Official Title
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.

Terminated
Vitamin C
Pneumonia, Viral
Pneumonia, Ventilator-Associated

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.

Eligibility 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China

Zhiyong Peng, professor, Principal Investigator
Wuhan University

NCT Number
Keywords
vitamin C
2019-novel coronavirus pneumonia
Severe acute respiratory infection
MeSH Terms
Pneumonia
Pneumonia, Viral
Pneumonia, Ventilator-Associated