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COUNTER-COVID - Oral imatinib to prevent pulmonary vascular leak in COVID-19 – a randomized, single-blind, placebo controlled, clinical trial in patients with severe COVID-19 disease

Trial Profile

COUNTER-COVID - Oral imatinib to prevent pulmonary vascular leak in COVID-19 – a randomized, single-blind, placebo controlled, clinical trial in patients with severe COVID-19 disease

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 03 Apr 2020

At a glance

  • Drugs Imatinib (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Acronyms COUNTER-COVID; CounterCovid Study
  • Most Recent Events

    • 03 Apr 2020 New trial record

Trial Overview

Purpose

To test whether treatment with oral imatinib reduce disease burden and consumption of medical resources.

Primary Endpoints

Composite outcome of death / need for invasive ventilation / need for ECMO
Timepoint: 28 days

Other Endpoints

o 28-day mortality
o Need for ICU admission
o Length of ICU admission
o Need for invasive ventilation
o Days on ventilator
o Need for ECMO
o Need for non-invasive ventilation
o Pa/FiO2 ratio and Oxygenation index at Day 1,2,3,4,5,8,10
o SaO2 at Day 1,2,3,4,5,8,10
o Supplemental O2 at Day 1,2,3,4,5,8,10
o Viral clearance at Day 5 and 10.
- Safety parameters
o Blood cell count Day 0,1,2,3,5,10
o Kidney function Day 0,1,2,3,5,10
o Liver enzymes Day 0,1,2,3,5,10
o NTproBNP at Day 0,1,2,3,5,10
o SAEs / AE
o ECG at Day 1,3,5,10
- Pharmacokinetics
o Study drug plasma levels at 4h, 8h, Day 1,3,5,10
o Albumin, AGP1
Timepoint: 28 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 304

  • Sex male & female
  • Age Group adult; elderly

Patient Inclusion Criteria

- Age >18 years - Hospital admission with proven SARS2-Covid19 infection - Hypoxemic respiratory failure (SaO2 <92%, PaO2 <8kPa) - Ability to give informed consent.

Patient Exclusion Criteria

- Pre-existing chronic pulmonary disease - Former diagnosis of Interstitial pulmonary disease - Former diagnosis of COPD 4 or FEV1<30%pred - Previous DLCO <45% - Total lung capacity (TLC) < 60% of predicted - Lung cancer with non-surgical treatment in last year - Home oxygen treatment - Active treatment of hematological or non-hematological cancer with targeted, immuno- or chemotherapy in the last year - Chronic or acute renal failure, defined as eGFR <30ml/min - Inability to provide informed consent - Any subject who had received any investigational medication within 1 month prior to the start of this study or who is scheduled to receive another investigational drug during the course of this study - Active liver disease, porphyria or elevations of serums transaminases >3 x ULN (upper limit of normal) or bilirubin > 1.5 x ULN - History or suspicion of inability to cooperate adequately. - White blood count < 4.0^109/l - Hemoglobin < 6.0 mmol/l - Thrombocytes < 100^109/l - Pregnant female subjects - Breastfeeding female subjects

Trial Details

Identifiers

Identifier Owner
EudraCT2020-001236-10 European Clinical Trials Database
COVID19 -

Trial Dates

  • Initiation Dates

    Actual : 31 Mar 2020

  • End Dates

    Planned : 30 Jun 2020

Other Details

  • Design multicentre; prospective; randomised; single-blind
  • Phase of Trial Phase II
  • Location Netherlands
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
ImatinibPrimary Drug Oral Tablet

Product Name: Imatinib mesilate
Investigational Medicinal Product Trade Name: Imatinib mesilate
Name of the Marketing Authorisation Holder: Novartis
Country which granted the Marketing Authorisation: Netherlands
Investigational Medicinal Product Code: L01XE01
Pharmaceutical Form: Tablet
IMP Routes of Administration: Oral use
Chemical Origin Active Substance: yes

Number Of treatment arms In the trial: 2

Is placebo used in this trial?: yes

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Jurjan Aman
De Boelelaan 1117
Amsterdam
Postcode: 1081 HV
Netherlands
Telephone: +31610738910
j.aman@amsterdamumc.nl
show details
Amsterdam UMC Netherlands

Centres

Centre Name Location Trial Centre Country
Amsterdam UMC Amsterdam Netherlands

Trial History

Event Date Event Type Comment
03 Apr 2020 New trial record New trial record Updated 03 Apr 2020

References

  1. European Clinical Trials Database. Trial-Reg 2016;.

    Available from: URL: https://www.clinicaltrialsregister.eu
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