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Trial - NCT04834115


Column Value
Trial registration number NCT04834115
Full text link
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04834115

First author
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Gabriela Avila, MD, MSc, PhD

Contact
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

mavila@med.una.py

Registration date
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-04-06

Recruitment status
Last imported at : April 6, 2023, 8 p.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : April 9, 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 : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - positive diagnostic rt-qpcr or antigen test for sars-cov-2 - symptomatic patients with up to 8 days from the onset of symptoms, and asymptomatic cases with up to 5 days of positive test for sars-cov-2. - patients who agree to participate in the study by signing the informed consent.

Exclusion criteria
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- patients with severity criteria defined in the coronavirus disease epidemiological and laboratory surveillance guide (version 3/11/2020) - pregnant or breastfeeding women - women of childbearing age and without commitment to use contraceptive methods during the study time. - inability to complete the study - current treatment with drugs known to interact with ivermectin - known intolerance to ivermectin, its derivate or any of its excipients. - patients with known child-pugh c liver disease - patients with prior ivermectin consumption in the 10 days prior to study entry.

Number of arms
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Universidad Nacional de Asunción

Inclusion age min
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Paraguay

Type of patients
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Mild/moderate disease at enrollment

Severity scale
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

400

primary outcome
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Proportion of patients with hospitalization criteria

Notes
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : April 9, 2021, 12:31 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"}]