EUCTR2020-001052-18-DK进行中（未招募）1 期
A Multicenter, Adaptive, Randomised Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults - Version for European Union/United Kingdom Sites - Adaptive COVID-19 Treatment Trial in the EU & UK (ACTT-EU/UK)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
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. Admitted to a hospital with synmptoms suggestive of COVID-19 infection
- •2. Subject (or legally authorised representative) provides informed consent prior to initiation of any study procedures
- •3. Subject (or legally authorised representative) understands and agrees to comply wiht planned study procedures
- •4.Male or non-pregnant female adult = 18 years of age at time of enrollment
- •5. Has laboratory - confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen as documented by either of the following: PCR positive in sample collected < 72 hours prior to randomisation OR PCR positive in sample collected = 72 hours prior to randomisation, documented inabilty to obtain a repeat sample (e.g. due to lack of testing supplies limited testing capacity, results taking > 24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection
- •6. Illness of any duaration, and at least one of the following:
- •Radiographic infiltrates by imagin (chest X-ray, CT-scanm etc.) OR SpO2 = 94% on room air, OR Requiring supplemental oxygen, OR Requiring mechanical ventilation or ECMO
- •7. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not incluidng hormonal contraception from the time of screening through Day 29
- •8. Agrees to not participate in another clinical trial for treatment of COVID-19 or SARS-CoV-2 thorugh Day 29
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •1. ALT/AST > 5 times the upper limit of normal
- •2. Estimated glumerular filtration rate (eGFR) < 30 ml/min or patientes receiving hemodialysis or hemofiltration at time of screening
- •3. Neutropenia (absolute neutrophil count < 1000 cells/µL) (<1.0 x 103/µL, or <1.0 GI/L)
- •4. Lymphopenia (absolute lymphocyte count <200 cells/µL) (<0.20 x 103/µL or < 0.20 GI/L)
- •5. Pregnancy or breast feeding
- •6. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours
- •7. Allergy to any study medication
- •8. Received three or more doses of remdesivir including the loadingdose, outside of the study under the EUA (or similar mechanism) for COVID-19
- •9. Received convalesent plasma or intravenous immunoglobulin (IVIg]) for COVID-19 the current ilness for which they are being enrolled
- •10. Received small molecule tyrosin kinase inhibitors (e.g. baricitinib, imatibib, genfinitib) in the 1 week prior to screening
- •11. Received monoclonal antibodies targeting cytokines (e.g. TNF inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab]) or cells (e.g. abatacept) im the 4 weeks prior to screening
- •12. Received moniclonal antibodies targeting B-cell (e.g. rituximab and including any targeting multiple cell lines including B-cells) in the 23 month prior to screening
- •13. Received other immunosuppressants in the 4 weeks prior to screening and in the judgement of the investigator, the risk of immunosuppression with baricitinib is larger thatn the risk of COVID-19
- •14. Received = 20 mg/day of prednisolone or equivalent for =14 consecutive days in the 4 weeks prior to screening.
- •15. Use of probenecid that cannot be discontinued at study enrollment.
- •16. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening required).
- •17. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
- •18. Have received any live vaccine (that is, live attenuated) within 4 weeks before screening, or intend to receive a live vaccine (or live attenuated) during the study. Note: Use of non-live (inactivated) vaccinations is allowed for all subjects.
- •19. Have a history of VTE (deep vein thrombosis [DVT] or pulmonary embolism [PE]) within 12 weeks prior to screening or have a history of recurrent (>1) VTE (DVT/PE).
- •20. Immunocompromised patients, patients with a chronic medical condition, or those taking a medication that cannot be discontinued at enrollment, who, in the judgment of PI, are at increased risk for serious infections or other safety concerns given the study products.
研究者
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