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Intravenous high-dose vitamin C for the treatment of severe COVID-19: study protocol for a multicentre randomised controlled trial.
Liu, Fang; Zhu, Yuan; Zhang, Jing; Li, Yiming; Peng, Zhiyong.
  • Liu F; Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.
  • Zhu Y; Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.
  • Zhang J; Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.
  • Li Y; Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.
  • Peng Z; Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China Pengzy5@hotmail.com.
BMJ Open ; 10(7): e039519, 2020 07 08.
Article in English | MEDLINE | ID: covidwho-639482
Semantic information from SemMedBD (by NLM)
1. Pharmacological Ascorbate TREATS COVID-19
Subject
Pharmacological Ascorbate
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TREATS
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COVID-19
2. Membrane PART_OF Alveolar
Subject
Membrane
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PART_OF
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Alveolar
3. COVID-19 COEXISTS_WITH Storm NOS
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COVID-19
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COEXISTS_WITH
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Storm NOS
4. Respiratory Distress Syndrom PROCESS_OF C0030705
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Respiratory Distress Syndrom
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PROCESS_OF
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C0030705
5. Bacterial sepsis PROCESS_OF Patients
Subject
Bacterial sepsis
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PROCESS_OF
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Patients
6. Respiratory Distress Syndrom COEXISTS_WITH C5203670
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Respiratory Distress Syndrom
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COEXISTS_WITH
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C5203670
7. Research Personnel DIAGNOSES COVID-19
Subject
Research Personnel
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DIAGNOSES
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COVID-19
8. Lung LOCATION_OF Terminal illness
Subject
Lung
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LOCATION_OF
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Terminal illness
9. COVID-19 AFFECTS Pulmonary function
Subject
COVID-19
Predicate
AFFECTS
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Pulmonary function
10. Pharmacological Ascorbate TREATS COVID-19
Subject
Pharmacological Ascorbate
Predicate
TREATS
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COVID-19
11. Membrane PART_OF Alveolar
Subject
Membrane
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PART_OF
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Alveolar
12. COVID-19 COEXISTS_WITH Storm NOS
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COVID-19
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Storm NOS
13. Respiratory Distress Syndrome, Adult PROCESS_OF Patients
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Respiratory Distress Syndrome, Adult
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PROCESS_OF
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Patients
14. Bacterial sepsis PROCESS_OF Patients
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Bacterial sepsis
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PROCESS_OF
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Patients
15. Respiratory Distress Syndrome, Adult COEXISTS_WITH COVID-19
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Respiratory Distress Syndrome, Adult
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COEXISTS_WITH
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COVID-19
16. Research Personnel DIAGNOSES COVID-19
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Research Personnel
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DIAGNOSES
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COVID-19
17. Lung LOCATION_OF Terminal illness
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Lung
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LOCATION_OF
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Terminal illness
18. COVID-19 AFFECTS Pulmonary function
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COVID-19
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Pulmonary function
ABSTRACT

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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Pneumonia, Viral / Ascorbic Acid / Vitamins / Coronavirus Infections / Cytokine Release Syndrome Subject: Pneumonia, Viral / Ascorbic Acid / Vitamins / Coronavirus Infections / Cytokine Release Syndrome Type of study: Controlled clinical trial / Ethical aspects / Etiology study / Clinical Practice Guide / Prognostic study Language: English Journal: BMJ Open Year: 2020

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Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Pneumonia, Viral / Ascorbic Acid / Vitamins / Coronavirus Infections / Cytokine Release Syndrome Subject: Pneumonia, Viral / Ascorbic Acid / Vitamins / Coronavirus Infections / Cytokine Release Syndrome Type of study: Controlled clinical trial / Ethical aspects / Etiology study / Clinical Practice Guide / Prognostic study Language: English Journal: BMJ Open Year: 2020
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