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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaleen | Experimental | Iota-Carrageenan inhalation |
|
| Placebo | Placebo Comparator | NaCl inhalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carragelose | Device | inhalation 3 times a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical status of subjects as expressed on the WHO-8-Category ordinal scale: |
| day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Cycle threshold of SARS-CoV-2 PCR· | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arschang Valipour, MD | Karl Landsteiner Society; Clinic Floridsdorf | Principal Investigator |
| Georg-Christian Funk, MD | Karl Landsteiner Society, Clinic Ottakring | Principal Investigator |
| Wolfgang Hoeppler, MD | Gesundheitsverbund Klinik Favoriten | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gesundheitsverbund, Klinik Floridsdorf | Vienna | 1210 | Austria |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D014777 | Virus Diseases |
| D053120 | Respiratory Aspiration |
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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randomized placebo-controlled double blinded trial
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double blinded
| NaCl | Device | inhalation 3 times a day |
|
|
| until day 15 |
| supplemental oxygen requirement | until day 15 |
| modified 10 point BORG scale | a higher score means a worse condition | day 1 to day 5 |
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010850 | Picornaviridae Infections |