Daily Ards Research Analysis

BACKGROUND: Because of the initially urgent need for treatments for COVID-19-associated acute respiratory distress syndrome (ARDS), the efficacy and tolerability of inhaled solnatide, a direct activator of the epithelial sodium channel (ENaC) under clinical investigation for the treatment of ARDS, were assessed in a pilot trial. METHODS: This randomized controlled double-blind clinical trial was performed at two study centers in Vienna, Austria. Adult mechanically ventilated patients with moderate to severe ARDS (Berlin Definition) caused by COVID-19 were randomized 1:1 to inhalation of solnatide (100 mg) or placebo twice daily for seven days. The primary outcome parameter was ventilator-free days (VFDs) within 28 days; survival was assessed at 28 and 60 days as a secondary outcome. RESULTS: A total of 30 out of the 40 planned patients were included, 15 randomized to solnatide and 15 to placebo. Then the trial was stopped early due to slow recruitment. The median VFDs were 0 in both groups (p =  0.653). Twenty out of 30 patients (66.7%) survived until day 28 [solnatide group: n = 11 (73.3%), placebo group: n = 9 (60%)]. One additional patient per group died until day 60. In total, 41 adverse events (AEs) and 10 serious AEs occurred in the solnatide group, and 26 AEs and 14 serious AEs in the placebo group. No AE was considered to be related to the study treatment. CONCLUSIONS: There was no difference in VFDs or survival between the solnatide and the placebo group. Solnatide appeared safe in this limited cohort of critically ill patients with COVID-19. REGISTRATION: EU clinical trials register, EudraCT number 2020-001244-26.

BACKGROUND: A high number of individuals report suffering from physical and psychological sequelae symptoms after COVID-19-the so-called post COVID-19 condition. Commonly reported complaints include physical symptoms such as fatigue, headache, attention and concentration deficits or dyspnea and anxiety, symptoms of post-traumatic stress, or depression. Evidence-based treatment recommendations are still lacking up to this point. Associations between physical and psychological symptoms in chronic diseases are known for a long time. Support in coping with the disease and improvement of self-efficacy can have a positive effect on the course of diseases. For this reason, we designed a randomized, controlled explorative intervention trial as a treatment of bodily distress disorder in COVID-19 recovered persons. METHODS: Patients with a post COVID-19 condition meeting to the criteria of the WHO, along with a bodily distress disorder, are randomized in an intervention and control arm (TAU). Randomization takes place after a diagnostic interview, screening, and informed consent. In total, 60 patients will be included in the trial (30 per group). The intervention group receives a cognitive behavioral therapy as a video-conference-based group therapy (6 weeks) and mobile, respiratory biofeedback treatment (for 4 weeks). At several time points, both groups are assessed in terms of psychological and physical health status, treatment expectation, and satisfaction with the intervention. Furthermore, they will get biofeedback examination appointments. The primary outcome is the change in self-efficacy; secondary outcomes include assessed parameters of mental health, somatic symptoms, and satisfaction with the intervention. Data will be analyzed primarily using R and SPSS. DISCUSSION: The randomized, controlled, explorative intervention trial POSITIV is one of the very first interventions for patients with post COVID-19 condition and psychological burden due to their different symptoms. The aim of the study is to generate new evidence and help patients to cope with the disease and thus, increase their quality of life and reduce symptomatology. We expect with a high probability that the patients' self-efficacy and health status will improve as a result of the intervention. TRIAL REGISTRATION: German Clinical Trial Register (DRKS); DRKS-ID: DRKS00030565. Registered on December 22, 2022.

In the present report, we describe a patient presenting in the intensive care unit with fever, respiratory failure, and multiple lesions on cardiac valves. The patient, with a history of multiple myeloma under treatment, was intubated due to ARDS from influenza, and cardiac ultrasonography revealed lesions in the aortic, mitral, and tricuspid valves. There is a step-by-step approach in the case presentation, with clinical questions, while there is a review of the current literature concerning the issue.