Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.


Condition or disease Intervention/treatment Phase
Vitamin C Pneumonia, Viral Pneumonia, Ventilator-Associated Drug: VC Drug: Sterile Water for Injection Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin C Infusion for the Treatment of Severe 2019-nCoV Infected Pneumonia: a Prospective Randomized Clinical Trial
Actual Study Start Date : February 14, 2020
Actual Primary Completion Date : March 2, 2020
Actual Study Completion Date : March 29, 2020


Arm Intervention/treatment
Experimental: VC
12g Vitamin C+sterile water for injection; total volume: 50ml. 12ml/h; infusion pump;q12h.
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

Placebo Comparator: Sterile water for injection
50ml water for injection. 12ml/h; infusion pump; q12h.
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.




Primary Outcome Measures :
  1. Ventilation-free days [ Time Frame: on the day 28 after enrollment ]
    days without ventilation support during 28 days after patients' enrollment


Secondary Outcome Measures :
  1. 28-days mortality [ Time Frame: on the day 28 after enrollment ]
    wether the patient survives

  2. ICU length of stay [ Time Frame: on the day 28 after enrollment ]
    days of the patients staying in the ICU

  3. Demand for first aid measuments [ Time Frame: on the day 28 after enrollment ]
    the rate of CPR

  4. Vasopressor days [ Time Frame: on the day 28 after enrollment ]
    days of using vasopressors

  5. Respiratory indexes [ Time Frame: on the day 10 and 28 after enrollment ]
    P O2/Fi O2 which reflects patients' respiratory function

  6. Ventilator parameters [ Time Frame: on the day 10 and 28 after enrollment ]
    Ecmo or ventilator

  7. APACHE II scores [ Time Frame: on the day 10 after enrollment ]
    Acute Physiology and Chronic Health Evaluation

  8. SOFA scores [ Time Frame: on the day 10 after enrollment ]
    Sepsis-related Organ Failure Assessment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04264533


Locations
Layout table for location information
China, Hubei
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430000
Sponsors and Collaborators
ZhiYong Peng
Investigators
Layout table for investigator information
Principal Investigator: Zhiyong Peng, professor Wuhan University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: ZhiYong Peng, Professor; Chief physician, Zhongnan Hospital
ClinicalTrials.gov Identifier: NCT04264533    
Other Study ID Numbers: 2020001
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ZhiYong Peng, Zhongnan Hospital:
Vitamin C
2019-novel coronavirus pneumonia
Severe acute respiratory infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia, Ventilator-Associated
Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Cross Infection
Infection