Phase I-II study of Topotecan combined with Dexamethasone and Remdesivir to reduce systemic inflammation in cancer patients with COVID-19 - TopVid1

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

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•1) with current or past history of cancer
•2) SARS-CoV-2 infection confirmed by at least 1 positive PCR test
•3) Admission to hospital for monitoring and/or supportive care
•4) Absolute neutrophil count (ANC) >= 1.5 x 109/L. Platelets >= 75 x 109/L, Haemoglobin >= 9x 109/L.
•5) Bilirubin < 1.5 times upper limit of normal (ULN). ALT and AST < 2.5 times ULN.
•6) 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.
•7) Able to comply with study related procedures and able to provide informed consent

•1) Severe COVID; as defined by the requirement for ICU care.
•2) Any immunosuppressive medication (excluding steroids) administered concurrently or within last 15 days.
•3) Pregnancy or Breastfeeding.
•4) Known allergy to Topotecan. Unconjugated hyperbilirubinemia on a fasting LFT, which can indicate Gilberts Syndrome.
•5) Suspected active bacterial, fungal, or other infection in addition to COVID-19.
•6) Any condition that would, in the opinion of the Investigator, increase the risk of the participant by participating in the study.
•7) Inability to provide consent or unable to comply with study procedures

发起方

ational University Cancer Institute of Singapore NCIS National University Hospital Singapore