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Trial - NCT04673214


Column Value
Trial registration number NCT04673214
Full text link
Last imported at : Dec. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04673214

First author
Last imported at : Aug. 17, 2021, 6 p.m.
Source : ClinicalTrials.gov

GILBERTO CR ARTEAGA, specialist

Contact
Last imported at : Aug. 17, 2021, 6 p.m.
Source : ClinicalTrials.gov

gilberto.cruz@imss.gob.mx

Registration date
Last imported at : Dec. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2020-12-17

Recruitment status
Last imported at : Aug. 17, 2021, 6 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Dec. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Dec. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Dec. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Dec. 19, 2020, 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 : Dec. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Dec. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - patients eligible for family medicine unit no.20 and family medicine unit no.13 belonging to the north df of the imss. - male and female patients - patients over 18 years of age. - patients with compliance with the operational definition covid-19 and confirmatory test of p.c.r. positive within the first days of the illness (that are evaluated in first level of medical attention). - patients with comorbidities such as type 2 diabetes mellitus, systemic arterial hypertension, overweight or obesity. - that they agree to sign an informed consent - related to video call: - that the family medicine unit no.20 and the family medicine unit no.13 belonging to the north df of the imss have the installation of electronic equipment for internet use

Exclusion criteria
Last imported at : Dec. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

- severe covid-19 patients (ameriten sent immediately to second level of care, hospital) patients with any personal pathological history of hematological diseases. • patients allergic to macrolides (azithromycin) and ivermectin.

Number of arms
Last imported at : Dec. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Dec. 4, 2022, 8 p.m.
Source : ClinicalTrials.gov

Gilberto Cruz Arteaga

Inclusion age min
Last imported at : Dec. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Dec. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Dec. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Mexico

Type of patients
Last imported at : Dec. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Mild/moderate disease at enrollment

Severity scale
Last imported at : Dec. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : Aug. 17, 2021, 6 p.m.
Source : ClinicalTrials.gov

114

primary outcome
Last imported at : Dec. 4, 2022, 8 p.m.
Source : ClinicalTrials.gov

Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.;Crosstabulated Outcome in Modification of the Evolution Clinical vs Fails Therapeutic by Type of Treatment in Patients With COVID-19 UMF 13 and UMF 20 of the IMSS

Notes
Last imported at : Dec. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Dec. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2271, "treatment_name": "Azithromycin+ivermectin+paracetamol+rivaroxaban", "treatment_type": "Antibiotics+antiparasitics+central nervous system agents+coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2272, "treatment_name": "Azithromycin+paracetamol+rivaroxaban", "treatment_type": "Antibiotics+central nervous system agents+coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]