Home and?Outpatients?Precocious?Eradication of?COVID-19

Home and?Outpatients?Precocious?Eradication of?COVID-19 - HOPE COVID-19

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000492-36-BE

Enrollment

104

Registered

2021-04-21

Start date

2021-05-31

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 MedDRA version: 23.0 Level: LLT Classification code 10084382 Term: Coronavirus disease 2019 System Organ Class: 100000004862

Interventions

Trade Name: Siroxyl sans sucre pour adultes 750 mg/15ml solution buvable Pharmaceutical Form: Oral solution INN or Proposed INN: carbocysteine CAS Number: 638-23-3 Current Sponsor code: HOPE-01-V Othe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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 Are the trial subjects under 18? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 94 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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, after full treatment completion.;Secondary Objective: 1)Clinical evolution based on the daily filling of the FLU-PRO self-questionnaire (daily comparison of the distribution and mean of FLU-PRO score in each investigation arm) 2)Rate of subjects in each investigation arm displaying a negative viral culture of a nasopharyngeal swab sample collected at Day 3 of experiment 3)Median time, in days, of viral shedding in the subjects in each investigation arm (time of viral shedding=nb of days in experiment of a saliva sample which RT-PCR Ct count is >34) 4)Evolution of the daily distribution and mean RT-PCR Ct count compared between the two investigation arms, performed on saliva samples collected daily in all the subjects, from Day 1 to Day 6 5)Rate of subjects in each investigation arm having reported any kind of adverse events and reactions including specific comparison according to : - the organic system they affect, be it encompassed by the table in Appendix 2 or not ; - their quality and severity class : AE, SAE, SUSAR ;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: after full treatment completion	—

Measure

Time frame

Main Objective: 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, after full treatment completion.;Secondary Objective: 1)Clinical evolution based on the daily filling of the FLU-PRO self-questionnaire (daily comparison of the distribution and mean of FLU-PRO score in each investigation arm) 2)Rate of subjects in each investigation arm displaying a negative viral culture of a nasopharyngeal swab sample collected at Day 3 of experiment 3)Median time, in days, of viral shedding in the subjects in each investigation arm (time of viral shedding=nb of days in experiment of a saliva sample which RT-PCR Ct count is >34) 4)Evolution of the daily distribution and mean RT-PCR Ct count compared between the two investigation arms, performed on saliva samples collected daily in all the subjects, from Day 1 to Day 6 5)Rate of subjects in each investigation arm having reported any kind of adverse events and reactions including specific comparison according to : - the organic system they affect, be it encompassed by the table in Appendix 2 or not ; - their quality and severity class : AE, SAE, SUSAR ;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: after full treatment completion

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 1)up to and including Day 10 of experiment 2)at Day 3 of experiment 3)from Day 1 to Day 6 4)from Day 1 to Day 6 5)from Day 1 to Day 10;Secondary end point(s): 1) Clinical evolution based on the daily filling of the FLU-PRO self-questionnaire, defined by daily comparison (up to and including Day 10 of experiment) of the distribution and mean of FLU-PRO score in each investigation arm, in points. 2) Rate, in percent, of subjects in each investigation arm displaying a negative viral culture (impossibility to cultivate SARS-CoV-2, see Section 7 for methodology) of a nasopharyngeal swab sample collected at Day 3 of experiment. 3) Median time, in days, of viral shedding in the subjects in each investigation arm ; time of viral shedding being defined as the number of days in experiment (starting Day 1) up to and not including the first Day of collection of a saliva sample which RT-PCR Ct count is above 34 (>34). 4) Evolution of the daily distribution and mean RT-PCR Ct count, in number of cycles, compared between the two investigation arms, performed on saliva samples collected daily in all the subjects, from Day 1 included to Day 6 included. 5) Rate, in percent, of subjects in each investigation arm having reported any kind of adverse events and reactions, either spontaneously or via prospective adverse event investigation (by daily phone calls of the Study Nurse), including specific comparison according to : - the organic system they affect, be it encompassed by the table in Appendix 2 or not ; - their quality and severity class : Adverse Event (AE), Severe Adverse Event (SAE), Suspected Unexpected Serious Adverse Reaction (SUSAR).	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 1)up to and including Day 10 of experiment 2)at Day 3 of experiment 3)from Day 1 to Day 6 4)from Day 1 to Day 6 5)from Day 1 to Day 10;Secondary end point(s): 1) Clinical evolution based on the daily filling of the FLU-PRO self-questionnaire, defined by daily comparison (up to and including Day 10 of experiment) of the distribution and mean of FLU-PRO score in each investigation arm, in points. 2) Rate, in percent, of subjects in each investigation arm displaying a negative viral culture (impossibility to cultivate SARS-CoV-2, see Section 7 for methodology) of a nasopharyngeal swab sample collected at Day 3 of experiment. 3) Median time, in days, of viral shedding in the subjects in each investigation arm ; time of viral shedding being defined as the number of days in experiment (starting Day 1) up to and not including the first Day of collection of a saliva sample which RT-PCR Ct count is above 34 (>34). 4) Evolution of the daily distribution and mean RT-PCR Ct count, in number of cycles, compared between the two investigation arms, performed on saliva samples collected daily in all the subjects, from Day 1 included to Day 6 included. 5) Rate, in percent, of subjects in each investigation arm having reported any kind of adverse events and reactions, either spontaneously or via prospective adverse event investigation (by daily phone calls of the Study Nurse), including specific comparison according to : - the organic system they affect, be it encompassed by the table in Appendix 2 or not ; - their quality and severity class : Adverse Event (AE), Severe Adverse Event (SAE), Suspected Unexpected Serious Adverse Reaction (SUSAR).

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026