Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Topotecan
Dexamethasone
Remdesivir: Tab. Topotecan 0.25mg single dose on D2 of admission given orally.
Tab. Dexamethasone 6mg OD D1-10 of admission, given orally.
Tab. Remdesivir 100m
Sponsors
National University Cancer Institute of Singapore NCIS National University Hospital Singapore
Eligibility
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Topotecan AUC of less than 15000nM-min (or CMax of 100nM) 2. neutropeniaTimepoint: 1. Topotecan levels at pre-treatment 1 hour and 24 hours. 2.blood counts - 2x/ week (D3, D7, D10 and D14) | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose Limiting Toxicity (DLT)- rate of treatment related treatment related toxicity (grade 2, 3 or 4)Timepoint: 30 days from therapeutic intervention | — |
Countries
India
Contacts
Public ContactDr Ajoy Oommen John
Christian Medical College, Vellore
Outcome results
None listed