ABSTRACT
Background: As the coronavirus disease 2019 (COVID-19) pandemic progressed, especially with the emergence of the Omicron variant, the proportion of infected children and adolescents increased significantly. Some treatment such as Chinese herbal medicine has been administered for COVID-19 as a therapeutic option. Jin-Zhen Oral Liquid is widely used for pediatric acute bronchitis, while the efficacy and safety in the treatment of pediatric COVID-19 are unclear. Methods: We conducted a randomized controlled, open-label, multicenter, non-inferiority clinical study involving hospitalized children with mild to moderate COVID-19. Children eligible for enrollment were randomly assigned in a 1:1 ratio to Jin-Zhen Oral Liquid (the treatment group) and Jinhua Qinggan Granules (the positive control group) and received the respective agent for 14 days, followed by a 14-day follow-up after discontinuation of the treatment. The primary efficacy endpoint was the time to first negative viral testing. The secondary endpoints were the time and rate of major symptoms disappearance, duration of hospitalization, and the proportion of symptoms changed from asymptomatic or mild to moderate or severe/critical illness. In addition, the safety end points of any adverse events were observed. Results: A total of 240 child patients were assigned randomly into the Jin-Zhen Oral Liquid (117 patients) and Jinhua Qinggan Granules (123 patients) groups. There was no significant difference of the baselines in terms of the clinical characteristics and initial symptoms between the two groups. After 14-day administration, the time to first negative viral testing in the Jin-Zhen group (median 6.0 days, 95% CI 5.0-6.0) was significantly shorter compared with the positive control Jinhua Qinggan Granules group (median 7.0 days, 95% CI 7.0-8.0). The time and rate of major clinical symptoms disappearance were comparable to the positive control. The symptom disappearance time of pharyngalgia and hospitalization duration were significantly shortened in the Jin-zhen Oral Liquid group. No participants in either group experienced post-treatment exacerbation to severe or critical illness. No adverse events were observed in the Jin-Zhen Oral Liquid treatment group (0.0%) while 1 patient with adverse events occurred in the positive control Jinhua Qinggan granules group (0.8%). No serious adverse events were observed during the study period in both groups. Conclusion: Jin-Zhen Oral Liquid is safe and effective in the treatment of mild to medium COVID-19 in children. It is non-inferior to Jinhua Qinggan granules in shortening the time to first negative viral testing, the time and rate of major clinical symptoms disappearance, and the hospitalization duration. The results suggest that Jin-Zhen Oral Liquid can be a recommended drug for treatment of pediatric COVID-19 patients.
ABSTRACT
The new type of coronavirus pneumonia (COVID-19) is raging around the world, and the number of diagnoses and deaths continues to rise, and there is still no specific treatment drug. Chloroquine is a traditional medicine for the treatment of malaria and autoimmune diseases. It has shown initial efficacy in the treatment of COVID-19 and has attracted much attention. Hydroxychloroquine is a derivative of chloroquine, and its clinical drug safety is higher than that of chloroquine. It is listed by the World Health Organization as one of the 4 candidate trial drugs for the treatment of COVID-19 , Has also been included in the trial of the sixth and seventh editions of the COVID-19 treatment plan by the National Health Commission of China. However, the clinical efficacy of chloroquine and hydroxychloroquine in the treatment of COVID-19 is still very controversial, and sufficient Clinical data supports its use as a recommended drug for the treatment of COVID-19. In order to have a clearer understanding of chloroquine and hydroxychloroquine, this article briefly summarizes the pathological changes and treatment options of COVID-19, focusing on the efficacy of hydroxychloroquine in clinical trials and an in-depth analysis The potential causes and possible mechanisms of the different results of hydroxychloroquine in clinical trials, and the potential therapeutic effects of anisodamine and the antiviral drug remdesivir and psychological interventions are discussed, which are important for the rationalization of COVID-19 treatment options Reference value.