Senicapoc treatment in COVID-19 Patients with Severe Respiratory Insufficiency - A Randomized, Open-Label, Phase II Trial

Asger Granfeldt; Lars W Andersen; Mikael F Vallentin; Ole Hilberg; Jørgen B Hasselstrøm; Lambert K Sørensen; Susie Mogensen; Steffen Christensen; Anders M Grejs; Bodil S Rasmussen; Klaus T Kristiansen; Thomas Strøm; Isik S Johansen; Olav L Schjørring; Ulf Simonsen

doi:10.1111/aas.14072

Senicapoc treatment in COVID-19 Patients with Severe Respiratory Insufficiency - A Randomized, Open-Label, Phase II Trial

Asger Granfeldt, Lars W Andersen, Mikael F Vallentin, Ole Hilberg, Jørgen B Hasselstrøm, Lambert K Sørensen, Susie Mogensen, Steffen Christensen, Anders M Grejs, Bodil S Rasmussen, Klaus T Kristiansen, Thomas Strøm, Isik S Johansen, Olav L Schjørring, Ulf Simonsen

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

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Abstract

BACKGROUND: The aim of the current study was to determine if treatment with senicapoc, improves the PaO 2 /FiO 2 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 PaO 2 /FiO 2 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, PaO 2 /FiO 2 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 PaO 2 /FiO 2 ratio at 72 h with no differences for other outcomes.

Originalsprog	Engelsk
Tidsskrift	Acta Anaesthesiologica Scandinavica
Vol/bind	66
Udgave nummer	7
Sider (fra-til)	838-846
Antal sider	9
ISSN	0001-5172
DOI	https://doi.org/10.1111/aas.14072
Status	Udgivet - aug. 2022

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10.1111/aas.14072Licens: CC BY 4.0

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Granfeldt, A., Andersen, L. W., Vallentin, M. F., Hilberg, O., Hasselstrøm, J. B., Sørensen, L. K., Mogensen, S., Christensen, S., Grejs, A. M., Rasmussen, B. S., Kristiansen, K. T., Strøm, T., Johansen, I. S., Schjørring, O. L., & Simonsen, U. (2022). Senicapoc treatment in COVID-19 Patients with Severe Respiratory Insufficiency - A Randomized, Open-Label, Phase II Trial. Acta Anaesthesiologica Scandinavica, 66(7), 838-846. https://doi.org/10.1111/aas.14072

@article{ce91a3d0e2fc483287c910bacca0fb80,

title = "Senicapoc treatment in COVID-19 Patients with Severe Respiratory Insufficiency - A Randomized, Open-Label, Phase II Trial",

abstract = "BACKGROUND: The aim of the current study was to determine if treatment with senicapoc, improves the PaO 2 /FiO 2 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 PaO 2 /FiO 2 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, PaO 2 /FiO 2 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 PaO 2 /FiO 2 ratio at 72 h with no differences for other outcomes. ",

keywords = "ARDS, COVID-19, SARS-CoV-2, Senicapoc, respiratory insufficiency, Humans, Adolescent, Adult, Trityl Compounds, Acetamides, Respiration, Artificial, Respiratory Insufficiency/therapy",

author = "Asger Granfeldt and Andersen, {Lars W} and Vallentin, {Mikael F} and Ole Hilberg and Hasselstr{\o}m, {J{\o}rgen B} and S{\o}rensen, {Lambert K} and Susie Mogensen and Steffen Christensen and Grejs, {Anders M} and Rasmussen, {Bodil S} and Kristiansen, {Klaus T} and Thomas Str{\o}m and Johansen, {Isik S} and Schj{\o}rring, {Olav L} and Ulf Simonsen",

note = "{\textcopyright} 2022 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.",

year = "2022",

month = aug,

doi = "10.1111/aas.14072",

language = "English",

volume = "66",

pages = "838--846",

journal = "Acta Anaesthesiologica Scandinavica",

issn = "0001-5172",

publisher = "Wiley-Blackwell",

number = "7",

}

Granfeldt, A, Andersen, LW, Vallentin, MF, Hilberg, O, Hasselstrøm, JB, Sørensen, LK, Mogensen, S, Christensen, S, Grejs, AM, Rasmussen, BS, Kristiansen, KT, Strøm, T, Johansen, IS, Schjørring, OL & Simonsen, U 2022, 'Senicapoc treatment in COVID-19 Patients with Severe Respiratory Insufficiency - A Randomized, Open-Label, Phase II Trial', Acta Anaesthesiologica Scandinavica, bind 66, nr. 7, s. 838-846. https://doi.org/10.1111/aas.14072

TY - JOUR

T1 - Senicapoc treatment in COVID-19 Patients with Severe Respiratory Insufficiency - A Randomized, Open-Label, Phase II Trial

AU - Granfeldt, Asger

AU - Andersen, Lars W

AU - Vallentin, Mikael F

AU - Hilberg, Ole

AU - Hasselstrøm, Jørgen B

AU - Sørensen, Lambert K

AU - Mogensen, Susie

AU - Christensen, Steffen

AU - Grejs, Anders M

AU - Rasmussen, Bodil S

AU - Kristiansen, Klaus T

AU - Strøm, Thomas

AU - Johansen, Isik S

AU - Schjørring, Olav L

AU - Simonsen, Ulf

PY - 2022/8

Y1 - 2022/8

N2 - BACKGROUND: The aim of the current study was to determine if treatment with senicapoc, improves the PaO 2 /FiO 2 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 PaO 2 /FiO 2 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, PaO 2 /FiO 2 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 PaO 2 /FiO 2 ratio at 72 h with no differences for other outcomes.

AB - BACKGROUND: The aim of the current study was to determine if treatment with senicapoc, improves the PaO 2 /FiO 2 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 PaO 2 /FiO 2 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, PaO 2 /FiO 2 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 PaO 2 /FiO 2 ratio at 72 h with no differences for other outcomes.

KW - ARDS

KW - COVID-19

KW - SARS-CoV-2

KW - Senicapoc

KW - respiratory insufficiency

KW - Humans

KW - Adolescent

KW - Adult

KW - Trityl Compounds

KW - Acetamides

KW - Respiration, Artificial

KW - Respiratory Insufficiency/therapy

UR - http://www.scopus.com/inward/record.url?scp=85132616375&partnerID=8YFLogxK

U2 - 10.1111/aas.14072

DO - 10.1111/aas.14072

M3 - Journal article

C2 - 35403225

SN - 0001-5172

VL - 66

SP - 838

EP - 846

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

IS - 7

ER -

Senicapoc treatment in COVID-19 Patients with Severe Respiratory Insufficiency - A Randomized, Open-Label, Phase II Trial

Abstract

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