Efficacy and Safety Evaluation of Inhaleen Inhalation in Hospitalized COVID-19 Patients
NCT ID: NCT04793984
Last Updated: 2022-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2021-03-08
2022-07-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Inhaleen
Iota-Carrageenan inhalation
Carragelose
inhalation 3 times a day
Placebo
NaCl inhalation
NaCl
inhalation 3 times a day
Interventions
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Carragelose
inhalation 3 times a day
NaCl
inhalation 3 times a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Marinomed Biotech AG
INDUSTRY
Responsible Party
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Principal Investigators
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Arschang Valipour, MD
Role: PRINCIPAL_INVESTIGATOR
Karl Landsteiner Society; Clinic Floridsdorf
Georg-Christian Funk, MD
Role: PRINCIPAL_INVESTIGATOR
Karl Landsteiner Society, Clinic Ottakring
Wolfgang Hoeppler, MD
Role: PRINCIPAL_INVESTIGATOR
Gesundheitsverbund Klinik Favoriten
Locations
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Gesundheitsverbund, Klinik Floridsdorf
Vienna, , Austria
Countries
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Other Identifiers
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COVID-19/TCP_20_05
Identifier Type: -
Identifier Source: org_study_id
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