Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VC | Experimental | 12g Vitamin C+sterile water for injection; total volume: 50ml. 12ml/h; infusion pumpï¼›q12h. |
|
| Sterile water for injection | Placebo Comparator | 50ml water for injection. 12ml/h; infusion pump; q12h. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VC | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ventilation-free days | days without ventilation support during 28 days after patients' enrollment | on the day 28 after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 28-days mortality | wether the patient survives | on the day 28 after enrollment |
| ICU length of stay | days of the patients staying in the ICU |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zhiyong Peng, professor | Wuhan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | 430000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32641343 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D007267 | Injections |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sterile Water for Injection | Drug | 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. |
|
| on the day 28 after enrollment |
| Demand for first aid measuments | the rate of CPR | on the day 28 after enrollment |
| Vasopressor days | days of using vasopressors | on the day 28 after enrollment |
| Respiratory indexes | P O2/Fi O2 which reflects patients' respiratory function | on the day 10 and 28 after enrollment |
| Ventilator parameters | Ecmo or ventilator | on the day 10 and 28 after enrollment |
| APACHE II scores | Acute Physiology and Chronic Health Evaluation | on the day 10 after enrollment |
| SOFA scores | Sepsis-related Organ Failure Assessment | on the day 10 after enrollment |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |