CTRI/2021/05/033546招募中2 期
Multi-Arm Therapeutic Study in Pre-ICU Patients Admitted With Covid-19 â?? Experimental Drugs and Mechanisms - TACTIC-E
试验速览
- 阶段
- 2 期
- 状态
- 招募中
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
入选标准
- •Have clinical picture strongly suggestive of COVID-19-related disease (with/without positive COVID-19 test) AND
- •-Risk count (as defined above) >3
- •-Risk count ï?³3 if it includes â??Radiographic severity score >3â??
- •Be considered an appropriate subject for intervention with immunomodulatory or other disease modifying agents in the opinion of the investigator
- •Is able to swallow capsules/tablets
- •Risk count (score 1 point for each of the following):
- •Radiographic severity score >3
- •Male gender
- •Non-white ethnicity
- •Hypertension
- •Neutrophils >8.0 x109/L
- •Age >40 years
- •CRP >40 mgl/
排除标准
- •General exclusion criteria
- •The presence of any of the following will preclude participant inclusion:
- •Inability to supply direct informed consent from patient or from Next of Kin or Independent Healthcare Provider on behalf of patient
- •Invasive mechanical ventilation at time of screening
- •Contraindications to study drugs, including hypersensitivity to the active substances or any of the excipients
- •Currently on any of the study investigational medicinal products
- •Concurrent participation in an interventional clinical trial (observational studies allowed)
- •Patient moribund at presentation or screening
- •Pregnancy at screening
- •Unwilling to stop breastfeeding during treatment period
- •Known severe hepatic impairment (with or without cirrhosis)
- •Stage 4 severe chronic kidney disease or requiring dialysis (i.e. Cockcroft Gault estimated creatinine clearance < 30 ml /min)
- •Inability to swallow at screening visit
- •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.
- •Drug specific exclusion criteria
- •EDP1815 Specific Exclusions
- •Patient is taking a systemic immunosuppressive agent such as, but not limited to, oral steroids, methotrexate, azathioprine, ciclosporin or tacrolimus, unless these are given as part of COVID standard of care treatment.
- •Dapagliflozin and Ambrisentan Specific Exclusions
- •Type 1 diabetes
- •Known idiopathic pulmonary fibrosis
- •Previous hospital admission with ketoacidosis
- •History of symptomatic heart failure within 3 months of admission
- •Sustained blood pressure below 90/60 mmHg at admission
- •Metabolic acidosis defined as venous pH < 7.3 (or venous bicarbonate <15 mmol/l) AND ketones > 3.0 mmol/L
- •Alanine transaminase and/or aspartate transaminase (ALT and/or AST) > 3 times the upper limit of normal (only one needs to be measured)
研究者
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