Objective:

2

To evaluate the efficacy and safety of Huashi Baidu Granules (HSBD) in treating patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant.

Methods:

2

A single-center retrospective cohort study was conducted during COVID-19 Omicron epidemic in the Mobile Cabin Hospital of Shanghai New International Expo Center from April 1st to May 23rd

2022. All COVID-19 patients with asymptomatic or mild infection were assigned to the treatment group (HSBD users) and the control group (non-HSBD users). After propensity score matching in a 1:1 ratio

496 HSBD users of treatment group were matched by propensity score to 496 non-HSBD users. Patients in the treatment group were administrated HSBD (5 g/bag) orally for 1 bag twice a day for 7 consecutive days. Patients in the control group received standard care and routine treatment. The primary outcomes were the negative conversion time of nucleic acid and negative conversion rate at day 7. Secondary outcomes included the hospitalized days

the time of the first nucleic acid negative conversion

and new-onset symptoms in asymptomatic patients. Adverse events (AEs) that occurred during the study were recorded. Further subgroup analysis was conducted in vaccinated (378 HSBD users and 390 non-HSBD users) and unvaccinated patients (118 HSBD users and 106 non-HSBD users).

Results:

2

The median negative conversion time of nucleic acid in the treatment group was significantly shortened than the control group [3 days (IQR: 2–5 days)

vs

. 5 days (IQR: 4–6 days);

P

<

0.01]. The negative conversion rate of nucleic acid in the treatment group were significantly higher than those in the control group at day 7 (91.73%

vs

. 86.90%

P

=0.014). Compared with the control group

the hospitalized days in the treatment group were significantly reduced [10 days (IQR: 8–11 days)

vs

. 11 days (IQR: 10.25–12 days);

P

<

0.01]. The time of the first nucleic acid negative conversion had significant differences between the treatment and control groups [3 days (IQR: 2–4 days)

vs

. 5 days (IQR: 4–6 days);

P

<

0.01]. The incidence of new-onset symptoms including cough

pharyngalgia

expectoration and fever in the treatment group were lower than the control group (

P

<

0.05 or

P

<

0.01). In the vaccinated patients

the median negative conversion time and hospitalized days were significantly shorter than the control group after HSDB treatment [3 days (IQR: 2–5 days)

vs

. 5 days (IQR: 4–6 days)

P

<

0.01; 10 days (IQR: 8–11 days)

vs

. 11 days (IQR: 10–12 days)

P

<

0.01]. In the unvaccinated patients

HSBD treatment efficiently shorten the median negative conversion time and hospitalized days [4 days (IQR: 2–6 days)

vs

. 5 days (IQR: 4–7 days)

P

<

0.01; 10.5 days (IQR: 8.75–11 days)

vs

. 11.0 days (IQR: 10.75–13 days);

P

<

0.01]. No serious AEs were reported during the study.

Conclusion:

2

HSBD treatment significantly shortened the negative conversion time of nuclear acid

the length of hospitalization

and the time of the first nucleic acid negative conversion in patients infected with SARS-COV-2 Omicron variant (Trial registry No. ChiCTR2200060472).