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Senicapoc treatment in COVID-19 patients with severe respiratory insufficiency-A randomized, open-label, phase II trial.
Granfeldt, Asger; Andersen, Lars W; Vallentin, Mikael F; Hilberg, Ole; Hasselstrøm, Jørgen B; Sørensen, Lambert K; Mogensen, Susie; Christensen, Steffen; Grejs, Anders M; Rasmussen, Bodil S; Kristiansen, Klaus T; Strøm, Thomas; Johansen, Isik S; Schjørring, Olav L; Simonsen, Ulf.
  • Granfeldt A; Department of Anesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.
  • Andersen LW; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
  • Vallentin MF; Department of Anesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.
  • Hilberg O; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
  • Hasselstrøm JB; Prehospital Emergency Medical Services, Central Denmark Region, Denmark.
  • Sørensen LK; Research Center for Emergency Medicine, Aarhus University Hospital, Aarhus, Denmark.
  • Mogensen S; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
  • Christensen S; Prehospital Emergency Medical Services, Central Denmark Region, Denmark.
  • Grejs AM; Department of Medicine, Vejle Hospital, Vejle, Denmark.
  • Rasmussen BS; Section for Forensic Chemistry, Department of Forensic Medicine, Aarhus University, Aarhus, Denmark.
  • Kristiansen KT; Section for Forensic Chemistry, Department of Forensic Medicine, Aarhus University, Aarhus, Denmark.
  • Strøm T; Department of Biomedicine, Pulmonary and Cardiovascular Pharmacology, Aarhus University, Aarhus, Denmark.
  • Johansen IS; Department of Anesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.
  • Schjørring OL; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
  • Simonsen U; Department of Anesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.
Acta Anaesthesiol Scand ; 66(7): 838-846, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1784567
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiratory Insufficiency / COVID-19 Type of study: Controlled clinical trial / Observational study / Randomized controlled trials Limits: Adolescent / Adult / Humans Language: English Journal: Acta Anaesthesiol Scand Year: 2022 Document Type: Article Affiliation country: Aas.14072

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiratory Insufficiency / COVID-19 Type of study: Controlled clinical trial / Observational study / Randomized controlled trials Limits: Adolescent / Adult / Humans Language: English Journal: Acta Anaesthesiol Scand Year: 2022 Document Type: Article Affiliation country: Aas.14072