Reducing hypoxia in patients with COVID-19 using Topotecan with standard of care

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/08/035537

Enrollment

Registered

2021-08-09

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Topotecan Dexamethasone Remdesivir: The drugs will be administered as follows: Inj. Topotecan 0.25mg IV in 100ml Normal saline over 30 minutes given as a single dose on D2 of admission.

Eligibility

Inclusion criteria

Inclusion criteria: SARS-CoV-2 infection confirmed by at least 1 positive PCR test Moderate COVID as evidenced by Oxygen saturation 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 LDH > ULN D-dimer > 1.0 mg/L Ferritin > 500ng/ml Elevated IL-6 levels

Exclusion criteria

Exclusion criteria: Mechanically ventilated/ intubated patients The following biochemical markers: Absolute neutrophil count (ANC) Platelets Haemoglobin Bilirubin = 1.5 times upper limit of normal (ULN). ALT and AST = 2.5 times ULN. Calculated creatinine clearance of 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.

Design outcomes

Primary

Measure	Time frame
To determine a maximal dose, out of 4 pre-specified dosing levels of Topotecan, at which less than 1 out of 3 patients exhibit anti-cancer concentrations in plasma (defined as AUC 150000/CMax1000), or have G2/3/4 neutropeniaTimepoint: To determine a maximal dose, out of 4 pre-specified dosing levels of Topotecan, at which less than 1 out of 3 patients exhibit anti-cancer concentrations in plasma (defined as AUC 150000/CMax1000), or have G2/3/4 neutropenia	—

Measure

Time frame

To determine a maximal dose, out of 4 pre-specified dosing levels of Topotecan, at which less than 1 out of 3 patients exhibit anti-cancer concentrations in plasma (defined as AUC 150000/CMax1000), or have G2/3/4 neutropeniaTimepoint: To determine a maximal dose, out of 4 pre-specified dosing levels of Topotecan, at which less than 1 out of 3 patients exhibit anti-cancer concentrations in plasma (defined as AUC 150000/CMax1000), or have G2/3/4 neutropenia

—

Secondary

Measure	Time frame
Determine effect of Topotecan on duration of additional oxygen requirementsTimepoint: from day of intervention to day of removal of supplimental oxygen.	—

Countries

India

Contacts

Public ContactDr Ajoy Oommen John

Christian Medical College,

ajoyoommenjohn@gmail.com7639195315

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026