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

Launched by XI'AN INTERNATIONAL MEDICAL CENTER HOSPITAL · Dec 9, 2020

Keywords

ClinConnect Summary

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, current medical history, treatment history, concomitant disease/treatment history;
3. 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
4. Cytokine detection: Serum levels of interleukin-6, interleukin-10, and tumor necrosis...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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: 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
• • 5. Age \> 18 years, of either sex Provision of written informed consent
• Exclusion Criteria:
• • 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 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.
• • 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.