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Trial - NCT05029037


Column Value
Trial registration number NCT05029037
Full text link
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

Hugo Galindo, MD

Contact
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

hgalindo@grupogales.com

Registration date
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

2021-08-31

Recruitment status
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

unclear

Study aim
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - adult patients with consent, adult men or women, age ≥ 18 years. - laboratory confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assays; and/or clinical findings suggesting infection. - hospitalized with a sars-cov-2 infection of any duration. - ability to provide an informed consent signed by the study patient or a legally acceptable representative. - willingness and ability to comply with the procedures/evaluations related to the study. - have an oxygen saturation (sao2) of 94% or less while breathing room air; or a ratio between the partial pressure of oxygen (pao2) and the fraction of inspired oxygen (fio2) (pao2: fio2) equal to or less than 300 mg. hg. (who defines pafi less than or equal to 250; being mild: 200-300; moderate: 100-200; severe: 100 or less. - normal kidney function: (creatinine 0.7 mg / dl for men or 20 to 200ng / ml and 0.6 to 1.1 mg / dl for women or 15-150 ng / ml); urinary output greater than or equal to 1 cc / kg / hour; glomerular filtration rate greater than 30 cc / min). - without chronic kidney disease (ckd) defined by stage ii or higher according to the kidney disease improving global outcomes (kdigo) classification.

Exclusion criteria
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

- age <18 or pregnant or lactating woman. - allergy to vitamin c. - severe liver failure. - egfr ≤ 30 ml / min / 1.73 m2 (defined by the ckd-epi scr formula). - history of any organ transplants requiring treatment active immunosuppressant that may interfere with kidney function. - if you required cardiopulmonary resuscitation (cpr) within 14 days, and/or dnr orders (do not resuscitate) dni (do not intubate). - if death is considered imminent or unavoidable during this admission, and the treating physician, patient, or surrogate decision-maker is not engaged in active treatment. - be on dialysis (either acute or chronic) or need dialysis imminent at the time of enrollment. - patients with known hiv infection. - patients with a known or suspected history of nephropathy due to oxalate or hyperoxaluria, scurvy, chronic iron overload, deficiency by g-6pd. - patients with known hemochromatosis.

Number of arms
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

Hugo Galindo

Inclusion age min
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

80

Countries
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

Severe/critical disease at enrollment

Severity scale
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

7: Severe/critical disease at enrollment

Total sample size
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

160

primary outcome
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

Mean change in worst (highest);Mean change in worst (lowest)

Notes
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1369, "treatment_name": "Vitamin c", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]