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

Primary Purpose

Vitamin C, Pneumonia, Viral, Pneumonia, Ventilator-Associated

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
VC
Sterile Water for Injection
Sponsored by
ZhiYong Peng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin C focused on measuring Vitamin C, 2019-novel coronavirus pneumonia, Severe acute respiratory infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongnan Hospital of Wuhan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VC

Sterile water for injection

Arm Description

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

50ml water for injection. 12ml/h; infusion pump; q12h.

Outcomes

Primary Outcome Measures

Ventilation-free days
days without ventilation support during 28 days after patients' enrollment

Secondary Outcome Measures

28-days mortality
wether the patient survives
ICU length of stay
days of the patients staying in the ICU
Demand for first aid measuments
the rate of CPR
Vasopressor days
days of using vasopressors
Respiratory indexes
P O2/Fi O2 which reflects patients' respiratory function
Ventilator parameters
Ecmo or ventilator
APACHE II scores
Acute Physiology and Chronic Health Evaluation
SOFA scores
Sepsis-related Organ Failure Assessment

Full Information

First Posted
February 4, 2020
Last Updated
October 8, 2020
Sponsor
ZhiYong Peng
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1. Study Identification

Unique Protocol Identification Number
NCT04264533
Brief Title
Vitamin C Infusion for the Treatment of Severe 2019-nCoV Infected Pneumonia
Official Title
Vitamin C Infusion for the Treatment of Severe 2019-nCoV Infected Pneumonia: a Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
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.
Study Start Date
February 14, 2020 (Actual)
Primary Completion Date
March 2, 2020 (Actual)
Study Completion Date
March 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ZhiYong Peng

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin C, Pneumonia, Viral, Pneumonia, Ventilator-Associated
Keywords
Vitamin C, 2019-novel coronavirus pneumonia, Severe acute respiratory infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VC
Arm Type
Experimental
Arm Description
12g Vitamin C+sterile water for injection; total volume: 50ml. 12ml/h; infusion pump;q12h.
Arm Title
Sterile water for injection
Arm Type
Placebo Comparator
Arm Description
50ml water for injection. 12ml/h; infusion pump; q12h.
Intervention Type
Drug
Intervention Name(s)
VC
Other Intervention Name(s)
Vitamin C
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sterile Water for Injection
Intervention Description
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 Measure Information:
Title
Ventilation-free days
Description
days without ventilation support during 28 days after patients' enrollment
Time Frame
on the day 28 after enrollment
Secondary Outcome Measure Information:
Title
28-days mortality
Description
wether the patient survives
Time Frame
on the day 28 after enrollment
Title
ICU length of stay
Description
days of the patients staying in the ICU
Time Frame
on the day 28 after enrollment
Title
Demand for first aid measuments
Description
the rate of CPR
Time Frame
on the day 28 after enrollment
Title
Vasopressor days
Description
days of using vasopressors
Time Frame
on the day 28 after enrollment
Title
Respiratory indexes
Description
P O2/Fi O2 which reflects patients' respiratory function
Time Frame
on the day 10 and 28 after enrollment
Title
Ventilator parameters
Description
Ecmo or ventilator
Time Frame
on the day 10 and 28 after enrollment
Title
APACHE II scores
Description
Acute Physiology and Chronic Health Evaluation
Time Frame
on the day 10 after enrollment
Title
SOFA scores
Description
Sepsis-related Organ Failure Assessment
Time Frame
on the day 10 after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 18 years old; Diagnosed as serious or critical SARI (according to the 4th version of Diagnosis and Clinical management of 2019-nCoV infected pneumonia); Being treated in the ICU. Exclusion Criteria: Allergic to vitamin C; Dyspnea due to cardiogenic pulmonary edema; Pregnant or breastfeeding; Expected life is less than 24 hours; There is a state of tracheotomy or home oxygen therapy in the past; Previously complicated with end-stage lung disease, end-stage malignancy, glucose-6-phosphate dehydrogenase deficiency, diabetic ketoacidosis, and active kidney stone disease; The patient participates in another clinical trial at the same time.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiyong Peng, professor
Organizational Affiliation
Wuhan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32641343
Citation
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.
Results Reference
derived

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

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