Status:
COMPLETED
Efficacy and Safety of High-dose Vitamin C Combined With Chinese Medicine Against Coronavirus Pneumonia (COVID-19)
Lead Sponsor:
Xi'an International Medical Center Hospital
Conditions:
COVID-19
Eligibility:
All Genders
18-70 years
Phase:
NA
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 a...
Detailed Description
Preparation prior to treatment 1. Record of age, sex, race, height, body mass, body mass index, body temperature, blood pressure, pulse, and respiratory rate; 2. Record of previous medical history, c...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04664010
Start Date
February 6 2020
End Date
September 14 2023
Last Update
September 21 2023
Active Locations (1)
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1
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, China, 710100