COVID-19 trials registries data warehouse

 Return to trial list

Trial - NCT04507867


Column Value
Trial registration number NCT04507867
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04507867

First author
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Fernando Leal Martínez, Ph.D

Contact
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

ferman5@hotmail.com

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

2020-08-11

Recruitment status
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Completed

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

Sequential assignment

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

Treatment

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

inclusion criteria: - patients admitted to the issemym toluca medical center "arturo montiel rojas ", diagnosed with covid-19 confirmed by pcr. - patients in need of supplemental o2 with nasal prongs or reservoir-mask for sato2 <90% and respiratory distress. - with concomitant diseases such as cardiovascular disease, diabetes mellitus 2, hypertension, overweight or obesity bmi <35. - both sexes. - over 30 years old. - the patient tolerate oral feeding. - signing of the letter of informed consent.

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

- detachment from treatment. - admission to the icu for any reason. - patients who do not tolerate the oral route. - reactions to treatment that compromise the health of patients.

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

2

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

Anahuac University

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

30

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

75

Countries
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Mexico

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

Moderate/severe disease at enrollment

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

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

80

primary outcome
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Overall Mortality at Day 40;Overall Survival

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

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 916, "treatment_name": "Nutritional support system", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]