Efficacy and Safety of High-dose Vitamin C Combined With Chinese Medicine Against Coronavirus Pneumonia (COVID-19)

NCT04664010 | Completed

• 1 other identifier: XianInternationalMCH_HXJ
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In December 2019, coronavirus pneumonia (COVID-19) was detected in many cases in Wuhan, China. With the rapid spread of the coronavirus, cases of COVID-19 were also reported in other cities of China and other countries. COVID-19 can cause amplification of the pulmonary inflammatory responses, including the production of a large amount of free radicals and the release of inflammatory factors, in a short time after infection, leading to lung tissue damage and dysfunction, even resulting in life-threatening respiratory distress syndrome and respiratory failure. At present, there are no effective drugs targeting COVID-19. Previous studies have shown that Buzhong Yiqi Decoction has anti-bacterial, anti-viral, and anti-allergy effects. High-dose vitamin C also has anti-oxidative and anti-toxin effects, possibly exhibiting good effects in the treatment of viral infection and critical respiratory diseases. The study objectives include (1) investigate whether Buzhong Yiqi Decoction can improve the clinical symptoms of patients with mild and severe COVID-19 and accelerate recovery and to further investigate the clinical efficacy of high-dose vitamin C combined with traditional Chinese medicine in the treatment of mild and severe COVID-19; (2) to assess the safety of high-dose vitamin C combined with Chinese medicine in the treatment of mild and severe COVID-19.

Conditions

COVID-19

Keywords

COVID-19; vitamin C; traditional Chinese medicine

Outcome Measures

Primary Outcomes (1)

• Recovery time

  The discharge criteria of Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7) are applied: a) body temperature is back to normal for more than three days; b) respiratory symptoms improve obviously; c) pulmonary imaging shows obvious resolution of inflammation; d) nuclei acid tests negative twice consecutively on respiratory tract samples such as sputum and nasopharyngeal swabs (sampling interval being at least 24 hours)

  From date of randomization until the date of discharge, assessed up to 6 months

Secondary Outcomes (15)

• Time of disappearance of fever symptoms

  From date of randomization until the date of discharge, assessed up to 6 months

• The rate of conversion from COVID-19 positive to COVID-19 negative

  From date of randomization until the date of discharge, assessed up to 6 months.

• Time of disappearance of cough

  From date of randomization until the date of discharge, assessed up to 6 months

• Respiratory rate

  1-14 days after treatment

• Blood oxygen saturation

  1-14 days after treatment

Other Outcomes (1)

• Ultrasound examination of the urinary system

  1-14 days after treatment

Study Arms (6)

moderate COVID-19 group

EXPERIMENTAL

patients with moderate COVID-19 receiving western medicine treatment

Drug: Alpha-interferon alpha, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste, fumigation/inhalation of vitamin C

severe COVID-19 group

EXPERIMENTAL

patients with severe COVID-19 receiving western medicine treatment

Drug: Alpha-interferon alpha, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste, fumigation/inhalation of vitamin C

moderate COVID-19 with traditional Chinese medicine group

EXPERIMENTAL

patients with moderate COVID-19 receiving western medicine treatment + traditional Chinese medicine + intravenous administration of 5% glucose

Drug: Alpha-interferon, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste and 5% glucose

moderate COVID-19 with combination therapy group

EXPERIMENTAL

patients with moderate COVID-19 receiving western medicine treatment + traditional Chinese medicine + intravenous administration of 5% glucose containing high-dose vitamin C

Drug: Alpha-interferon, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste and 5% glucose

severe COVID-19 with traditional Chinese medicine group

EXPERIMENTAL

patients with severe COVID-19 receiving western medicine treatment + traditional Chinese medicine + intravenous administration of 5% glucose

Drug: Alpha-interferon, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste and high-dose vitamin C treatment

severe COVID-19 with combination therapy group

EXPERIMENTAL

patients with severe COVID-19 receiving western medicine treatment + traditional Chinese medicine + intravenous administration of 5% glucose containing high-dose vitamin C

Drug: Alpha-interferon, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste and high-dose vitamin C treatment

Interventions

Alpha-interferon alpha, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste, fumigation/inhalation of vitamin C DRUG

Atomized inhalation of 5 million U α-interferon and 2 mL sterilized water, twice a day; 0.2 g arbidol, three times a day, treatment course no more than 10 days; intravenous administration of ribavirin 500 mg, once every 12 hours, treatment course no more than 10 days; intravenous administration of 10 g immunoglobulin C, once a day, 3-5 days. Anti-bacterial infection treatment is given to the patients who have yellow sputum and increased levels of procalcitonin and other bacterial infection specific indicators.

