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Trial - NCT04340349


Column Value
Trial registration number NCT04340349
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04340349

First author
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Julio Granados Montiel

Contact
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-04-09

Recruitment status
Last imported at : June 5, 2023, 8 a.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

inclusion criteria - health personnel working at inr lgii or incmnsz who wish to participate in the study and sign the informed consent. - over 18 and under 60 years of age, both genders. - contacting with suspected or confirmed sars-cov-2 infection. - normal electrocardiogram. exclusion criteria - positive quantitative reverse transcriptase-polymerase chain reaction (qrt-pcr) test for sars-cov-2 at the time of inclusion. - panel of igg or igm antibodies positive for sars-cov-2 at the time of inclusion. - development of respiratory symptoms suspicious of sars-cov-2 infection during the first 7 days after treatment is initiated, confirmed by qrt-pcr and igg or igm antibodies postiver for sars-cov-2. - history of allergies to any hydroxychloroquine or bromhexine related compound or medication. - use of immunosuppressors for any reason. - history of bone marrow transplant. - known glucose-6-phosphate dehydrogenase deficiency. - chronic kidney disease or glomerular filtration <20ml/min. - use of other drugs with reported pharmacological interactions (i.e., digitalis, flecainide, amiodarone, procainamide, or propafenone). - history of long qt syndrome. - electrocardiogram with qtc>500 msec. - pregnant or breastfeeding personnel. - epilepsy. - known liver disease. - personnel who have received the covid-19 vaccine elimination criteria - personnel who decide to leave the study for any reason not related to adverse events. - personnel with incomplete information on the primary outcome (qrt-pcr for sars-cov-2). - personnel who are relocated to work in another institution. - personnel who do not wish to participate in the study

Exclusion criteria
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Number of arms
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Instituto Nacional de Rehabilitacion

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mexico

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Health workers

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

214

primary outcome
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Quantification of the expression of mRNA SARS-CoV-2 and presence or absence of antibodies anti-SARS-CoV-2

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

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

Phase 1

Arms
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1545, "treatment_name": "Bromhexine+hydroxychloroquine", "treatment_type": "Respiratory agents+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]