Phase I dose-escalation study of Topotecan in moderate-severe COVID-19 patients - nil

ational University Cancer Institute of Singapore NCIS National University Hospital Singapore0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•SARS-CoV-2 infection confirmed by at least 1 positive PCR test
•Moderate COVID as evidenced by Oxygen saturation <93% on room air (or <88% if prior CLD)
•Admission to emergency department for monitoring and/or supportive care:
•Risk of COVID deterioration, as defined as elevation in any one of:
•CRP > 75mg/L
•D-dimer > 1.0 mg/L
•Ferritin > 500ng/ml
•Elevated IL-6 levels

•Mechanically ventilated/ intubated patients
•The following biochemical markers:
•Absolute neutrophil count (ANC) < 1.5 x 109/L.
•Platelets < 100 x 109/L
•Haemoglobin < 9x 109/L.
•Bilirubin >= 1.5 times upper limit of normal (ULN).
•ALT and AST >= 2.5 times ULN.
•Calculated creatinine clearance of < 30ml/min calculated using the formula of Cockcroft and Gault: (140-age) x mass (kg)/)72x creatinine mg/dl); multiple by 0.85 if female.
•Uncontrolled bacterial, fungal, non-COVID viral infection
•Poorly controlled diabetes mellitus (HbA1c > 8% in the past month)
•Known hypersensitivity to Topotecan
•Use of any other immunosuppressive medication (excluding steroids) administered concurrently or within last 14 days.
•Pregnancy/ breast-feeding
•Enrolment in other therapeutic trial of COVID-19
•Any condition that would, in the opinion of the Investigator, increase the risk of the participant by participating in the study.

发起方

ational University Cancer Institute of Singapore NCIS National University Hospital Singapore