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Trial - NCT04793984


Column Value
Trial registration number NCT04793984
Full text link
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : Aug. 30, 2022, 9:30 p.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : Aug. 30, 2022, 9:30 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-03-11

Recruitment status
Last imported at : Aug. 30, 2022, 9:30 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

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
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- 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

Number of arms
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Marinomed Biotech AG

Inclusion age min
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Austria

Type of patients
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Aug. 30, 2022, 9:30 p.m.
Source : ClinicalTrials.gov

14

primary outcome
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Clinical status of subjects as expressed on the WHO-8-Category ordinal scale:

Notes
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 255, "treatment_name": "Carragelose", "treatment_type": "Others non pharmacological treatment", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]