Also known as: Western medicine treatment

moderate COVID-19 group; severe COVID-19 group

Alpha-interferon, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste and 5% glucose DRUG

Buzhong Yiqi plus and minus formula: 1 dose once, twice a day, taking with warm water. Huhuang Detoxicity Paste: One dose once, twice a day, taking with warm water; Baimu Qingre Jiedu Paste: One dose once, twice a day, taking with warm water; Fumigation/inhalation of Chinese herbs and vitamin C: 30-40 minutes once, 3-7 times a day. Patients take vitamin E capsule and folic acid every day. plus invention 1

Also known as: Traditional Chinese medicine treatment plus Western medicine treatment

moderate COVID-19 with combination therapy group; moderate COVID-19 with traditional Chinese medicine group

Alpha-interferon, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste and high-dose vitamin C treatment DRUG

invention 1 plus invention 2 plus 100 mL of 5% glucose containing vitamin C (10 g/60 kg body mass) is intravenously administered twice a day.

Also known as: Traditional Chinese medicine treatment plus Western medicine treatment plus Bolus administration of vitamin C

severe COVID-19 with combination therapy group; severe COVID-19 with traditional Chinese medicine group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with mild and severe COVID-19 confirmed according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7) that was issued by the National Health Commission \& State Administration of Traditional Chinese Medicine;
• Patients with suspected COVID-19 who meet one of the following pathogenic or serological evidence are also confirmed infected with the virus: a) COVID-19 nucleic acid test positive, as confirmed by real-time fluorescence RT-PCR detection; b) viral gene sequencing is highly homologous with the known COVID-19; c) serum test positive for both COVID-19 specific IgM and IgG antibodies; d) serum IgG antibody turns positive from negative or IgG antibody level in the recovering phase rises four times or higher than in the acute phase
• Patients with moderate COVID-19 have fever and respiratory symptoms and present with the imaging features of coronavirus disease
• Subjects will be considered developing severe COVID-19 if one of the following conditions occur: a) dyspnea, respiratory ≥ 30 beats/minute, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen (PaO2)/ fraction of inspired oxygen ratio (FiO2) ≤ 300, and /or lung infiltrates \> 50% within 24 to 48 hours
• Age \> 18 years, of either sex Provision of written informed consent

You may not qualify if:

• Patients with critical COVID-19 presenting with shock, acute respiratory distress syndrome, multiple organ failure
• Patients with mild COVID-19
• Pregnant or lactating woman
• Upon the investigator's judgment, patients had the diseases that possibly influence patient participation in this study or study outcomes (such as malignant disease, autoimmune disease, severe malnutrition, liver and kidney disease, blood disease, nervous system disease, endocrine diseases) or currently suffer from the diseases that seriously affect the immune system (such as human immunodeficiency virus infection) or blood system, or splenectomy/organ transplantation.
• Upon the request of the investigators or sponsors, patients with other acute malignant or chronic disease or mental disorder are not suitable for participation in this study.

Sponsors & Collaborators

• Xi'an International Medical Center Hospital: lead

Study Sites (1)

Xi'an International Medical Center Hospital

Xi'an, Shaanxi, 710100, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

Interferon-alpha; abidol; Ribavirin; Fumigation; Glucose

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Xijing He, MD

  Xi'an International Medical Center Hospital

  STUDY CHAIR

• Yongping Liu

  Xi'an International Medical Center Hospital

  PRINCIPAL INVESTIGATOR

• Xudong Yang

  Xi'an International Medical Center Hospital

  PRINCIPAL INVESTIGATOR

• Yali Wang

  Xi'an International Medical Center Hospital

  PRINCIPAL INVESTIGATOR

• Yifan Feng

  Xi'an International Medical Center Hospital

  PRINCIPAL INVESTIGATOR

• Kuiwei Zhang

  Xi'an International Medical Center Hospital

  PRINCIPAL INVESTIGATOR

• Jiayue Shan

  Xi'an International Medical Center Hospital

  PRINCIPAL INVESTIGATOR

• Lei Shang

  Xi'an International Medical Center Hospital

  PRINCIPAL INVESTIGATOR

• Zhijian Cheng

  Second Affiliated Hospital of Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

• Rui Wang

  Second Affiliated Hospital of Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

• Guoyu Wang

  Second Affiliated Hospital of Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

• Hui Gao

  Xi'an International Medical Center Hospital

  PRINCIPAL INVESTIGATOR

• Shanjiao Jiang

  Xi'an International Medical Center Hospital

  PRINCIPAL INVESTIGATOR

• Shenhao Liu

  Xi'an International Medical Center Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Blinding and blinding maintenance (1)The biostatisticians and the personnel unrelated to the clinical trial complete the binding of the study drugs and emergency card preparation. The random coding table and corresponding parameters are recorded blindly. After drug designation, the personnel responsible for blinding of the study drugs will sign at the perforation of the blinding envelope. A two-level blinding design will be adopted. The first-level code corresponds to intervention A or intervention B, and the second-level code presents the corresponding group. The envelope containing two-level blinding file will be preserved in Tianjin Angsai Cell Gene Engineering Co., Ltd., China until unblinding. The unblinding will not be performed during the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Model Details: participants are assigned to one of two or more groups in parallel for the duration of the study

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 11, 2020
• Study Start: February 6, 2020
• Primary Completion: September 14, 2022
• Study Completion: September 14, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)