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

NCT05029037 | Unknown Phase 3 DMC

• 1 other identifier: DAVCI
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Covid19

Keywords

Vitamin C- Covid-19

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• Mortality

  up to day 28

• Duration of mechanical ventilation

  Days

Study Arms (2)

Group A

EXPERIMENTAL

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

Drug: High doses of intravenous vitamin C

Group B

PLACEBO COMPARATOR

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

Drug: Dextrose 500 mL

Interventions

High doses of intravenous vitamin C DRUG

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

Group A

Dextrose 500 mL 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.

Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hugo Galindo: lead

MeSH Terms

Conditions

COVID-19

Interventions

Glucose

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Central Study Contacts

Hugo Galindo, MD

CONTACT

57 3006292776; hgalindo@grupogales.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Hugo Galindo

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: August 31, 2021
• Study Start: September 15, 2021
• Primary Completion: March 15, 2022
• Study Completion: May 15, 2022
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share