|D053120||Respiratory Aspiration NIH||0.50|
|D011024||Pneumonia, Viral NIH||0.14|
There is one clinical trial.
This single-center, prospective, open-label, comparator study, blind for central accessor evaluates the efficacy, safety of inhalations of low-doses of melphalan in patients with pneumonia with confirmed or suspected COVID-19. All patients will receive 0,1 mg of melphalan in 7-10 daily inhalations 1 time per day.
Description: The number of patients with the clinical improvement is defined as an improvement of two points (from the status at baseline) on an ordinal scale of clinical improvement on day 28 or discharge from hospital ( whatever occurs earlier) Death Hospitalized with Invasive mechanical ventilation plus additional organ support - ECMO / pressors / RRT Hospitalized with intubation and mechanical ventilation Hospitalized on non-invasive ventilation or high flow oxygen. Hospitalized on a mask or nasal prongs. Hospitalized no oxygen therapy. Ambulatory, with limitation of activities. Ambulatory, no limitation of activities. I. No clinical or virological evidence of infection.Measure: The changes of COVID Ordinal Outcomes Scale Time: baseline vs Day 14, day 28
Description: Percentage of the patients with clinical recovery which is defined as a normalisation of fever, respiratory rate, and oxygen saturation, and improvement of cough, sustained for at least 72 hours, or live hospital discharge, whichever comes first. Normalization and improvement criteria: Fever - <37°C, Respiratory rate - ≤24/minute on room air, Oxygen saturation - >94% on room air, Cough - mild or absent on a patient reported scale of severe, moderate, mild, absent.Measure: Percentage of the patients with Clinical Recovery Time: baseline vs day 7, day 14, day 28
Description: The evaluation of changes in modified Borg dyspnea scale. From 0 to 10 units.A lower score means a better clinical result (0 is the absence of dyspnea, and 10 - is maximal dyspnea). Minimal clinically important difference is 1 unit.Measure: The changes of the Borg's scale Time: Baseline vs day 7, day 14, day 28
Description: Change in C-reactive protein (CRP) level from baseline in mg/ml. A lower level of CRP means a better clinical result.Measure: CRP level Time: baseline, day 7, Day 14, Day 28
Description: Change in blood absolute lymphocyte count from baseline. A higher number of lymphocytes means a better clinical result.Measure: Lymphocyte count Time: baseline, day 7, Day 14, Day 28
Description: Change in blood D-dimer level from baseline. A lower level of D-dimer means a better clinical result.Measure: D-dimer Time: baseline, day 7, Day 14, Day 28
Description: Change in peripheral blood IL-6 level from baseline. A lower level of IL-6 means a better clinical result.Measure: IL-6 Time: baseline, day 7, Day 14, Day 28
Description: Percentage of patients without artificial lung ventilation during the study. A lower percentage of patients means a better clinical result.Measure: Percentage of patients without artificial lung ventilation Time: baseline, day 7, Day 14, Day 28