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Trial - NCT04517422


Column Value
Trial registration number NCT04517422
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04517422

First author
Last imported at : Feb. 2, 2021, 5:16 p.m.
Source : ClinicalTrials.gov

Pedro Gutierrez-Castrellon, MD, PhD

Contact
Last imported at : Feb. 2, 2021, 5:16 p.m.
Source : ClinicalTrials.gov

pedro.gutierrez@councilforprobiotics.org;pedro.gutierrez@ideas-salud.mx

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

2020-08-18

Recruitment status
Last imported at : Feb. 19, 2021, 12:31 a.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

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

Treatment

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

inclusion criteria: - women or men, >18y to 60 years - rtq-pcr to covid positive - presence of cough, fever, dyspnoea, or headache, onset <= 7 days - mild severity of covid-19 - peripheral oxygen saturation (spo2) >90% - able to read, understand and sign the informed consent - to have at least one family member to collaborate with the follow-up in the clinical findings at beginning and throughout of the study.

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

- severe obesity (bmi>40) - uncontrolled type ii diabetes (hba1c >8.0) - uncontrolled systolic hypertension (>160mmdehg) - acute pancreatitis - chronic diarrhea or constipation - inflammatory bowel disease - blood clotting disease - immunosuppression derived from cancer, post-transplantation, auto-immune disease or hiv - severe and active seasonal allergies - pregnancy or lactation - glucose 6p-dehydrogenase deficiency - regular use of probiotic or antibiotic within 2 weeks before entering the trial - severe or uncontrolled chronic respiratory diseases (asthma, copd or cystic fibrosis)

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

AB Biotics, SA

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

18

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

60

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

Mild disease at enrollment

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

1: Mild disease at enrollment

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

300

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

Stay at ICU;Mortality ratio;Severity progression of COVID-19

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. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1022, "treatment_name": "Probiotics", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]