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Clinical Trial
. 2022 Aug;66(7):838-846.
doi: 10.1111/aas.14072. Epub 2022 May 13.

Senicapoc treatment in COVID-19 patients with severe respiratory insufficiency-A randomized, open-label, phase II trial

Asger Granfeldt  1   2 , Lars W Andersen  1   2   3   4 , Mikael F Vallentin  2   3 , Ole Hilberg  5 , Jørgen B Hasselstrøm  6 , Lambert K Sørensen  6 , Susie Mogensen  7 , Steffen Christensen  1   2 , Anders M Grejs  1   2 , Bodil S Rasmussen  8   9 , Klaus T Kristiansen  10 , Thomas Strøm  11   12 , Isik S Johansen  13 , Olav L Schjørring  8   9 , Ulf Simonsen  7
Affiliations
Clinical Trial

Senicapoc treatment in COVID-19 patients with severe respiratory insufficiency-A randomized, open-label, phase II trial

Asger Granfeldt et al. Acta Anaesthesiol Scand. 2022 Aug.

Abstract

Background: The aim of the current study was to determine if treatment with senicapoc, improves the PaO2 /FiO2 ratio in patients with COVID-19 and severe respiratory insufficiency.

Methods: Investigator-initiated, randomized, open-label, phase II trial in four intensive care units (ICU) in Denmark. We included patients aged ≥18 years and admitted to an ICU with severe respiratory insufficiency due to COVID-19. The intervention consisted of 50 mg enteral senicapoc administered as soon as possible after randomization and again after 24 h. Patients in the control group received standard care only. The primary outcome was the PaO2 /FiO2 ratio at 72 h.

Results: Twenty patients were randomized to senicapoc and 26 patients to standard care. Important differences existed in patient characteristics at baseline, including more patients being on non-invasive/invasive ventilation in the control group (54% vs. 35%). The median senicapoc concentration at 72 h was 62.1 ng/ml (IQR 46.7-71.2). The primary outcome, PaO2 /FiO2 ratio at 72 h, was significantly lower in the senicapoc group (mean 19.5 kPa, SD 6.6) than in the control group (mean 24.4 kPa, SD 9.2) (mean difference -5.1 kPa [95% CI -10.2, -0.04] p = .05). The 28-day mortality in the senicapoc group was 2/20 (10%) compared with 6/26 (23%) in the control group (OR 0.36 95% CI 0.06-2.07, p = .26).

Conclusions: Treatment with senicapoc resulted in a significantly lower PaO2 /FiO2 ratio at 72 h with no differences for other outcomes.

Keywords: ARDS; COVID-19; SARS-CoV-2; Senicapoc; respiratory insufficiency.

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Figures

FIGURE 1
FIGURE 1
Participant Flow. Randomization was stratified by site and baseline PaO2/FiO2 ratio (above or below mmHg 20 kPa). No patient was lost to follow‐up. *Renal transplant patients, renal consultant worried about potential interactions with immunosuppressant. #Admitted for other diseases than COVID‐19
FIGURE 2
FIGURE 2
Senicapoc plasma concentrations from baseline to day 7 in the intervention group (n = 20). One patient had missing samples at day 7
FIGURE 3
FIGURE 3
Mean PaO2/FiO2 ratio from baseline to day 10 in the two groups. All patients with a missing PaO2/FiO2 ratio from day 8 and forward were discharged home, except for one patient in the standard care group dying at day 8. Error bars SD
See this image and copyright information in PMC

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