Abstract
Coronavirus disease 2019 (COVID-19) has become a global pandemic. Community and close contact exposures continue to drive the COVID-19 pandemic. There is no confirmed effective treatment for suspected cases and close contacts. Lianhuaqingwen (LH) capsules, a repurposed Chinese herbal product that is currently on the market, have proven effective for influenza and COVID-19. To determine the safety and efficacy of LH capsules for the prevention of COVID-19, we conducted a prospective open-label controlled trial of LH capsules on subjects who had close contact with people infected with COVID-19. Subjects received LH capsules (4 capsules, three times daily) or the usual medical observation for 14 days. The primary endpoint was the rate of positive nucleic acid tests of nasal and pharyngeal swabs during the quarantine medical observation period. We included 1976 patients, including 1101 in the treatment group and 875 in the control group. The rate of positive nucleic acid tests in the treatment group was significantly lower than that in the control group (0.27% vs. 1.14%, respectively; mean difference: −0.87%; 95% CI: −1.83 to −0.13; p=0.0174) during the quarantine medical observation period (14 days). Among subjects with different close contact states, there was no significant difference in the rate of positive nucleic acid test results among close contacts in the treatment group and the control group (6.45% vs. 11.43%, respectively; p=0.6762). Among secondary close contacts, the rate of positive nucleic acid tests in the treatment group was significantly lower than that in the control group (0.09% vs. 0.71%, respectively; p=0.0485). No serious adverse events were reported. Taken together, and in light of the safety and effectiveness profiles, these results show that LH capsules can be considered to prevent the progression of COVID-19 after close contact with an infected person. This trial is registered with ChiCTR2100043012.
Highlights
Coronavirus disease 2019 (COVID-19), a novel acute respiratory infectious disease, has been a major global public health event since 2019 [1]. rough more than one year of active prevention, control, and treatment, the epidemic in China has been effectively controlled, with only local sporadic cases in some areas and a few imported cases
In this prospective practical clinical trial, we enrolled 1976 close contacts of COVID-19 cases in Hebei Province. e research scheme was approved by the Ethics Committee of the Second Hospital of Hebei Medical University. e protocol was designed according to the Good Clinical Practice guidelines and e Declaration of Helsinki and was registered with the China Clinical Trial Registry website
A total of 1976 patients met the inclusion criteria, had good compliance and a mean medication duration of 14.0 days if they were in the treatment group, and had no serious protocol violations
Summary
Coronavirus disease 2019 (COVID-19), a novel acute respiratory infectious disease, has been a major global public health event since 2019 [1]. rough more than one year of active prevention, control, and treatment, the epidemic in China has been effectively controlled, with only local sporadic cases in some areas and a few imported cases. Rough more than one year of active prevention, control, and treatment, the epidemic in China has been effectively controlled, with only local sporadic cases in some areas and a few imported cases. At present, strengthening the prevention and control of nosocomial infection, reducing the occurrence of nosocomial infection as much as possible, and enabling the early identification and isolation of asymptomatic cases and confirmed cases are the top priorities for controlling the source of infection and reducing the incidence of disease [2]. To obtain epidemiological information, such as the incidence, exposure history, and contact history of COVID-19 cases, and to conduct effective screening, evaluation, and Evidence-Based Complementary and Alternative Medicine management of the close contacts of novel coronavirus pneumonia cases, the National Health Commission formulated the COVID-19 Prevention and Control Plan (Eighth Edition) [3]. Detailed instructions were provided for the management of close contacts of COVID-19 patients
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