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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04264533
Recruitment Status : Terminated (the study was started in the second half of the outbreak, and the number of qualifying COVID-19 patients decreased with the control of the epidemic so that we had to stop our trial before reaching the predefined sample size.)
First Posted : February 11, 2020
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
ZhiYong Peng, Zhongnan Hospital

Tracking Information
First Submitted Date  ICMJE February 4, 2020
First Posted Date  ICMJE February 11, 2020
Last Update Posted Date October 12, 2020
Actual Study Start Date  ICMJE February 14, 2020
Actual Primary Completion Date March 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2020)
Ventilation-free days [ Time Frame: on the day 28 after enrollment ]
days without ventilation support during 28 days after patients' enrollment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2020)
  • 28-days mortality [ Time Frame: on the day 28 after enrollment ]
    wether the patient survives
  • ICU length of stay [ Time Frame: on the day 28 after enrollment ]
    days of the patients staying in the ICU
  • Demand for first aid measuments [ Time Frame: on the day 28 after enrollment ]
    the rate of CPR
  • Vasopressor days [ Time Frame: on the day 28 after enrollment ]
    days of using vasopressors
  • Respiratory indexes [ Time Frame: on the day 10 and 28 after enrollment ]
    P O2/Fi O2 which reflects patients' respiratory function
  • Ventilator parameters [ Time Frame: on the day 10 and 28 after enrollment ]
    Ecmo or ventilator
  • APACHE II scores [ Time Frame: on the day 10 after enrollment ]
    Acute Physiology and Chronic Health Evaluation
  • SOFA scores [ Time Frame: on the day 10 after enrollment ]
    Sepsis-related Organ Failure Assessment
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2020)
  • 28-days mortality [ Time Frame: on the day 28 after enrollment ]
    wether the patient survives
  • ICU length of stay [ Time Frame: on the day 28 after enrollment ]
    days of the patients staying in the ICU
  • Demand for first aid measuments [ Time Frame: on the day 28 after enrollment ]
    t t the rate of CPR
  • Vasopressor days [ Time Frame: on the day 28 after enrollment ]
    days of using vasopressors
  • Respiratory indexes [ Time Frame: on the day 10 and 28 after enrollment ]
    P O2/Fi O2 which reflects patients' respiratory function
  • Ventilator parameters [ Time Frame: on the day 10 and 28 after enrollment ]
    Ecmo or ventilator
  • APACHE II scores [ Time Frame: on the day 10 after enrollment ]
    Acute Physiology and Chronic Health Evaluation
  • SOFA scores [ Time Frame: on the day 10 after enrollment ]
    Sepsis-related Organ Failure Assessment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin C Infusion for the Treatment of Severe 2019-nCoV Infected Pneumonia
Official Title  ICMJE Vitamin C Infusion for the Treatment of Severe 2019-nCoV Infected Pneumonia: a Prospective Randomized Clinical Trial
Brief Summary

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.

Detailed Description

At the end of 2019, patients with unexplained pneumonia appeared in Wuhan, China. At 21:00 on January 7, 2020, a new coronavirus was detected in the laboratory, and the detection of pathogenic nucleic acids was completed at 20:00 on January 10. Subsequently, the World Health Organization officially named the new coronavirus that caused the pneumonia epidemic in Wuhan as 2019 new coronavirus (2019-nCoV), and the pneumonia was named severe acute respiratory infection (SARI). Up to February 4, 2020, over 20000 cases have been diagnosed in China, 406 of which have died, and 154 cases have been discovered in other countries around the world. Most of the deaths were elderly patients or patients with severe underlying diseases. SARI has caused global concern and emergency.

Statistics of the 41 patients with SARI published in JAMA initially showed that 13 patients were transferred into the ICU, of which 11 (85%) had ARDS and 3 (23%) had shock. Of these, 10 (77%) required mechanical ventilation support, and 2 (15%) required ECMO support. Of the above 13 patients, 5 (38%) eventually died and 7 (38%) were transferred out of the ICU. Viral pneumonia is a dangerous condition with a poor clinical prognosis. For most viral infections, there is a lack of effective targeted antiviral drugs, and symptomatic supportive treatment is still the current main treatment.

