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Trial - NCT04886362


Column Value
Trial registration number NCT04886362
Full text link
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04886362

First author
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Juan Carlos Chacón Jimenez, MD

Contact
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

ceivercol@suramericana.com.co

Registration date
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2021-05-14

Recruitment status
Last imported at : May 5, 2023, 8 p.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

unclear

Study aim
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - age equal to or greater than 18 years. - patients with positive antigen test or rt-pcr for sars-cov-2. - patients with less than 7 days from symptoms onset. - patients with indication for outpatient management. - patients with mild disease according to the official guide "pneumonia diagnosis and treatment scheme for novel coronavirus infection (trial version 8)": subjects with mild symptoms, with or without radiological signs of pneumonia, with oxygen saturation>90% . - able to provided consent to participate.

Exclusion criteria
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

- patients who at the time of admission require hospitalization and / or supplemental oxygen. - known history of allergy to ivermectin. - known medical history of liver disease. - belong to another clinical trial evaluating the efficacy of an investigational drug against covid-19. - the following comorbidities: - immunosuppression or hiv. - acute or chronic kidney failure. - current neoplasia. - currently use of warfarin, erdafitinib, or quinidine. - have received vaccination for sars-cov-2. - ivermectin consumption prior to inclusion in the research protocol. - the patient does not accept the conditions of home care and monitoring. - the patient desists from participating in the study. - women in pregnancy or breastfeeding.

Number of arms
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Ayudas Diagnosticas Sura S.A.S

Inclusion age min
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

966

primary outcome
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Composite Outcome

Notes
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Phase 2/Phase 3

Arms
Last imported at : May 16, 2021, 12:32 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"}]