Continuous low dose subcutaneous lidocaine for treatment of the symptoms of COVID*19.   A randomised controlled open*label phase III study.

Phase 3

Withdrawn

• Conditions: ARDS; corona virus; COVID-19; 10024970

• Registration Number: NL-OMON49145
• Lead Sponsor: Julius Clinical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 100

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the clinical improvement of the patients within 5 days after the<br /><br>randomisation in the treatment group compared to the control group.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Reduction of the median time to clinical improvement.<br /><br>• Reduction of the proportion of patients with progression to ARDS in the<br /><br>treatment group compared to the control group.<br /><br>• If applicable, reduction of the length of hospital stay in the treatment<br /><br>group compared to the control group.<br /><br>• If applicable, reduction of the duration of mechanical ventilation and<br /><br>reduction of the length of ICU stay in the treatment group compared to the<br /><br>control group. Case fatality rate at 28 days and 3 months after the admission. </p><br>