Vitamin C, also known as ascorbic acid, has antioxidant properties. When sepsis happens, the cytokine surge caused by sepsis is activated, and neutrophils in the lungs accumulate in the lungs, destroying alveolar capillaries. Early clinical studies have shown that vitamin C can effectively prevent this process. In addition, vitamin C can help to eliminate alveolar fluid by preventing the activation and accumulation of neutrophils, and reducing alveolar epithelial water channel damage. At the same time, vitamin C can prevent the formation of neutrophil extracellular traps, which is a biological event of vascular injury caused by neutrophil activation. Vitamins can effectively shorten the duration of the common cold. In extreme conditions (athletes, skiers, art workers, military exercises), it can effectively prevent the common cold. And whether vitamin C also has a certain protective effect on influenza patients, only few studies have shown that vitamin C deficiency is related to the increased risk and severity of influenza infections. In a controlled but non-randomized trial, 85% of the 252 students treated experienced a reduction in symptoms in the high-dose vitamin C group (1g / h at the beginning of symptoms for 6h, followed by 3 * 1g / day). Among patients with sepsis and ARDS, patients in the high-dose vitamin group did not show a better prognosis and other clinical outcomes. There are still some confounding factors in the existing research, and the conclusions are different.

Therefore, during the current epidemic of SARI, it is necessary to study the clinical efficacy and safety of vitamin C for viral pneumonia through randomized controlled trials.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Vitamin C
  • Pneumonia, Viral
  • Pneumonia, Ventilator-Associated
Intervention  ICMJE
  • Drug: VC
    12g Vitamin C will be infused in the experimental group twice a day for 7 days by the infusion pump with a speed of 12ml/h.
    Other Name: Vitamin C
  • Drug: Sterile Water for Injection
    50ml sterile water for injection will be infused in the placebo comparator group twice a day for 7 days by the infusion pump with a speed of 12ml/h.
Study Arms  ICMJE
  • Experimental: VC
    12g Vitamin C+sterile water for injection; total volume: 50ml. 12ml/h; infusion pump;q12h.
    Intervention: Drug: VC
  • Placebo Comparator: Sterile water for injection
    50ml water for injection. 12ml/h; infusion pump; q12h.
    Intervention: Drug: Sterile Water for Injection
Publications * Liu F, Zhu Y, Zhang J, Li Y, Peng Z. Intravenous high-dose vitamin C for the treatment of severe COVID-19: study protocol for a multicentre randomised controlled trial. BMJ Open. 2020 Jul 8;10(7):e039519. doi: 10.1136/bmjopen-2020-039519.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 8, 2020)
56
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2020)
140
Actual Study Completion Date  ICMJE March 29, 2020
Actual Primary Completion Date March 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. ≥ 18 years old;
  2. Diagnosed as serious or critical SARI (according to the 4th version of Diagnosis and Clinical management of 2019-nCoV infected pneumonia);
  3. Being treated in the ICU.

Exclusion Criteria:

  1. Allergic to vitamin C;
  2. Dyspnea due to cardiogenic pulmonary edema;
  3. Pregnant or breastfeeding;
  4. Expected life is less than 24 hours;
  5. There is a state of tracheotomy or home oxygen therapy in the past;
  6. Previously complicated with end-stage lung disease, end-stage malignancy, glucose-6-phosphate dehydrogenase deficiency, diabetic ketoacidosis, and active kidney stone disease;
  7. The patient participates in another clinical trial at the same time.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04264533
Other Study ID Numbers  ICMJE 2020001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ZhiYong Peng, Zhongnan Hospital
Study Sponsor  ICMJE ZhiYong Peng
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zhiyong Peng, professor Wuhan University
PRS Account Zhongnan Hospital
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP