Covid19Phase 3HDIVCNCT05029037
High-dose Intravenous Vitamin C (HDIVC) as Adjuvant Therapy in Critical Patients With Positive COVID-19. A Pilot Randomized Controlled Dose-comparison Trial.
A Phase 3 study testing High doses of intravenous vitamin C and Dextrose 500 mL in people with Covid19, run by Hugo Galindo.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19
- What is being tested?
- High doses of intravenous vitamin C and Dextrose 500 mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2021to 15 May 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- High doses of intravenous vitamin C, Dextrose 500 mL
- Keywords
- Vitamin C- Covid-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High doses of intravenous vitamin CDrug
Two (2) High doses of intravenous vitamin C for seven (7) days.
Dextrose 500 mLDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 80 patients randomized to group A will receive two doses (High) of vitamin C intravenously, twice a day for seven days. Receives: 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. Receives: Drug: Dextrose 500 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in worst (highest)
Mean change in worst (highest) oxygenation level (oxygen saturation or oxygen flow in liters/min) in non-ventilated patients.
Measured: 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.
Measured: Seven (7) days after randomization.
Secondary outcomes (2)
Mortality
Mortality
Measured: up to day 28
Duration of mechanical ventilation
Duration of mechanical ventilation
Measured: Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start15 Sep 2021 (estimated)
- Primary completion15 Mar 2022 (estimated)
- Study completion15 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hugo Galindo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hugo Galindo, Fundacion Epheta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029037
- Sponsor's protocol ID
- DAVCI
- Acronym
- HDIVC
- Status last verified
- Aug 2021
- First submitted
- 27 Aug 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05029037
- Acronym / sponsor ID
- HDIVC / DAVCI
- Conditions
- Covid19
- Keywords
- Vitamin C- Covid-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hugo GalindoUniversity, hospital or other
- Study start
- 15 Sep 2021 (estimated)
- Primary completion
- 15 Mar 2022 (estimated)
- Study completion
- 15 May 2022 (estimated)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: High doses of intravenous vitamin C80 patients randomized to group A will receive two doses (High) of vitamin C intravenously, twice a day for seven days. |
| Group B | Placebo comparator | Drug: Dextrose 500 mL80 patients assigned to group B will receive two doses of Dextrose 500 mL, twice a day for seven days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High doses of intravenous vitamin CTwo (2) High doses of intravenous vitamin C for seven (7) days. | Drug | Group A |
| Dextrose 500 mLApplication 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. | Drug | Group B |
Primary outcome
Mean change in worst (highest)
Time frame: Seven (7) days after randomization.
Mean change in worst (highest) oxygenation level (oxygen saturation or oxygen flow in liters/min) in non-ventilated patients.
Mean change in worst (lowest)
Time frame: Seven (7) days after randomization.
Mean change in worst (lowest) PaO2 / FiO2 ratio (in mmHg) in ventilated patients. It should be within the first seven days after randomization.
2 secondary outcomes
Mortality
Time frame: up to day 28
Duration of mechanical ventilation
Time frame: Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing High doses of intravenous vitamin C and Dextrose 500 mL in people with Covid19, run by Hugo Galindo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hugo Galindo, MD (57 3006292776, hgalindo@grupogales.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in worst (highest) (time frame: Seven (7) days after randomization.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.