EUCTR2020-002120-37-GB进行中（未招募）1 期
An open-label, adaptive randomized, controlled multicenter study to evaluate the efficacy and safety of RESP301 plus standard of care (SOC) compared to SOC alone in hospitalized participants with COVID-19 requiring supplemental oxygen (NOCoV2)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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. Participant is =18 years of age, at the time of signing the informed consent.
- •2. Participant has laboratory-confirmed SARS-CoV-2 infection as determined by reverse transcriptase polymerase chain reaction (RT-PCR) or other approved clinical testing prior to randomization.
- •3. Participant is hospitalized in relation to COVID-19, requiring supplemental oxygen to maintain SpO2 at a safe level (WHO level 4).
- •4. Participant is male or female. All females of childbearing potential, including pregnant females, must consent to urine pregnancy testing at screening to be eligible for the study.
- •(Females who are not of childbearing potential do not need to undergo a pregnancy test at screening).
- •5. Participant is capable of giving signed informed consent as described in the protocol.
- •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 195
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 105
排除标准
- •1. Rapidly deteriorating or likely to require escalation to high flow oxygen, invasive or non-invasive ventilatory support within 24 hours according to Investigator’s opinion.
- •2. Unable to safely receive a nebulized treatment for approximately 4 minutes according to Investigator’s opinion.
- •3. Unable to receive or considered ineligible for invasive or non-invasive ventilatory support.
- •4. History of methemoglobinemia.
- •5. Uncontrolled asthma or history of severe bronchospasm.
- •6. Severe (requiring baseline oxygen therapy > 12 h/day prehospitalization) chronic respiratory disease (e.g., known COPD, pulmonary arterial hypertension, idiopathic pulmonary fibrosis, interstitial lung disease).
- •7. Suspected or confirmed untreated, active tuberculosis.
- •8. Severely immune-compromised participants in Investigator’s opinion.
- •9. Recent (within 3 months) active coronary artery disease or decompensated heart failure (New York Heart Association class 3-4).
- •10. Presence of tracheostomy.
- •11. Chronic (=4 weeks) use of corticosteroids >10 mg/day of prednisone or equivalent within 4 weeks of randomization.
- •12. Participation in other clinical investigations utilizing investigational treatment or within 30 days / 5 half-lives whichever is longer.
- •13. Clinically significant abnormalities in clinical chemistry or hematology at screening, defined as:
- •Platelet count <50,000 mm3.
- •Alanine aminotransferase or aspartate aminotransferase >5 × upper limit of normal (ULN).
- •Estimated glomerular filtration rate <30 mL/min/1.73 m2(modification of diet in renal disease formula) or requiring hemofiltration or dialysis.
- •14. Anticipated transfer to another hospital which is not a study site during the treatment period.
- •15. Allergy to any of the components of the study intervention.
研究者
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