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

Primary Purpose

Covid19

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

High doses of intravenous vitamin C

Dextrose 500 mL

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Vitamin C- Covid-19

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean change in worst (highest)

Mean change in worst (highest) oxygenation level (oxygen saturation or oxygen flow in liters/min) in non-ventilated patients.

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.

Secondary Outcome Measures

Mortality

Duration of mechanical ventilation

Full Information

NCT ID

NCT05029037

First Posted

August 27, 2021

Last Updated

August 27, 2021

Sponsor

Hugo Galindo

1. Study Identification

Unique Protocol Identification Number

NCT05029037

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 15, 2021 (Anticipated)

Primary Completion Date

March 15, 2022 (Anticipated)

Study Completion Date

May 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Hugo Galindo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

Vitamin C- Covid-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

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

Arm Title

Group B

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

High doses of intravenous vitamin C

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dextrose 500 mL

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mean change in worst (highest)

Description

Mean change in worst (highest) oxygenation level (oxygen saturation or oxygen flow in liters/min) in non-ventilated patients.

Time Frame

Seven (7) days after randomization.

Title

Mean change in worst (lowest)

Description

Mean change in worst (lowest) PaO2 / FiO2 ratio (in mmHg) in ventilated patients. It should be within the first seven days after randomization.

Time Frame

Seven (7) days after randomization.

Secondary Outcome Measure Information:

Title

Mortality

Description

Mortality

Time Frame

up to day 28

Title

Duration of mechanical ventilation

Description

Duration of mechanical ventilation

Time Frame

Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hugo Galindo, MD

Phone

57 3006292776

hgalindo@grupogales.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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