Treatment and Prevention of Traditional Chinese Medicines (TCMs) on COVID-19 Infection

Pneumonia Caused by Human Coronavirus (Disorder) Clinical Trial

Official title:

Effects of Traditional Chinese Medicines (TCMs) on Patients With COVID-19 Infection: A Perspective, Open-labeled, Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04251871
• Other study ID #: 2020001D
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2020
• Est. completion date: January 22, 2021

Study information

• Verified date: May 2020
• Source: Beijing 302 Hospital
• Contact: Rui-lin Wang, Dr.
• Phone: +86 10 66933436
• Email: wrl7905[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 22, 2021
• Est. primary completion date: January 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia Caused by Human Coronavirus (Disorder)

Intervention

Drug:
• Conventional 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.
• Conventional 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.

Locations

Country	Name	City	State
China	The Fifth Medical Center, General Hospital of PLA	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing 302 Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24. — View Citation

Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:. — View Citation

World Health Organization. Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected: interim guidance. Published January 28, 2020. Accessed January 31, 2020. https://www. who.int/publications-detail/clinical-managementof- severe-acute-respiratory-infection-when-novelcoronavirus-( ncov)-infection-is-suspected

Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of subjects who die	The rate of subject who die will be described.	28 days
Other	Rate of subjects receiving systematic corticosteroids	The rate of subjects with severe 2019-nCoV infection who receive systematic corticosteroids will be described.	28 days
Other	The length of hospital stays	The length of hospital stays	28 days
Other	The duration of respiratory support	The duration of respiratory support including invasive and non-invasive mechanical ventilation	28 days
Primary	The incidents of acute respiratory distress syndrome (ARDS) development	The incidence rate of acute respiratory distress syndrome (ARDS) development	14 days
Secondary	The time to fever resolution rate	Time to complete remission of fever in eligible subjects	14 days
Secondary	Time to recovery of lung injury	improvement of chest radiographic evidence indirectly reflects recovery in patients infected with COVID-19.	14 days