Efficacy and safety of high-dose vitamin C combined with traditional Chinese medicine in the treatment of moderate and severe novel coronavirus pneumonia (COVID-19)
- Conditions
- ovel Coronavirus Pneumonia (COVID-19)
- Registration Number
- ITMCTR2000003284
- Lead Sponsor
- Xi'an International Medical Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
1. 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;
2. 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;
3. Patients with moderate COVID-19 have fever and respiratory symptoms and present with the imaging features of coronavirus disease;
4. Subjects will be considered developing severe COVID-19 if one of the following conditions occur:
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
5. Aged > 18 years;
6. Provision of written informed consent.
(1) Patients with critical COVID-19 presenting with shock, acute respiratory distress syndrome, multiple organ failure;
(2) Patients with mild COVID-19;
(3) Pregnant or lactating woman;
(4) Upon the investigators 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;
(5) 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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recovery time;
- Secondary Outcome Measures
Name Time Method Change in immune indexes;The rate and time of disappearance of major symptoms;The rate of conversion from COVID-19 positive to COVID-19 negative;Laboratory test indicators;Blood gas analysis indexes;The time and rate of obvious improvement as shown on chest CT scans relative to admission;Ultrasound examination of the urinary system;