Reducing systemic inflammation in cancer patients with COVID-19 using Topotecan with Dexamethasone and Remdesivir

Phase 1

Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: C00-D49- Neoplasms

Registration Number: CTRI/2021/03/031969

Lead Sponsor: ational University Cancer Institute of Singapore NCIS National University Hospital Singapore

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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 < 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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br/ ><br>2.blood counts - 2x/ week (D3, D7, D10 and D14) <br/ ><br>

Secondary Outcome Measures