Status:
COMPLETED
Efficacy and Safety Evaluation of Inhaleen Inhalation in Hospitalized COVID-19 Patients
Lead Sponsor:
Marinomed Biotech AG
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04793984
Start Date
March 8 2021
End Date
July 30 2022
Last Update
August 29 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Gesundheitsverbund, Klinik Floridsdorf
Vienna, Austria, 1210