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Trial - NCT05040724


Column Value
Trial registration number NCT05040724
Full text link
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05040724

First author
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

2021-09-10

Recruitment status
Last imported at : June 8, 2023, noon
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Sept. 14, 2021, 4:30 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 : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - patient ≥ 18 years old, - symptomatic covid-19 for less than 96 hours (see list of symptoms in appendix), - tested positive for sars-cov-2 by rt-pcr on a nasopharyngeal sample within 48 hours of inclusion, - following an effective method of contraception for women of childbearing age, - affiliated to a social security scheme, - informed and written consent from patient.

Exclusion criteria
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

- patient requiring normal hospitalization or intensive care - oxygen-requiring patient, - with a history of parasitosis, in particular filariasis, - with a history of hypereosinophilia, - notion of recent travel (less than 3 months) in poor hygienic conditions - taking ivermectin in the last 12 months, - contraindications to ivermectin or one of the constituents of the drug (known history of allergies), - pregnant or breastfeeding women, - participation in another interventional study relating to covid-19 concerning a drug during this research, - patient under ame or without social security coverage.

Number of arms
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Raincy Montfermeil Hospital Group

Inclusion age min
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

France

Type of patients
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

200

primary outcome
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

negativation of the RT-PCR test on nasopharyngeal samples of SARS-CoV-2

Notes
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]