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

NCT ID: NCT05029037

Last Updated: 2021-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2022-05-15

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.

Conditions

Covid19

Keywords

Vitamin C- Covid-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A

80 patients randomized to group A will receive two doses (High) of vitamin C intravenously, twice a day for seven days.

Group Type: EXPERIMENTAL

High doses of intravenous vitamin C

Intervention Type: DRUG

Two (2) High doses of intravenous vitamin C for seven (7) days.

Group B

80 patients assigned to group B will receive two doses of Dextrose 500 mL, twice a day for seven days.

Group Type: PLACEBO_COMPARATOR

Dextrose 500 mL

Intervention Type: DRUG

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.

Interventions

High doses of intravenous vitamin C

Two (2) High doses of intravenous vitamin C for seven (7) days.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hugo Galindo

OTHER

Sponsor Role: lead

Responsible Party

Hugo Galindo

Dr. Hugo Galindo

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Hugo Galindo, MD

Role: CONTACT

Phone: 57 3006292776

Email: hgalindo@grupogales.com

Other Identifiers

DAVCI

Identifier Type: -

Identifier Source: org_study_id