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

NCT04264533 | Terminated Phase 2

• 1 other identifier: 2020001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Vitamin C; 2019-novel coronavirus pneumonia; Severe acute respiratory infection

Outcome Measures

Primary Outcomes (1)

• Ventilation-free days

  days without ventilation support during 28 days after patients' enrollment

  on the day 28 after enrollment

Secondary Outcomes (8)

• 28-days mortality

  on the day 28 after enrollment

• ICU length of stay

  on the day 28 after enrollment

• Demand for first aid measuments

  on the day 28 after enrollment

• Vasopressor days

  on the day 28 after enrollment

• Respiratory indexes

  on the day 10 and 28 after enrollment

Study Arms (2)

VC

EXPERIMENTAL

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

Drug: VC

Sterile water for injection

PLACEBO COMPARATOR

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

Drug: Sterile Water for Injection

Interventions

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.

Also known as: Vitamin C

VC

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.

Sterile water for injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ZhiYong Peng: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

Location

Related Publications (1)

• 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.

  PMID: 32641343 DERIVED

MeSH Terms

Conditions

Pneumonia, Viral; Pneumonia, Ventilator-Associated

Interventions

Ascorbic Acid; Injections

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Healthcare-Associated Pneumonia; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Zhiyong Peng, professor

  Wuhan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor; Chief physician

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 11, 2020
• Study Start: February 14, 2020
• Primary Completion: March 2, 2020
• Study Completion: March 29, 2020
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)