Vitamin CPhase 2NCT04264533
Vitamin C Infusion for the Treatment of Severe 2019-nCoV Infected Pneumonia
A Phase 2 study testing VC and Sterile Water for Injection in people with Vitamin C and Pneumonia, Viral, run by ZhiYong Peng at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin C, Pneumonia, Viral, Pneumonia, Ventilator-Associated
- What is being tested?
- VC and Sterile Water for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2020to 29 Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin C Infusion for the Treatment of Severe 2019-nCoV Infected Pneumonia: a Prospective Randomized Clinical Trial
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.
Read the 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.
- Being tested
- VC, Sterile Water for Injection
- Keywords
- Vitamin C, 2019-novel coronavirus pneumonia, Severe acute respiratory infection
- Medical subject headings
- Pneumonia, Viral, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCDrug
Also called Vitamin C
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.
Sterile Water for InjectionDrug
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 group | Role | What they receive |
|---|---|---|
| VC | Experimental | 12g Vitamin C+sterile water for injection; total volume: 50ml. 12ml/h; infusion pump;q12h. Receives: Drug: VC |
| Sterile water for injection | Placebo comparator | 50ml water for injection. 12ml/h; infusion pump; q12h. Receives: Drug: Sterile Water for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation-free days
days without ventilation support during 28 days after patients' enrollment
Measured: on the day 28 after enrollment
Secondary outcomes (8)
28-days mortality
wether the patient survives
Measured: on the day 28 after enrollment
ICU length of stay
days of the patients staying in the ICU
Measured: on the day 28 after enrollment
Demand for first aid measuments
the rate of CPR
Measured: on the day 28 after enrollment
Vasopressor days
days of using vasopressors
Measured: on the day 28 after enrollment
Respiratory indexes
P O2/Fi O2 which reflects patients' respiratory function
Measured: on the day 10 and 28 after enrollment
Ventilator parameters
Ecmo or ventilator
Measured: on the day 10 and 28 after enrollment
APACHE II scores
Acute Physiology and Chronic Health Evaluation
Measured: on the day 10 after enrollment
SOFA scores
Sepsis-related Organ Failure Assessment
Measured: on the day 10 after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start14 Feb 2020
- Primary completion2 Mar 2020
- Study completion29 Mar 2020
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZhiYong Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ZhiYong Peng, Zhongnan Hospital
- Investigators
- Zhiyong Peng, professor, Principal investigator, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264533
- Sponsor's protocol ID
- 2020001
- Status last verified
- Oct 2020
- First submitted
- 4 Feb 2020
- Last updated
- 12 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32641343
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin C Infusion for the Treatment of Severe 2019-nCoV Infected Pneumonia: a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04264533
- Acronym / sponsor ID
- 2020001
- Keywords
- Vitamin C, 2019-novel coronavirus pneumonia, Severe acute respiratory infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- ZhiYong PengUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 29 Mar 2020 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VC | Experimental | Drug: VC12g Vitamin C+sterile water for injection; total volume: 50ml. 12ml/h; infusion pump;q12h. |
| Sterile water for injection | Placebo comparator | Drug: Sterile Water for Injection50ml water for injection. 12ml/h; infusion pump; q12h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VCAlso: Vitamin C12g 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. | Drug | VC |
| Sterile Water for Injection50ml 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. | Drug | Sterile water for injection |
Primary outcome
Ventilation-free days
Time frame: on the day 28 after enrollment
days without ventilation support during 28 days after patients' enrollment
8 secondary outcomes
28-days mortality
Time frame: on the day 28 after enrollment
ICU length of stay
Time frame: on the day 28 after enrollment
Demand for first aid measuments
Time frame: on the day 28 after enrollment
Vasopressor days
Time frame: on the day 28 after enrollment
Respiratory indexes
Time frame: on the day 10 and 28 after enrollment
Ventilator parameters
Time frame: on the day 10 and 28 after enrollment
APACHE II scores
Time frame: on the day 10 after enrollment
SOFA scores
Time frame: on the day 10 after enrollment
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Derived from this study: PubMed 32641343Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiyong Peng, professor principal investigator
Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VC and Sterile Water for Injection in people with Vitamin C and Pneumonia, Viral, run by ZhiYong Peng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation-free days (time frame: on the day 28 after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04264533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.