabolized by CYP2D6, CYP2C inducers, IL-6 neutralizing antibodies, IL-6 receptor inhibitors, or any investigational therapy.
- •8. Pregnancy or breast feeding.
- •9. Anticipated transfer to another hospital which is not a study site within 72 hours.
- •10. Known allergy to PTC299 or excipients
研究者
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