Objective:

2

To assess the effect and safety of Reyanning Mixture (RYN) in treating asymptomatic or mild severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in children and adolescents.

Methods:

2

This is a prospective

open-label

randomized controlled trial. Patients aged 1–17 years and diagnosed with asymptomatic or mild coronavirus disease-2019 (COVID-19) were assigned to an intervention group (RYN plus standard care) and a control group (standard care) according to a randomization list. The primary outcomes were SARS-CoV-2 negative conversion time. Secondary outcomes included negative conversion rate on days 3 and 7

hospital length of stay

symptom relief rate

new-onset symptoms of asymptomatic infected patients

and progressive disease rate. The cycle threshold (Ct) values of ORF1ab or N genes were also tested.

Results:

2

A total of 214 patients in the intervention group and 217 in the control group were analyzed. The SARS-CoV-2 negative conversion time was significantly shortened in the intervention group [5 days (interquartile range (IQR): 5–6)

vs

. 7 days (IQR: 6–7)

P

<

0.01]. By days 3 and 7

the negative conversion rates were significantly higher in the intervention group (day 3: 32.7%

vs

. 21.2%

P

=0.007; day 7: 75.2%

vs

. 60.8%

P

=0.001). Ct values significantly increase on day 2 [ORF1ab gene: 35.62 (IQR: 29.17–45.00)

vs

. 34.22 (IQR: 28.41–39.41)

P

=0.03; N gene: 34.97 (IQR: 28.50–45.00)

vs

. 33.51 (IQR: 27.70–38.25)

P

=0.024] and day 3 [ORF1ab gene: 38.00 (IQR: 32.72–45.00)

vs

. 35.81 (IQR: 29.96–45.00)

P

=0.003; N gene: 37.16 (IQR: 32.01–45.00)

vs

. 35.26 (IQR: 29.09–45.00)

P

=0.01]. No significant difference was found in hospital length of stay between the two groups (

P

>

0.05). Symptoms of cough were significantly improved (82.2%

vs

. 70.0%

P

=0.02) and wheezing was significantly reduced (0.7%

vs

. 12.9%

P

<

0.01) in the intervention group compared with the control group. During the trial

no disease progression or serious adverse events were reported.

Conclusion:

2

Adding RYN to standard care may be a safe and effective treatment for children with asymptomatic and mild SARS-CoV-2 infection. (Registration No. ChiCTR2200060292)