Senicapoc treatment of COVID-19 positive patients in intensive care

Phase 1

• Conditions: Infection with COVID19; MedDRA version: 21.1Level: PTClassification code 10001052Term: Acute respiratory distress syndromeSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001420-34-DK
• Lead Sponsor: Aarhus University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-01
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1) COVID-19
2) Age =18 years
3) Respiratory insufficiency
4) ICU admission

COVID-19 will be defined as a positive polymerase chain reaction (PCR)
test for SARS-CoV-2, either from a nasal or throat swab or from tracheal
suctioning, within the last 14 days prior to ICU admission. Respiratory
insufficiency will be defined as a need for supplemental oxygen of at
least 10 L/min in patients without a need for mechanical ventilation or
invasive or non-invasive mechanical ventilation with a FiO2 = 40%. An
ICU will be defined per local practices.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 23
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23

Exclusion Criteria

1) Severe heart failure (ejection fraction < 30%)
2) Severe renal insufficiency (eGFR < 30 mL/min/1.73m2)
3) Severe hemodynamic instability (noradrenalin dose > 0.3 µg/kg/min)
4) Prior enrollment in the trial
5) Pregnancy
6) Allergy to senicapoc
7) Inability to take enteral medication
8) More than 24 hours since ICU admission
9) Limitations of care
10) Anticipated death within 24 hours
Severe heart failure will pragmatically be defined solely on the basis of
the latest measured or estimated ejection fraction obtained via
echocardiography (or other image modalities). If no ejection fraction is
available, it will be assumed that the patient does not have severe heart
failure. Renal insufficiency will be defined based on the latest estimated
glomerular filtration rate (eGFR). If a patient is receiving renal
replacement therapy, this will likewise be considered severe renal
insufficiency. Hemodynamic instability will be defined based on a need
for high-dose continuous vasopressor therapy specifically a noradrenalin
dose > 0.3 µg/kg/min. If the patient is receiving other vasopressors
instead of or in addition to noradrenalin, a noradrenaline-equivalent
dose will be estimated based on prior formulas.39 In fertile women (age
< 50 years) a negative urine-hCG or plasma-hCG must be present before
enrolment. In order to optimize the chances of patients surviving to 72
hours (the time of the primary outcome), patients with limitations of
care (including limitations related to mechanical ventilation and renal
replacement therapy but not cardiopulmonary resuscitation) and
patients with anticipated death within 24 hours, as judged by the
treating clinician, will be excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified