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High-Dose Vitamin C Treatment in Critically Ill COVID-19 Patients

High-Dose Vitamin C Treatment in Critically Ill COVID-19 Patients, A Retrospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04710329
Enrollment
78
Registered
2021-01-14
Start date
2021-01-16
Completion date
2021-02-10
Last updated
2021-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Respiratory Distress Syndrome, Adult

Keywords

coronavirus disease 2019, Ascorbic Acid, intensive care

Brief summary

Acute respiratory failure due to COVİD-19 pneumonia has poor prognosis and high mortality . Both the lack of an effective antiviral treatment and the low level evidence of the recommendations presented in the guidelines on other treatment methods have highlighted supportive treatments. Studies suggest that high-dose vitamin C treatment reduces mortality in patients with sepsis and ARDS, and may also be beneficial in COVİD-19 disease. In the study; the investigator aimed to determine the effect of Vitamin C on short-term mortality and length of intensive care stay in COVID-19 patients.

Detailed description

SARS-CoV-2 causes tissue damage in the endothelium and epithelium, increased vascular permeability and increased plasma levels of IL-6, IL-2, IL-7, IL-10 causing interstitial fibrosis in the lung is considered. Considering these factors in pathogenesis, a picture with high mortality from acute respiratory failure to severe ARDS emerges in critically ill COVID-19 patients. However, despite numerous studies, an effective antiviral treatment has not yet been found in COVID-19 disease. The low level of evidence for the recommendations presented in the guidelines on both treatment and mechanical ventilation has brought supportive treatments to the agenda. Recently, many articles have been published on the potential effects of anti-inflammatory and antioxidant treatments such as high-dose vitamin C, vitamin D, zinc and ozone therapy. In particular, high-dose intravenous vitamin C treatment is inexpensive, easily accessible, and it reduces mortality in patients with sepsis and ARDS in studies, suggesting that it may be beneficial in COVID-19 disease. this is a retrospective cohort study. The main goal of the study; to compare patients who did not receive high-dose vitamin C treatment in the first period of the epidemic and those who received treatment in the next period. the investigator aimed to determine the effect of Vitamin C on short-term mortality and length of stay in intensive care in critically ill COVID-19 patients. All patients' data on age, gender, body mass index, comorbidities (diabetes mellitus, hypertension, coronary artery disease, chronic obstructive pulmonary disease, other), PaO2 / FiO2 ratios, SOFA scores, ferritin, C-Reactive Protein, procalcitonin, lactate, neutrophil and lymphocyte values will be collected by scanning the hospital information system.

Interventions

DRUGAscorbic acid

The daily administration of 6 grams of vitamin C intravenously in 4 equal doses every 6 hours occurred and the treatment lasted 96 hours. Vials containing 1.5 gr vitamin C were placed in 100 cc 5% dextrose and infused intravenously in 30-60 minutes. Prepared serum bottles and sets are wrapped with aluminum foil in order to protect them from sunlight.

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Hospitalized with diagnosis of COVID-19, diagnosis confirmed by PCR test * pneumonia due to COVID-19 was diagnosed with clinical and radiological findings * Patients who developed acute respiratory failure (PaO2 / FiO2 300 despite the use of 6 l / min reservoir mask) caused by COVID-19 pneumonia * Older than 18 year

Exclusion criteria

* Renal failure * Hepatic failure * End-stage malignity * Primary lung disease (lung cancer, cardio-pulmonary edema) * Patients who treated with tocilizumab * Presence of diabetic ketoacidosis, use of insulin infusion, or frequent need for point-of-care glucose monitoring (\>6 times/24 hour period) as determined by treating physician * Active kidney stone * patients with hospitalization in ICU less than 96 hours

Design outcomes

Primary

MeasureTime frameDescription
short term mortalitydays 1-28Incidence of mortality at 28 days by all causes
Length of Intensive Care Unit Stayup to 28 daysLength of Intensive Care Unit Stay

Secondary

MeasureTime frameDescription
PaO2/FiO2 ratio1-4 dayChange in PaO2/FiO2 ratio from admission to 4th day
C-reactive protein1-4 daysChange in C-reactive protein from admission to 4th day
procalcitonin1-4 daysChange in procalcitonin from admission to 4th day
vasopressor requirement1-28 daysall types of vasopressor requirement in intensive care stay
ferritin1-4 daysChange in ferritin from admission to 4th day
SOFA1-4 daysChange in Sequential Organ Failure Assessment score from admission to 4th day.
Lymphocyte count1-4 daysChange in Lymphocyte count from admission to 4th day
invasive mechanical ventilation requirement1-28 daysinvasive mechanical ventilation requirement

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026