Objective:

2

To evaluate the effect and safety of Chinese medicine (CM) Fuzheng Huazhuo Decoction (FHD) in treating patients with coronavirus disease 2019 (COVID-19) who persistently tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Methods:

2

This retrospective cohort study was conducted at Shanghai New International Expo Center shelter hospital in China between April 1 and May 30

2022. Patients diagnosed as COVID-19 with persistently positive SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) test results for 8 days after diagnosis were enrolled. Patients in the control group received conventional Western medicine (WM) treatment

while those in the FHD group received conventional WM plus FHD for at least 3 days. The primary outcome was viral clearance time. Secondary outcomes included negative conversion rate within 14 days

length of hospital stay

cycle threshold (Ct) values of the open reading frame 1ab (ORF1ab) and nucleocapsid protein (N) genes

and incidence of new-onset symptoms during hospitalization. Adverse events (AEs) that occurred during the study period were recorded.

Results:

2

A total of 1

765 eligible patients were enrolled in this study (546 in the FHD group and 1

219 in the control group). Compared with the control group

patients receiving FHD treatment showed shorter viral clearance time for nucleic acids [hazard ratio (HR): 1.500

95% conf

idence interval (CI): 1.353–1.664

P

<

0.001

]

and hospital stays (HR: 1.371

95% CI: 1.238–1.519

P

<

0.001)

and a higher negative conversion rate within 14 days (96.2%

vs

. 82.6%

P

<

0.001). The incidence of new-onset symptoms was 59.5% in the FHD group

similar to 57.8% in the control group (

P

>

0.05). The Ct values of ORF1ab and N genes increased more rapidly over time in the FHD group than those in the control group post-randomization (ORF1ab gene:

β

=0.436±0.053

P

<

0.001; N gene:

β

=0.415±0.053

P

<

0.001). The incidence of AEs in the FHD group was lower than that in the control group (24.2%

vs

. 35.4%

P

<

0.001). No serious AEs were observed.

Conclusion:

2

FHD was effective and safe for patients with persistently positive SARS-CoV-2 PCR tests. (Registration No. ChiCTR2200063956)