| Trial registration number
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EUCTR2021-000492-36-BE |
Full text link
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000492-36/BE
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First author
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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Centre académique de médecine générale
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Contact
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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Not reported
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Registration date
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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2021-04-21
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Recruitment status
Last imported at : Sept. 18, 2023, 2:45 p.m.
Source : EU Clinical Trials Register
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Completed
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Study design
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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RCT
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Allocation
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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Randomized
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Design
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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Parallel
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Masking
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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Blind label
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Center
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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single-center
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Study aim
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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Treatment
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Inclusion criteria
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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- Provided informed consent following an exhaustive and fully-understood information
- Aged ≥16 years and ≤65 years
- Does not present any criteria of redirection towards the Emergency Room or towards a direct hospitalization
- Time from symptom onset (TFSO) ≤48 hours AND tested positive at the Rapid Antigenic Test
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Exclusion criteria
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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- Pregnancy, breastfeeding, or any woman of child-bearing potential that does not benefit from any proper contraception and whose Last Menstrual Period occurred 20 days ago or more (≥ 20 days).
- Immunosuppression, whatever the type, including drug-induced cases.
- COVID-19 requiring hospitalization or redirection towards the Emergency Room.
- Anti-COVID-19 vaccination, whatever the vaccine, as soon as first dose has been administered.
- Former COVID-19 infection diagnosed upon positive SARS-CoV-2 RT-PCR test results.
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Number of arms
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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2
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Funding
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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UCLouvain
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Inclusion age min
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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16
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Inclusion age max
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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65
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Countries
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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Belgium
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Type of patients
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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Mild disease at enrollment
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Severity scale
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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1: Mild disease at enrollment
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Total sample size
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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104
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primary outcome
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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Rate, in percent, of subjects in each investigation arm displaying a SARS-CoV-2 RT-PCR Ct count above 34 (>34 cycles) performed on a saliva sample collected at Day 6 of experiment
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Notes
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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Declared number of arm (3.0)
differs from found arms (2.0)
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Phase
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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Phase 2
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Arms
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register
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[{"arm_notes": "", "treatment_id": 253, "treatment_name": "Carbocysteine", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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