Efficacy and Safety of High-dose Vitamin C Combined With Traditional Chinese Medicine in the Treatment of Moderate and Severe Coronavirus Pneumonia (COVID-19)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recovery time
研究概览
简要总结
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.
详细描述
Preparation prior to treatment
- Record of age, sex, race, height, body mass, body mass index, body temperature, blood pressure, pulse, and respiratory rate;
- Record of previous medical history, current medical history, treatment history, concomitant disease/treatment history;
- Record of laboratory tests: routine blood test, routine stool and urine tests, fecal occult blood test, C-reactive protein measurement, biochemical assay, PCR testing for respiratory virus, tumor marker test, and ABO typing
- Cytokine detection: Serum levels of interleukin-6, interleukin-10, and tumor necrosis factor-alpha (TNF-α)
- Auxiliary examination: Chest CT for assessment of lung infection
Chinese medicine treatments Chinese medicine treatments include oral administration of concentrated Chinese herbal decoction, fumigation/inhalation of Chinese medicine and vitamin C, and bolus administration of vitamin C.
Traditional Chinese and western medicine prescription details Traditional Chinese medicine treatment details Prescription 1: Buzhong Yiqi plus and minus formula (recommended for patients who had no fever and those who are in the convalescent period): This formula is composed of Radix Astragali 30 g, Radix Ginseng 15 g, Radix Glycyrrhizae 15 g, Rhizoma Atractylodis Macrocephalae 10 g, Pericarpium Citri Reticulatae 6 g, Radix Angelicae Sinensis 10 g, Fructus Jujubae 6, Rhizoma Zingiberis Recens 9 pieces, Radix Bupleuri 12 g, Rhizoma Cimicifugae 6 g.
Preparation method: The aforementioned herbs are decocted with water. After removal of macromolecules, 50 g concentrate is left, and then packaged, 25 g/dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
moderate COVID-19 group
patients with moderate COVID-19 receiving western medicine treatment
干预措施: Alpha-interferon alpha, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste, fumigation/inhalation of vitamin C (Drug)
severe COVID-19 group
patients with severe COVID-19 receiving western medicine treatment
干预措施: Alpha-interferon alpha, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste, fumigation/inhalation of vitamin C (Drug)
moderate COVID-19 with traditional Chinese medicine group
patients with moderate COVID-19 receiving western medicine treatment + traditional Chinese medicine + intravenous administration of 5% glucose
干预措施: Alpha-interferon, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste and 5% glucose (Drug)
moderate COVID-19 with combination therapy group
patients with moderate COVID-19 receiving western medicine treatment + traditional Chinese medicine + intravenous administration of 5% glucose containing high-dose vitamin C
干预措施: Alpha-interferon, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste and 5% glucose (Drug)
severe COVID-19 with traditional Chinese medicine group
patients with severe COVID-19 receiving western medicine treatment + traditional Chinese medicine + intravenous administration of 5% glucose
干预措施: Alpha-interferon, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste and high-dose vitamin C treatment (Drug)
severe COVID-19 with combination therapy group
patients with severe COVID-19 receiving western medicine treatment + traditional Chinese medicine + intravenous administration of 5% glucose containing high-dose vitamin C
干预措施: Alpha-interferon, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste and high-dose vitamin C treatment (Drug)
结局指标
主要结局
Recovery time
时间窗: From date of randomization until the date of discharge, assessed up to 6 months
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)
次要结局
- 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)
- PaO2(1-14 days after treatment)
- PaCO2(1-14 days after treatment)
- The time of obvious improvement as shown on chest CT scans relative to admission(From date of randomization until the date of discharge, assessed up to 6 months)
- The rate of obvious improvement as shown on chest CT scans relative to admission(From date of randomization until the date of discharge, assessed up to 6 months)
- Levels of C-reactive protein(1-14 days after treatment)
- Erythrocyte sedimentation rate(1-14 days after treatment)
- Levels of Procalcitonin(1-14 days after treatment)
- Levels of interleukin-6(1-14 days after treatment)
- Levels of interleukin-10(1-14 days after treatment)
- Levels of tumor necrosis factor-alpha(1-14 days after treatment)
研究者
Qiang Yin
President
Xi'an International Medical Center Hospital