Efficacy and Safety Evaluation of Inhaleen Inhalation in Hospitalized COVID-19 Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Safety Evaluation of Inhaleen Inhalation in Hospitalized COVID-19 Patients

Conditions
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Covid19

Intervention / Treatment
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* Device: Carragelose
* Device: NaCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent obtained before any trial related procedures are performed Age ≥ 18 years Hospitalized patients with PCR confirmed SARS-CoV-2 infection and symptom onset ≤ 10 days before randomization Patients with respiratory COVID-19 symptoms Randomization ≤ 48h from admission Peripheral capillary oxygen saturation (SpO2) ≥ 90% on room air or supplemental oxygen at screening Patient agrees to refrain from taking other carragelose products (e.g. throat spray, lozenges) Exclusion Criteria: No informed consent Persistent hypoxemia with SpO2 < 90% despite supplemental oxygen of > 6LO2/min at screening. Patients with predominantly extrapulmonary COVID-19 symptoms (e.g. gastrointestinal, neurological, etc.) Subjects who demonstrate respiratory and/or cardiac instability that is considered by the investigator as a reason for exclusion. Additionally, any other clinically significant disease that could interfere with participation in the study, with the intervention being studied, or with the evaluation of symptoms. Specific exclusions are asthma, immune deficiency, autoimmune disease, clinically significant cardiovascular, endocrinological, neurological, respiratory, gastrointestinal disease or any disease that is considered by the investigator as a reason for exclusion. Known hypersensitivity or allergy to any component of the test product The subject is related to any study personnel or has any other close ties or conflicts of interest with the study sponsor. The subject has received any investigational drug or participated in a clinical trial within 4 weeks of entry to this study Current medication other than oral contraception,that is considered by the investigator as a reason for exclusion. Pregnant/lactating women at the time of recruitment will be excluded from the study Participation in another antiviral clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized placebo-controlled double blinded trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaleen<br>Iota-Carrageenan inhalation | Device: Carragelose<br>* inhalation 3 times a day<br>* Other names: iota-Carageenan;|
| Placebo Comparator: Placebo<br>NaCl inhalation | Device: NaCl<br>* inhalation 3 times a day<br>* Other names: saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical status of subjects as expressed on the WHO-8-Category ordinal scale: | Not hospitalized and no limitations of activities Not hospitalized, with limitations of activities, home oxygen requirement, or both Hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infections-control or other nonmedical reasons) Hospitalized not requiring supplemental oxygen but requiring ongoing medical care related to COVID-19) or to other medical conditions) Hospitalized requiring any supplemental oxygen Hospitalized requiring non-invasive ventilation or use of high-flow oxygen devices Hospitalized receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Death | day 8 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carragelose, iota-Carrageenan, lung, virus, respiratory virus, inhalation, common cold