Beneficial effects of Chinese patent medicine ZhengQi tablet on treating the mild COVID-19

Abstract Objectives: This study aimed to assess the effectiveness of a Chinese patent medicine called ZhengQi tablet in the treatment of mild COVID-19 patients. Methods: A prospective cohort trial was carried out in the mobile cabin hospital of City Footprint Hall in Shanghai ( ChiCTR2200058693 ). A total of 800 mild COVID-19 patients were enrolled in this clinical trial and assigned to receive 7 days of treatment with ZhengQi tablet (ZQT group) or TCM placebo (control group) by oral administration per day. The nucleic acid conversion rate of SARS-CoV-2 was the percentage of subjects who got two negative results of Nucleic Acid Amplification Tests (NAATs) at a 24-hour interval out of the total number. The primary clinical indicators included the nucleic acid conversion rate of SARS-CoV-2 and the incidence rate of common COVID-19. The secondary ones, including the time of negative conversion of SARS-CoV-2 RNA and the hospitalization duration were evaluated. Results: A total of 850 mild COVID-19 patients were recruited, and 800 patients were qualified to undergo the clinical trial, with 423 patients assigned for ZQT and 377 patients for TCM placebo. Finally, 390 patients in the ZQT group and 368 patients in the control group completed the follow-up assessments. The nucleic acid conversion rates in ZQT group at 2-day, 3-day and 4-day post-treatment were higher than that in the control group (27.9%vs.9.2%, P <0.001; 38.2%vs.16.6%, P <0.001; 45.4%vs.36.1%, P =0.010). There were no patients who developed into a severe disease. The median time of negative conversion in ZQT group was higher than that in the control group (4[2-6]vs.5[4-6]days, P =0.001). The median hospitalization durations were not different between ZQT group and the control group (5[3-7]vs.6[5-6]days , P =0.065). In terms of the improvement of clinical symptoms, the difference in diarrhea between two groups was statistically significant (100.0%vs.83.3%, P =0.026). There was no significant difference in the improvement of other clinical symptoms. No serious adverse events were reported in both groups. Conclusions: ZhengQi tablet showed beneficial effectiveness in treating patients with mild COVID-19 viaimproving the nucleic acid conversion rate of SARS-CoV-2 and shortening the time of negative conversion.