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Cochrane COVID-19 Study Register
Study record
NCT04264533First Published: 2020 Apr 1Updated Date: 2021 Jan 11

Vitamin C Infusion for the Treatment of Severe 2019-nCoV Infected Pneumonia: a Prospective Randomized Clinical Trial

  1. Study Type
  2. Interventional
  1. Study Aim
  2. Treatment and Management
  1. Study Design
  2. Parallel/Crossover
  1. Intervention Assignment
  2. Randomised
  1. Population (8)
  2. Male and Female
  3. Severe Acute Respiratory Infection
  4. Admission to Intensive Care Unit
  5. Adult
  6. Aged (65+)
  1. Intervention (1)
  2. Ascorbic Acid
  1. Comparison (1)
  2. Placebo
  1. Outcome (7)
  2. Length of ICU Stay
  3. Sepsis
  4. Finding Of Heart Rate
  5. Respiratory Function
  6. Mechanical ventilation
  7. Vasoconstrictor agents
  8. Survival
Reference record

Pilot trial of high-dose vitamin C in critically ill COVID-19 patients

Zhang J, Rao X, Li Y, Zhu Y, Liu F, Guo G, Luo G, Meng Z, De Backer D, Xiang H, Peng Z
Journal article(Zhang, Rao, Li, Zhu, Liu, Xiang, Peng) Dept. of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei 430071, China (Guo) Anti-Aging Medical Center, Taihe Hospital, Huibei University of Medicine, Shiyan, Hubei 442000, China (Luo) Department of Pulmonary and Critical Care Medicine, Taihe Hospital, Huibei University of Medicine, Shiyan, Hubei 442000, China (Meng) Department of Infectious Diseases, Taihe Hospital, Huibei University of Medicine, Shiyan, Hubei 442000, China (De Backer) Department of Intensive Care, CHIREC Hospitals, Universite Libre de Bruxelles, Brussels, Belgium (Zhang, Rao, Li, Xiang, Peng) Clinical Research Center of Hubei Critical Care Medicine, Wuhan, Hubei 430071, China
Report Results
BACKGROUND: Few specific medications have been proven effective for the treatment of patients with severe coronavirus disease 2019 (COVID-19). Here, we tested whether high-dose vitamin C infusion was effective for severe COVID-19. METHODS: This randomized, controlled, clinical trial was performed at 3 hospitals in Hubei, China. Patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the ICU were randomly assigned in as 1:1 ratio to either the high-dose intravenous vitamin C (HDIVC) or the placebo. HDIVC group received 12 g of vitamin C/50 ml every 12 h for 7 days at a rate of 12 ml/hour, and the placebo group received bacteriostatic water for injection in the same way within 48 h of arrival to ICU. The primary outcome was invasive mechanical ventilation-free days in 28 days (IMVFD28). Secondary outcomes were 28-day mortality, organ failure (Sequential Organ Failure Assessment (SOFA) score), and inflammation progression (interleukin-6). RESULTS: Only 56 critical COVID-19 patients were ultimately recruited due to the early control of the outbreak. There was no difference in IMVFD28 between two groups (26.0 [9.0-28.0] in HDIVC vs 22.0 [8.50-28.0] in control, p = 0.57). HDIVC failed to reduce 28-day mortality (P = 0.27). During the 7-day treatment period, patients in the HDIVC group had a steady rise in the PaO2/FiO2 (day 7: 229 vs. 151 mmHg, 95% CI 33 to 122, P = 0.01), which was not observed in the control group. IL-6 in the HDIVC group was lower than that in the control group (19.42 vs. 158.00; 95% CI -301.72 to -29.79; P = 0.04) on day 7. CONCLUSION: This pilot trial showed that HDIVC failed to improve IMVFD28, but might show a potential signal of benefit in oxygenation for critically ill patients with COVID-19 improving PaO2/FiO2 even though
Reference record

Vitamin C Infusion for the Treatment of Severe 2019-nCoV Infected Pneumonia

Zhongnan Hospital
First Published (first received 2020 February 11)ClinicalTrials.gov (https://clinicaltrials.gov/show/NCT04264533)
Trial registry record
No Results
2019 new coronavirus (2019-nCoV) infected pneumonia, namely severe acute respiratory infection (SARI) has caused global concern and emergency. There is a lack of effective targeted antiviral drugs, and symptomatic supportive treatment is still the current main treatment for SARI. Vitamin C is significant to human body and plays a role in reducing inflammatory response and preventing common cold. In addtion, a few studies have shown that vitamin C deficiency is related to the increased risk and severity of influenza infections. We hypothize that Vitamin C infusion can help improve the prognosis of patients with SARI. Therefore, it is necessary to study the clinical efficacy and safety of vitamin C for the clinical management of SARI through randomized controlled trials during the current epidemic of SARI
Reference record

Intravenous high-dose vitamin C for the treatment of severe COVID-19: study protocol for a multicentre randomised controlled trial

Liu F, Zhu Y, Zhang J, Li Y, Peng Z
Journal article(Liu, Zhu, Zhang, Li, Peng) Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
No Results
INTRODUCTION: The rapid worldwide spread of COVID-19 has caused a global health crisis. To date, symptomatic supportive care has been the most common treatment. It has been reported that the mechanism of COVID-19 is related to cytokine storms and subsequent immunogenic damage, especially damage to the endothelium and alveolar membrane. Vitamin C (VC), also known as L-ascorbic acid, has been shown to have antimicrobial and immunomodulatory properties. A high dose of intravenous VC (HIVC) was proven to block several key components of cytokine storms, and HIVC showed safety and varying degrees of efficacy in clinical trials conducted on patients with bacterial-induced sepsis and acute respiratory distress syndrome (ARDS). Therefore, we hypothesise that HIVC could be added to the treatment of ARDS and multiorgan dysfunction related to COVID-19. METHODS AND ANALYSIS: The investigators designed a multicentre prospective randomised placebo-controlled trial that is planned to recruit 308 adults diagnosed with COVID-19 and transferred into the intensive care unit. Participants will randomly receive HIVC diluted in sterile water or placebo for 7 days once enrolled. Patients with a history of VC allergy, end-stage pulmonary disease, advanced malignancy or glucose-6-phosphate dehydrogenase deficiency will be excluded. The primary outcome is ventilation-free days within 28 observational days. This is one of the first clinical trials applying HIVC to treat COVID-19, and it will provide credible efficacy and safety data. We predict that HIVC could suppress cytokine storms caused by COVID-19, help improve pulmonary function and reduce the risk of ARDS of COVID-19. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of Zhongnan Hospital of Wuhan University (identifiers: Clinical Ethical Approval No. 2020001). Findings of the trial will be disseminated through peer-reviewed journals and scientific conferences. TRIAL REGISTRATION NUMBER: NCT04264533