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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Device: Carragelose; Device: NaCl

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1210
    • Gesundheitsverbund, Klinik Floridsdorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inhaleen; Iota-Carrageenan inhalation	Device: Carragelose; inhalation 3 times a day; Other Names: iota-Carageenan
Placebo Comparator: Placebo; NaCl inhalation	Device: NaCl; inhalation 3 times a day; Other Names: saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cycle threshold of SARS-CoV-2 PCR·		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.	until day 15
supplemental oxygen requirement		until day 15
modified 10 point BORG scale	a higher score means a worse condition	day 1 to day 5

Collaborators and Investigators

• Sponsor: Marinomed Biotech AG
• Investigators: Principal Investigator: Arschang Valipour, MD, Karl Landsteiner Society; Clinic Floridsdorf; Principal Investigator: Georg-Christian Funk, MD, Karl Landsteiner Society, Clinic Ottakring; Principal Investigator: Wolfgang Hoeppler, MD, Gesundheitsverbund Klinik Favoriten

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: lung; inhalation; virus; respiratory virus; Carragelose; common cold; iota-Carrageenan
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Aspiration
• Other Study ID Numbers: COVID-19/TCP_20_05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No