CompletedNCT04793984Updated Aug 29, 2022

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

An interventional study of Carragelose and NaCl in Covid19, sponsored by Marinomed Biotech AG. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-29.

Sponsored by Marinomed Biotech AG · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 14
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Covid19

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Keywords

Carragelose
iota-Carrageenan
lung
virus
respiratory virus
inhalation
common cold

In context

COVID-19

7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 14 is below the median of 100 across 4,175 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Marinomed Biotech AG is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 14 participants (actual)

Study arms

Experimental
Inhaleen
Iota-Carrageenan inhalation
Device: Carragelose
Placebo comparator
Placebo
NaCl inhalation
Device: NaCl

Interventions

DeviceCarragelose
inhalation 3 times a day
Also known as: iota-Carageenan
DeviceNaCl
inhalation 3 times a day
Also known as: saline

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Gesundheitsverbund, Klinik Floridsdorf
Vienna, 1210, Austria

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2021 to primary completion in Jul 2022, 16 months.

Of 130 industry-sponsored interventional studies with no phase under COVID-19, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 11. This study's 16 months is above that.

Counting every sponsor, half of 1,425 studies reached it within 9 months; a quarter within 3 and three quarters within 19.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 9, 2021
First posted: Mar 11, 2021
StartActual: Mar 8, 2021
Primary completionActual: Jul 30, 2022
CompletionActual: Jul 30, 2022
Last update: Aug 29, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04793984
Lead sponsor: Marinomed Biotech AG
Responsible party: Sponsor
First posted: Mar 11, 2021
Start date: Mar 8, 2021
Primary completion: Jul 30, 2022
Completion: Jul 30, 2022
Last update: Aug 29, 2022

Study contacts

Arschang Valipour, MD

principal investigator · Karl Landsteiner Society; Clinic Floridsdorf

Georg-Christian Funk, MD

principal investigator · Karl Landsteiner Society, Clinic Ottakring

Wolfgang Hoeppler, MD

principal investigator · Gesundheitsverbund Klinik Favoriten

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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