High-dose Intravenous Vitamin C (HDIVC) as Adjuvant Therapy in Critical Patients With Positive COVID-19. A Pilot Randomized Controlled Dose-comparison Trial.

Covid19 Clinical Trial

— HDIVC  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05029037
• Other study ID #: DAVCI
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 15, 2021
• Est. completion date: May 15, 2022

Study information

• Verified date: August 2021
• Source: Fundacion Epheta
• Contact: Hugo Galindo, MD
• Phone: 57 3006292776
• Email: hgalindo[@]grupogales.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: May 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• High doses of intravenous vitamin C
Two (2) High doses of intravenous vitamin C for seven (7) days.
• Dextrose 500 mL
Application of a vial of LEV in 100 mL of water for injection, which is diluted in 400mL of 5% Dextrose for a final volume of 500mL of intravenous fluids, to be applied to the chosen patient, in a drip of 0.5 grams of the placebo solution per minute, for a total of 60 minutes. Twice a day for seven days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hugo Galindo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in worst (highest)	Mean change in worst (highest) oxygenation level (oxygen saturation or oxygen flow in liters/min) in non-ventilated patients.	Seven (7) days after randomization.
Primary	Mean change in worst (lowest)	Mean change in worst (lowest) PaO2 / FiO2 ratio (in mmHg) in ventilated patients. It should be within the first seven days after randomization.	Seven (7) days after randomization.
Secondary	Mortality	Mortality	up to day 28
Secondary	Duration of mechanical ventilation	Duration of mechanical ventilation	Days