Pneumonia Caused by Human Coronavirus (Disorder)
Conditions
Brief summary
The aim of this study is to test whether Traditional Chinese Medicines (TCMs) are effective and safe for treating COVID-19 infection. After the enrolment of approximately 30 subjects, the recruitment will be paused, and planned interim analysis will be performed to preliminarily investigate the efficacy and safety of TCMs in patients infected with COVID-19.
Detailed description
In December 2019, a cluster of patients with pneumonia in Wuhan, China, was caused by a novel betacoronavirus, which named the 2019 novel coronavirus (COVID-19). It was frequently reported that COVID-19 could be a public health crisis with high infectiousness, and it naturally spread across the country. Most of patients with COVID-19 infection were found to have non-specific symptoms including fever, cough, myalgia and fatigue. In addition, some patients were more likely to develop severe respiratory illness similar to severe acute respiratory syndrome (SARS), or even die. However, there was no timely and effective treatment of patients with COVID-19 infection. Traditional Chinese medicines (TCMs), are derived from plants and usually incorporate one or more herbs as the basic drug(s) to treat the disease. An RCT was performed to investigate TCM was effective and safe for treating COVID-19 infection. Eligible subjects will be randomized in a 1:1 ratio, and 1 subject on conventional medicines and TCMs granules for every 1 subject on conventional medicines. According to recommendations for prevention and control of pneumonia cause by COVID-19 infection from China National Health Commission, conventional medicines involve oxygen therapy and antiviral therapy (alfa interferon via aerosol inhalation, and lopinavir/ritonavir, p.o). Additionally, planned interim analysis will be performed, because the prevention and control of COVID-19 infection might affect estimated enrollment.
Interventions
DRUGConventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir) and Traditional Chinese Medicines (TCMs) granules
Conventional medicines: oxygen therapy, antiviral therapy (alfa interferon via aerosol inhalation, and lopinavir/ritonavir, 400mg/100mg, p.o, bid) for 14 days. Traditional Chinese Medicines (TCMs) granules: 20g, p.o, bid, for 14 days.
DRUGConventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir)
Conventional medicines: oxygen therapy, antiviral therapy (alfa interferon via aerosol inhalation, and lopinavir/ritonavir, 400mg/100mg, p.o, bid) for 14 days.
Sponsors
Beijing 302 Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed COVID-19 infection case in term of laboratory evidence; * 80 years ≥ age ≥ 14years; * Within 72 hours after the onset of abnormalities shown by Chest radiology or several symptoms (fever and cough).
Exclusion criteria
* Age \< 14 years or \> 80 years; * Pregnant or lactating female; * One of the following items occurred at the enrollment: (i) respiratory failure necessitating mechanical ventilation; (ii) liver failure: total bilirubin ≥ 10mg/dL and/or severe coagulation disorders; (iii) renal function failure: although adequate circulating blood and cardiac output, urine ≤ 0.5ml/kg·h, Cr or BUN ≥ 1.5 times normal elevation; * Intake of Chinese medicinal herbs during the past 2 weeks; * Refused to sign an informed consent form prior to study participation; * Unwilling and unable to comply with protocol request.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidents of acute respiratory distress syndrome (ARDS) development | 14 days | The incidence rate of acute respiratory distress syndrome (ARDS) development |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The time to fever resolution rate | 14 days | Time to complete remission of fever in eligible subjects |
| Time to recovery of lung injury | 14 days | improvement of chest radiographic evidence indirectly reflects recovery in patients infected with COVID-19. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of subjects who die | 28 days | The rate of subject who die will be described. |
| The duration of respiratory support | 28 days | The duration of respiratory support including invasive and non-invasive mechanical ventilation |
| Rate of subjects receiving systematic corticosteroids | 28 days | The rate of subjects with severe 2019-nCoV infection who receive systematic corticosteroids will be described. |
| The length of hospital stays | 28 days | The length of hospital stays |
Countries
China
Contacts
Primary ContactRui-lin Wang, Dr.
Backup ContactJia-bo Wang, PD.
Outcome results
None listed