Clinical trial NCT04251871: Treatment and Prevention of Traditional Chinese Medicines (TCMs) on COVID-19 Infection
Official title: Effects of Traditional Chinese Medicines (TCMs) on Patients With COVID-19 Infection: A Perspective, Open-labeled, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pneumonia Caused by Human Coronavirus (Disorder)
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 150
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidents of acute respiratory distress syndrome (ARDS) development
timeFrame: 14 days
Secondary outcomes:
measure: The time to fever resolution rate
timeFrame: 14 days
measure: Time to recovery of lung injury
timeFrame: 14 days
Other outcomes:
measure: Rate of subjects who die
timeFrame: 28 days
measure: Rate of subjects receiving systematic corticosteroids
timeFrame: 28 days
measure: The length of hospital stays
timeFrame: 28 days
measure: The duration of respiratory support
timeFrame: 28 days
Locations:
city: Beijing
country: China
facility: The Fifth Medical Center, General Hospital of PLA
state: Beijing
Study officials:
affiliation: 302 Military Hospital
name: Xiao-he Xiao, PD.
role: STUDY_DIRECTOR
References:
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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
citation: Akhtar S, Das JK, Ismail T, Wahid M, Saeed W, Bhutta ZA. Nutritional perspectives for the prevention and mitigation of COVID-19. Nutr Rev. 2021 Feb 11;79(3):289-300. doi: 10.1093/nutrit/nuaa063.
citation: Wang JB, Wang ZX, Jing J, Zhao P, Dong JH, Zhou YF, Yang G, Niu M, Zhao X, Jiang TJ, Bi JF, Xu Z, Zhang P, Wu D, Bai ZF, Guo YM, Yu SM, Sun YQ, Zhang ZT, Zhan XY, Li PY, Ding JB, Zhao PF, Song XA, Tang JY, He DC, Chen Z, Qin EQ, Wang RL, Xiao XH. Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial. Chin J Integr Med. 2020 Sep;26(9):648-655. doi: 10.1007/s11655-020-3426-7. Epub 2020 Jul 16.