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Completed

NCT Number: NCT04710329

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sisli etfal training and resource hospital

Şişli, Istanbul, 34376, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ascorbic acid

Drug

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.

Primary outcomes

  1. short term mortality

    Time frame: days 1-28

    Incidence of mortality at 28 days by all causes

  2. Length of Intensive Care Unit Stay

    Time frame: up to 28 days

    Length of Intensive Care Unit Stay

Secondary outcomes

  1. vasopressor requirement

    Time frame: 1-28 days

    all types of vasopressor requirement in intensive care stay

  2. invasive mechanical ventilation requirement

    Time frame: 1-28 days

    invasive mechanical ventilation requirement

  3. PaO2/FiO2 ratio

    Time frame: 1-4 day

    Change in PaO2/FiO2 ratio from admission to 4th day

  4. C-reactive protein

    Time frame: 1-4 days

    Change in C-reactive protein from admission to 4th day

  5. procalcitonin

    Time frame: 1-4 days

    Change in procalcitonin from admission to 4th day

  6. Lymphocyte count

    Time frame: 1-4 days

    Change in Lymphocyte count from admission to 4th day

  7. ferritin

    Time frame: 1-4 days

    Change in ferritin from admission to 4th day

  8. SOFA

    Time frame: 1-4 days

    Change in Sequential Organ Failure Assessment score from admission to 4th day.

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 14, 2021
Registry last updated
Feb 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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