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

Marinomed Biotech

Status

Completed

Conditions

Covid19

Treatments

Device: NaCl

Device: Carragelose

Study type

Interventional

Funder types

Industry

Identifiers

NCT04793984

COVID-19/TCP_20_05

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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