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COUNTER-COVID - Oral imatinib to prevent pulmonary vascular leak in Covid19 – a randomized, double --blind, placebo controlled, clinical trial in patients with severe Covid19 disease

Trial Profile

COUNTER-COVID - Oral imatinib to prevent pulmonary vascular leak in Covid19 – a randomized, double --blind, placebo controlled, clinical trial in patients with severe Covid19 disease

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 16 May 2021

At a glance

  • Drugs Imatinib (Primary)
  • Indications COVID-19 respiratory infection; Hypoxia; Respiratory insufficiency
  • Focus Therapeutic Use
  • Acronyms COUNTER-COVID; CounterCovid Study
  • Most Recent Events

    • 23 Feb 2021 Status changed from recruiting to completed.
    • 08 Nov 2020 Planned number of patients changed from 304 to 386.
    • 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

Time to liberation from ventilation and supplemental oxygen >48h while being alive during a 28-day period after randomization

Timepoint: 28 days

Other Endpoints

- Secondary efficacy parameters o 28-day mortality o Need for ICU admission o Length of ICU admission o Need for invasive ventilation o Length of invasive ventilation o Days on ventilator o Need for ECMO o Need for non-invasive ventilation o Length of non-invasive ventilation o SpO2 at Day 1,2,3,4,5,7,9 o Fi O2 at Day 1,2,3,4,5,7,9 o SpO2/FiO2 at Day 1,2,3,4,5,7,9 - Safety parameters o Blood cell count Day 0,1,2,3,5,7,9 o Kidney function Day 0,1,2,3,5,7,9 o Liver enzymes Day 0,1,2,3,5,7,9 o NTproBNP at Day 0,1,2,3,5,7,9 o SAEs / AE o ECG at Day 1,3,5,9 - Pharmacokinetics o Study drug plasma levels at 4h, 8h, Day 1,3,5,7,9 o Albumin, AGP1 at Day 0,1,2,3,5,7,9 - Immune responses (subgroups of 50 patients per study arm) o Host response plasma biomarkers on day 0, 5 and 9, and on the first day of any additional interventions (invasive ventilation, CT scanning, bronchoscopy). o Neutrophil RNA sequencing, metabolomics and lipidomics on day 0 and 5 o Phenotypic and functional analysis of whole blood, peripheral blood mononuclear cells and polymorphonuclear leukocytes on day 0 and 5, and on the first day of additional interventions (invasive ventilation, CT scanning, bronchoscopy). - Fibrotic responses (subgroups of 50 patients per study arm) o Fibrotic plasma biomarkers on day 0, 5 and 9, and on the first day of any additional interventions (invasive ventilation, CT scanning, bronchoscopy) Timepoint: 28 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID-19 respiratory infection treatment severe
Hypoxia treatment -
Respiratory insufficiency treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 386

  • Sex male & female
  • Age Group ≥ 18 years; adult; elderly

Patient Inclusion Criteria

- Age >18 years- Hospital admission with proven SARS2-Covid19 infection- Hypoxemic respiratory failure (SaO2 <94%, PaO2 <9kPa)- 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- Chronic home oxygen treatment- Pre-existing heart failure with a known left ventricular ejection fraction <40%- Active treatment of hematological or non-hematological cancer with targeted, immuno- or chemotherapy or targeted radiotherpay in the last year- 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 >5 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- Use of strong Cyp3A4 inductors, including the following drugs: Carbamazepine, efavirenz, enzalutamide, fenobarbital, fenytoine, hypericum, mitotaan, nevirapine, primidon, rifabutine, rifampicine- Concomittant use of chloroquine or hydroxychloroquine.- QTc >500msec at baseline.

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 Sep 2020

    Actual : 01 Feb 2021

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • 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
16 May 2021 Other trial event Last checked against European Clinical Trials Database record. Updated 16 May 2021
23 Feb 2021 Status change - completed Status changed from recruiting to completed. Updated 23 Feb 2021
08 Nov 2020 Other trial event Planned number of patients changed from 304 to 386. Updated 09 Nov 2020
03 Apr 2020 New trial record New trial record Updated 03 Apr 2020

References

  1. European Clinical Trials Database. Trial-Reg 2021;.

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