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Intravenous high-dose vitamin C for the treatment of severe COVID-19: study protocol for a multicentre randomised controlled trial
by
Zhu, Yuan
, Zhang, Jing
, Li, Yiming
, Peng, Zhiyong
, Liu, Fang
in
Administration, Intravenous
/ adult intensive & critical care
/ Ascorbic Acid - administration & dosage
/ Betacoronavirus
/ Biomarkers
/ China
/ Clinical trials
/ Coronaviruses
/ COVID-19
/ COVID-19 - complications
/ COVID-19 - immunology
/ COVID-19 Drug Treatment
/ Cytokine Release Syndrome - drug therapy
/ Cytokine Release Syndrome - immunology
/ Cytokines
/ Hospital Mortality
/ Humans
/ Immunomodulators
/ infectious diseases
/ Intensive Care
/ Intensive Care Units
/ Kinases
/ Multicenter Studies as Topic
/ Oxidative stress
/ Pandemics
/ Randomized Controlled Trials as Topic
/ Respiration, Artificial
/ respiratory infections
/ SARS-CoV-2
/ Sepsis
/ Severe acute respiratory syndrome coronavirus 2
/ Severity of Illness Index
/ Signal transduction
/ Treatment Outcome
/ Tumor necrosis factor-TNF
/ Ventilators
/ Vitamin C
/ Vitamins - administration & dosage
2020
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Intravenous high-dose vitamin C for the treatment of severe COVID-19: study protocol for a multicentre randomised controlled trial
by
Zhu, Yuan
, Zhang, Jing
, Li, Yiming
, Peng, Zhiyong
, Liu, Fang
in
Administration, Intravenous
/ adult intensive & critical care
/ Ascorbic Acid - administration & dosage
/ Betacoronavirus
/ Biomarkers
/ China
/ Clinical trials
/ Coronaviruses
/ COVID-19
/ COVID-19 - complications
/ COVID-19 - immunology
/ COVID-19 Drug Treatment
/ Cytokine Release Syndrome - drug therapy
/ Cytokine Release Syndrome - immunology
/ Cytokines
/ Hospital Mortality
/ Humans
/ Immunomodulators
/ infectious diseases
/ Intensive Care
/ Intensive Care Units
/ Kinases
/ Multicenter Studies as Topic
/ Oxidative stress
/ Pandemics
/ Randomized Controlled Trials as Topic
/ Respiration, Artificial
/ respiratory infections
/ SARS-CoV-2
/ Sepsis
/ Severe acute respiratory syndrome coronavirus 2
/ Severity of Illness Index
/ Signal transduction
/ Treatment Outcome
/ Tumor necrosis factor-TNF
/ Ventilators
/ Vitamin C
/ Vitamins - administration & dosage
2020
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Intravenous high-dose vitamin C for the treatment of severe COVID-19: study protocol for a multicentre randomised controlled trial
by
Zhu, Yuan
, Zhang, Jing
, Li, Yiming
, Peng, Zhiyong
, Liu, Fang
in
Administration, Intravenous
/ adult intensive & critical care
/ Ascorbic Acid - administration & dosage
/ Betacoronavirus
/ Biomarkers
/ China
/ Clinical trials
/ Coronaviruses
/ COVID-19
/ COVID-19 - complications
/ COVID-19 - immunology
/ COVID-19 Drug Treatment
/ Cytokine Release Syndrome - drug therapy
/ Cytokine Release Syndrome - immunology
/ Cytokines
/ Hospital Mortality
/ Humans
/ Immunomodulators
/ infectious diseases
/ Intensive Care
/ Intensive Care Units
/ Kinases
/ Multicenter Studies as Topic
/ Oxidative stress
/ Pandemics
/ Randomized Controlled Trials as Topic
/ Respiration, Artificial
/ respiratory infections
/ SARS-CoV-2
/ Sepsis
/ Severe acute respiratory syndrome coronavirus 2
/ Severity of Illness Index
/ Signal transduction
/ Treatment Outcome
/ Tumor necrosis factor-TNF
/ Ventilators
/ Vitamin C
/ Vitamins - administration & dosage
2020
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Intravenous high-dose vitamin C for the treatment of severe COVID-19: study protocol for a multicentre randomised controlled trial
Journal Article
Intravenous high-dose vitamin C for the treatment of severe COVID-19: study protocol for a multicentre randomised controlled trial
2020
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Overview
IntroductionThe 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 analysisThe 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 disseminationThe 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.
Publisher
British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ Publishing Group
Subject
/ adult intensive & critical care
/ Ascorbic Acid - administration & dosage
/ China
/ COVID-19
/ Cytokine Release Syndrome - drug therapy
/ Cytokine Release Syndrome - immunology
/ Humans
/ Kinases
/ Multicenter Studies as Topic
/ Randomized Controlled Trials as Topic
/ Sepsis
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