Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05501288 |
| Other study ID # |
SCMCIRB-K2022046-1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2022 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
Shanghai Children's Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The investigators conducted a single-center, open-label, parallel-group randomized controlled
trial to assess the efficacy and safety of a Chinese herb compound granule Huashi Baidu
granule (HSBDG) in pediatric patients with laboratory-confirmed mild COVID-19. 108 recruited
children (aged 3 to 18 years) with laboratory-confirmed mild COVID-19 were randomly allocated
2:1 to receive oral HSBDG for 5 consecutive days (intervention group) and to receive compound
pholcodine oral solution for 5 consecutive days (control group). The negative conversion time
of SARS-CoV-2 nucleic acid and symptom scores were recorded.
Description:
This was a single-center, open-label, parallel-group randomized controlled clinical trial,
with an allocation ratio of 2:1. Written consent was obtained from the parents of all
participants. The study was conducted in accordance with the Declaration of Helsinki and the
current Good Clinical Practice. The protocol was approved by the Institutional Ethics
Committee of Shanghai Children's Medical Center (SCMCIRB-K2022046-1) Participants and setting
Children who attended the COVID-19 Fangcang Shelter Hospitals in Shanghai, China, with
laboratory-confirmed mild COVID-19 were screened for eligibility. The inclusion criteria were
as follows: 1) compliance with the diagnostic criteria for mild COVID-19; 2) age 3 to 18
years. Participants who had underlying disease(s) such as chronic pulmonary disease,
immunodeficiency, tumors, etc., allergy or intolerance to taking Chinese medicine herbs or
compound pholcodine oral solution, or poor compliance (defined as inability to comply with
the protocol) were excluded.
Sample size Two-sample T-tests allowing unequal variance were used for sample size
calculation by Power Analysis and Sample Size Software 2021 (NCSS, LLC. Kaysville, Utah,
USA). Group sample sizes of 64 and 32 achieve 85.0% power to reject the null hypothesis of
equal means when the population mean difference is μ1 - μ2 = 10 - 11 = -1 with standard
deviations of 1.42 for the intervention group and 1.56 for the control group, and with a
significance level (alpha) of 0.05 using a two-sided two-sample unequal-variance t-test. The
aim was to recruit 108 participants to allow for a 12% attrition rate.
Randomization and Blinding Patients were randomly assigned 2:1 to the intervention group or
the control group by a researcher who was not otherwise involved in the study using random
sequences generated by SPSS software 25.0 (IBM SPSS Statistics, Armonk, NY, USA). This was an
open-label trial. Patients, investigators, and statisticians were not masked to the group
assignment.
Intervention In the intervention group, patients were given HSBDG the day after
randomization, with a dose of 2.5g for age 3 to 6 years, 5 g for age 7 to 12 years, and 10 g
for age 13 to 18 years, twice daily for 5 consecutive days. In the control group, patients
were given compound pholcodine oral solution (Bright Future Pharmaceuticals Factory, Hong
Kong, CHN) the day after randomization, with a dose of 5 ml for age 3 to 6 years and 10 ml
for age 7 to 18 years, three times daily for 5 consecutive days. The day of randomization was
set as day 0. By free Instant messaging software (WeChat; Tencent, Shenzhen, CHN) available
on smart phones, parents received questionnaires (Table S1 for symptom scores at days 0, 3
and 5) and be asked to complete them truthfully. For each patient, one SARS-CoV-2 nucleic
acid real-time PCR test for the specimen from the upper respiratory tract was performed
daily. Patients would be not considered to be discharged until two consecutive negative
reports were confirmed.
Primary outcome The primary outcome of the study was the time for SARS-CoV-2 nucleic acid
negative conversion after randomization. The time from day 0 to the day of two consecutive
negative reports confirmed was defined as the negative conversion time.
Secondary outcomes The secondary outcomes for the study were symptom improvements at days 3
and 5, and antibiotic use and side effects from day 1 to discharge. Total symptom score was
the sum of the scores of primary symptoms (fever, cough, expectoration, sore throat,
wheezing, and chest pain) and secondary symptoms (dry stool, dark urine or oliguria, poor
appetite, low energy, tired, nausea or vomiting, and diarrhea).
Statistical analysis Data were presented as frequencies and percentages for categorical
variables and as medians and interquartile range (IQR) for continuous variables. Categorical
variables were compared by the chi-square test. Continuous variable comparisons were
performed by the Mann-Whitney U test. P-value < 0.05 was considered to be statistical
significance. All analyses were performed using SPSS software 25.0 (IBM SPSS Statistics,
Armonk, NY, USA).
