Qingfei Paidu Granules for SARS-CoV-2 Omicron variant infection in children: A randomized controlled trial

To evaluate the short-term efficacy and safety of Qingfei Paidu (QFPD) Granules as an alternative therapeutic option for children infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Fifty-two children with SARS-CoV-2 Omicron variant infection were randomly divided into a treatment group ( n = 26) treated with QFPD Granules and a control group ( n = 26) treated with ibuprofen at Shanghai Children’s Medical Center from May 15 to June 8, 2022. In the trial, the short-term efficacy and safety were investigated and evaluated by assessing symptoms, the duration of symptom recovery, and liver or renal function after treatment. Forty-four children (QFPD Granules group, n = 21; control group, n = 23) completed the trial out of the 52 participants initially enrolled. Compared with the control group, the QFPD Granules group exhibited significantly shorter fever duration ( P = 0.003 1) and inpatient duration ( P = 0.005 3); however, no statistically significant differences were observed in peak fever duration or the duration of SARS-CoV-2 positivity between mild and severe cases. Additionally, no significant differences were observed in the improvement of other clinical symptoms, such as cough duration, sore throat, myalgia, malaise, or poor appetite, between the two groups. Both groups experienced comparable rates of clinical complications and side effects, including nausea or vomiting, diarrhea, stomach or abdominal pain, and skin itching or erythema. Laboratory analyses revealed no significant changes in white blood cell (WBC) count, C-reactive protein (CRP) levels returning to normal ranges, or evidence of liver damage as indicated by alanine transaminase (ALT) and aspartate transaminase (AST) levels. Furthermore, no significant renal damage was observed based on blood urea nitrogen (BUN) and creatinine levels. The QFPD Granules are safe and effective in improving symptoms, reducing the duration of symptom recovery, and shortening the presence of viral nucleic acid in children infected with the Omicron BA.2 variant of SARS-CoV-2.