The current study will investigate the tolerability and efficacy of inhaled Carragelose® versus saline in hospitalized COVID-19 patients. As SARS-CoV-2 replicates readily in the lung, it is planed to apply Carragelose® in an inhalative form. Hospitalized COVID-19 patients with respiratory symptoms will inhale Inhaleen for 5 days.
The tolerability and efficacy of inhaled Carragelose® will be investigated in a randomized, double blind, placebo-controlled trial in hospitalized COVID-19 patients. Patients will inhale Inhaleen or Placebo 3 times a day for 7 minutes for 5 days. The primary objective of the trial is to demonstrate that Inhaleen inhalation improves the clinical status of hospitalized COVID-19 patients on day 8 compared to placebo inhalation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
14
inhalation 3 times a day
inhalation 3 times a day
Gesundheitsverbund, Klinik Floridsdorf
Vienna, Austria
Clinical status of subjects as expressed on the WHO-8-Category ordinal scale:
1. Not hospitalized and no limitations of activities 2. Not hospitalized, with limitations of activities, home oxygen requirement, or both 3. Hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infections-control or other nonmedical reasons) 4. Hospitalized not requiring supplemental oxygen but requiring ongoing medical care related to COVID-19) or to other medical conditions) 5. Hospitalized requiring any supplemental oxygen 6. Hospitalized requiring non-invasive ventilation or use of high-flow oxygen devices 7. Hospitalized receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 8. Death
Time frame: day 8
Cycle threshold of SARS-CoV-2 PCR·
Time frame: until day 15
multiplex viral examination
NxTAG® Respiratory Pathogen Panel + SARS-CoV-2 (Luminex, Cat: X056C0470) detects and differentiates nucleic acids from SARS-CoV-2 and the following organism types and subtypes: Influenza A, Influenza A H1, Influenza A H3, Influenza B, Influenza A 2009 H1N1, Legionella pneumophila, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Coronavirus 229E, Coronavirus OC43, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.
Time frame: until day 15
supplemental oxygen requirement
Time frame: until day 15
modified 10 point BORG scale
a higher score means a worse condition
Time frame: day 1 to day 5
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