Clinical trial NCT05029037: High-dose Intravenous Vitamin C (HDIVC) as Adjuvant Therapy in Critical Patients With Positive COVID-19. A Pilot Randomized Controlled Dose-comparison Trial.
Official title: High-dose Intravenous Vitamin C (HDIVC) as Adjuvant Therapy in Critical Patients With Positive COVID-19. A Pilot Randomized Controlled Dose-comparison Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Covid19
Keywords: Vitamin C- Covid-19
Lead sponsor: Fundacion Epheta
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the impact of this HDIVC therapy in the first treatment of symptomatic Covid-19 patients in a time period of one week.

Detailed description: We consider that treatment with high doses of injectable vitamin C HDIVC could have a positive impact as an adjunct on the immunity of patients with Covid while reducing the possibility of worsening their clinical picture. Similarly, we wish to evaluate the efficacy of this treatment, for one week, in patients hospitalized in the ICU, in order to reduce the inflammatory burden and reduce hospital stay.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Mean change in worst (highest)
timeFrame: Seven (7) days after randomization.
measure: Mean change in worst (lowest)
timeFrame: Seven (7) days after randomization.
Secondary outcomes:
measure: Mortality
timeFrame: up to day 28
measure: Duration of mechanical ventilation
timeFrame: Days
Other outcomes:
Locations:
Study officials:
References: