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

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Carragelose
NaCl
Sponsored by
Marinomed Biotech AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Carragelose, iota-Carrageenan, lung, virus, respiratory virus, inhalation, common cold

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gesundheitsverbund, Klinik Floridsdorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inhaleen

Placebo

Arm Description

Iota-Carrageenan inhalation

NaCl inhalation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cycle threshold of SARS-CoV-2 PCR·
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.
supplemental oxygen requirement
modified 10 point BORG scale
a higher score means a worse condition

Full Information

First Posted
March 9, 2021
Last Updated
August 24, 2022
Sponsor
Marinomed Biotech AG
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1. Study Identification

Unique Protocol Identification Number
NCT04793984
Brief Title
Efficacy and Safety Evaluation of Inhaleen Inhalation in Hospitalized COVID-19 Patients
Official Title
Efficacy and Safety Evaluation of Inhaleen Inhalation in Hospitalized COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marinomed Biotech AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Carragelose, iota-Carrageenan, lung, virus, respiratory virus, inhalation, common cold

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized placebo-controlled double blinded trial
Masking
ParticipantInvestigator
Masking Description
double blinded
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhaleen
Arm Type
Experimental
Arm Description
Iota-Carrageenan inhalation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
NaCl inhalation
Intervention Type
Device
Intervention Name(s)
Carragelose
Other Intervention Name(s)
iota-Carageenan
Intervention Description
inhalation 3 times a day
Intervention Type
Device
Intervention Name(s)
NaCl
Other Intervention Name(s)
saline
Intervention Description
inhalation 3 times a day
Primary Outcome Measure Information:
Title
Clinical status of subjects as expressed on the WHO-8-Category ordinal scale:
Description
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
Time Frame
day 8
Secondary Outcome Measure Information:
Title
Cycle threshold of SARS-CoV-2 PCR·
Time Frame
until day 15
Title
multiplex viral examination
Description
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
Title
supplemental oxygen requirement
Time Frame
until day 15
Title
modified 10 point BORG scale
Description
a higher score means a worse condition
Time Frame
day 1 to day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arschang Valipour, MD
Organizational Affiliation
Karl Landsteiner Society; Clinic Floridsdorf
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Georg-Christian Funk, MD
Organizational Affiliation
Karl Landsteiner Society, Clinic Ottakring
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wolfgang Hoeppler, MD
Organizational Affiliation
Gesundheitsverbund Klinik Favoriten
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gesundheitsverbund, Klinik Floridsdorf
City
Vienna
ZIP/Postal Code
1210
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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