ARDS corona virus COVID-19
Conditions
Interventions
The IMP used in this study is lidocaine. Lidocaine will be administered as a
subcutaneous loading dose of 1 mg/kg, followed by a continuous subcutaneous
lidocaine infusion of 1 mg/kg/hr. Treatment d
Sponsors
Julius Clinical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Each patient (or the patient*s legally authorized representatives) must sign an informed consent form (ICF) indicating that they understand the purpose of and procedures required for this study, are willing to participate in the study and attend all scheduled visits, and are willing and able to comply with all study-related procedures, and adhere to the prohibitions and restrictions as specified in the protocol. 2. Age >=18 years. 3. Acute disease with a positive test for COVID-19. 4. Patients with symptoms of COVID-19 admitted to the ICU, the hospital ward or residing in a nursing home are eligible for inclusion in the study. Should a patient with spontaneous breathing deteriorate requiring mechanical ventilation after the inclusion the patient will remain in the study.
Exclusion criteria
Exclusion criteria: 1. Patients known with allergy or hypersensitivity to lidocaine, xylocaine or lignocaine. 2. Patients with severe hypoalbuminaemia (decreased drug-protein binding), 3. Patients with potentially reduced elimination speed of lidocaine: a. Severe liver and kidney dysfunction b. Use of certain medications: erythromycin, beta-blockers, ciprofloxacin, cimetidine, clonidine, amiodarone or phenytoin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the clinical improvement of the patients within 5 days after the randomisation in the treatment group compared to the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Reduction of the median time to clinical improvement. • Reduction of the proportion of patients with progression to ARDS in the treatment group compared to the control group. • If applicable, reduction of the length of hospital stay in the treatment group compared to the control group. • If applicable, reduction of the duration of mechanical ventilation and reduction of the length of ICU stay in the treatment group compared to the control group. Case fatality rate at 28 days and 3 months after the admission. | — |
Countries
Netherlands
Outcome results
None listed