Covid19NCT04793984
Efficacy and Safety Evaluation of Inhaleen Inhalation in Hospitalized COVID-19 Patients
A study testing Carragelose and NaCl in people with Covid19, run by Marinomed Biotech AG at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Carragelose and NaCl
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteAustria
- Study dates
- 8 Mar 2021to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Covid19
- Being tested
- Carragelose, NaCl
- Keywords
- Carragelose, iota-Carrageenan, lung, virus, respiratory virus, inhalation, common cold
- Medical subject headings
- COVID-19, Virus Diseases, Respiratory Aspiration, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarrageloseDevice
Also called iota-Carageenan
inhalation 3 times a day
NaClDevice
Also called saline
inhalation 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| Inhaleen | Experimental | Iota-Carrageenan inhalation Receives: Device: Carragelose |
| Placebo | Placebo comparator | NaCl inhalation Receives: Device: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 8
Secondary outcomes (4)
Cycle threshold of SARS-CoV-2 PCR·
Measured: 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.
Measured: until day 15
supplemental oxygen requirement
Measured: until day 15
modified 10 point BORG scale
a higher score means a worse condition
Measured: day 1 to day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start8 Mar 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized placebo-controlled double blinded trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marinomed Biotech AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arschang Valipour, MD, Principal investigator, Karl Landsteiner Society; Clinic FloridsdorfGeorg-Christian Funk, MD, Principal investigator, Karl Landsteiner Society, Clinic OttakringWolfgang Hoeppler, MD, Principal investigator, Gesundheitsverbund Klinik Favoriten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793984
- Sponsor's protocol ID
- COVID-19/TCP_20_05
- Status last verified
- Aug 2022
- First submitted
- 9 Mar 2021
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Inhaleen Inhalation in Hospitalized COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04793984
- Acronym / sponsor ID
- COVID-19/TCP_20_05
- Conditions
- Covid19
- Keywords
- Carragelose, iota-Carrageenan, lung, virus, respiratory virus, inhalation, common cold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Marinomed Biotech AGIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized placebo-controlled double blinded trial
| Arm | Type | Receives |
|---|---|---|
| Inhaleen | Experimental | Device: CarrageloseIota-Carrageenan inhalation |
| Placebo | Placebo comparator | Device: NaClNaCl inhalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarrageloseAlso: iota-Carageenaninhalation 3 times a day | Device | Inhaleen |
| NaClAlso: salineinhalation 3 times a day | Device | Placebo |
Primary outcome
Clinical status of subjects as expressed on the WHO-8-Category ordinal scale:
Time frame: day 8
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
4 secondary outcomes
Cycle threshold of SARS-CoV-2 PCR·
Time frame: until day 15
multiplex viral examination
Time frame: until day 15
supplemental oxygen requirement
Time frame: until day 15
modified 10 point BORG scale
Time frame: day 1 to day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carragelose and NaCl in people with Covid19, run by Marinomed Biotech AG at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical status of subjects as expressed on the WHO-8-Category ordinal scale: (time frame: day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.