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

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 - CounterCovid Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49996

Enrollment

386

Registered

2020-03-25

Start date

2020-03-31

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

COVID-19 disease Pulmonary edema

Interventions

Intervention: The intervention group will receive a starting dose of 800mg oral imatinib once daily, followed by 400mg once daily during 9 days. The control group will receive a similar dosing sched

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >18 years - Hospital admission with proven SARS2-Covid19 infection - Hypoxemic respiratory failure (SpaO2

Exclusion criteria

Exclusion criteria: - Pre-existing chronic pulmonary disease - Former diagnosis of Interstitial pulmonary disease - Former diagnosis of COPD 4 or FEV15 x ULN (upper limit of normal) or bilirubin > 1.5 x ULN - History or suspicion of inability to cooperate adequately. - White blood count 500msec at baseline.

Design outcomes

Primary

Measure	Time frame
The main study parameter is the time to liberation from ventilation and supplemental oxygen and alive during a 28 day period after randomization	—

Secondary

Measure	Time frame
- Secondary efficacy parameters 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 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 o Length of oxygen suppletion - 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)	—

Measure

Time frame

- Secondary efficacy parameters 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 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 o Length of oxygen suppletion - 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)

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)