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

NCT04793984 | Completed

• 1 other identifier: COVID-19/TCP_20_05
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 apply Carragelose® in an inhalative form. Hospitalized COVID-19 patients with respiratory symptoms will inhale Inhaleen for 5 days.

Conditions

Covid19

Keywords

Carragelose; iota-Carrageenan; lung; virus; respiratory virus; inhalation; common cold

Outcome Measures

Primary Outcomes (1)

• 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

  day 8

Secondary Outcomes (4)

• Cycle threshold of SARS-CoV-2 PCR·

  until day 15

• multiplex viral examination

  until day 15

• supplemental oxygen requirement

  until day 15

• modified 10 point BORG scale

  day 1 to day 5

Study Arms (2)

Inhaleen

EXPERIMENTAL

Iota-Carrageenan inhalation

Device: Carragelose

Placebo

PLACEBO COMPARATOR

NaCl inhalation

Device: NaCl

Interventions

Carragelose DEVICE

inhalation 3 times a day

Also known as: iota-Carageenan

Inhaleen

NaCl DEVICE

inhalation 3 times a day

Also known as: saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.)
• 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
• Pregnant/lactating women at the time of recruitment will be excluded from the study
• Participation in another antiviral clinical trial

Sponsors & Collaborators

• Marinomed Biotech AG: lead

Study Sites (1)

Gesundheitsverbund, Klinik Floridsdorf

Vienna, 1210, Austria

Location

MeSH Terms

Conditions

COVID-19; Virus Diseases; Respiratory Aspiration; Common Cold

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Picornaviridae Infections

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized placebo-controlled double blinded trial

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 11, 2021
• Study Start: March 8, 2021
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: August 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)