ISRCTN11188345已完成4 期
mulTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19 – Repurposed Drugs (TACTIC-R)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 417
研究概览
简要总结
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32641154/ protocol (added 10/07/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37977159/ (added 05/03/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Be aged 18 years and over
- •2. Have clinical picture strongly suggestive of COVID-19-related disease (with/without positive COVID-19 test) AND
- •2.1. Risk count (as defined above) >3 OR
- •2.3. Risk count 3 if risk count includes Radiographic severity score >3”
- •3. Be considered an appropriate subject for intervention with immunomodulatory in the opinion of the investigator
- •4. Be able to be maintained on venous thromboembolism prophylaxis or current maintenance therapy during inpatient dosing period, according to local guidelines
排除标准
- •1. Inability to supply direct informed consent from patient or from Next of Kin or Independent Healthcare Provider on behalf of patient
- •2. Mechanical ventilation at time of prior to dosing
- •3. Contraindications to study drugs, including hypersensitivity to the active substances or any of the excipients
- •4. Currently on any of the study investigational medicinal products
- •5. Known unresolved Neisseria meningitidis infection
- •6. Unwilling to be vaccinated against Neisseria meningitidis or receive prophylactic antibiotic cover until 2 weeks after vaccination
- •7. Known active tuberculosis (no blood screening required)
- •8. Known active Hepatitis B or C (no blood screening required); active varicella zoster.
- •9. Concurrent participation in any interventional clinical trial including COVID-19-related disease trials (observational studies allowed)
- •10. Patient moribund at presentation or screening
- •11. Pregnancy at screening (or unwillingness to adhere to pregnancy advice in protocol)
- •12. Unwillingness to adhere to breastfeeding advice in protocol.
- •13. Either alanine transaminase or aspartate transaminase (ALT or AST) > 5 times the upper limit of normal
- •14. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. Cockcroft Gault estimated creatinine clearance < 30 ml /min/1.73 m2)
- •15. Currently receiving probenecid or chronic IVIG treatment
- •16. Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern
研究者
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