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Trial - NCT04964583


Column Value
Trial registration number NCT04964583
Full text link
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04964583

First author
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

Ivonne A Roy, MD

Contact
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

ivonne3316@gmail.com

Registration date
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

2021-07-16

Recruitment status
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - have given the signed informed consent form. - confirmed diagnosis of covid-19 infection by pcr with mild symptoms. - patients who attend the primary care respiratory care module in the participating units and who have symptoms suggestive of covid-19, who comply with the current operational definition. - with or without comorbidities such as hypertension, controlled diabetes mellitus, cardiovascular or respiratory diseases. - controlled diabetes will be considered to be that which is evidenced by results of glycosylated hemoglobin less than 7% in the last 3 tables, whether it is reported in your beneficiary file or by external laboratory results. - electrocardiogram (ecg) normal or with variations without clinical relevance, with qt interval <450 ms. - no contraindication to study drugs (history of hypersensitivity to study drugs, including macrolides, patients with renal failure (egfr <40 ml / min) or on renal replacement therapy, patients with a history of retinopathy or macular degeneration.

Exclusion criteria
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

- patients who are participating in studies with investigational drugs. - pregnancy or breastfeeding. - type 1 diabetes - % type ii diabetes mellitus with glycated hemoglobin greater than 7%. - patients requiring hospitalization or assisted mechanical ventilation - cardiac disorders with cardiac conduction delay (qt segment ≥ 450 ms

Number of arms
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

Coordinación de Investigación en Salud, Mexico

Inclusion age min
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

75

Countries
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

Mexico

Type of patients
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

105

primary outcome
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

Hospitalization

Notes
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

Phase 2/Phase 3

Arms
Last imported at : July 17, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1534, "treatment_name": "Azithromycin+hydroxychloroquine", "treatment_type": "Antibiotics+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]