This is a multicenter clinical trial investigating the safety and efficacy of inhaled Peginterferon α-2b at different doses, in combination with supportive care, for the treatment of patients with hand, foot, and mouth disease (HFMD) of ordinary type. The trial aims to enroll 90 patients with HFMD. Eligible subjects will be randomly assigned to receive either supportive care + Peginterferon α-2b mcg or supportive care + Peginterferon α-2b 90 mcg, administered on days 1 and 3. The study period includes a 3-day screening phase and a 5-7 day inpatient visit period. The results of this trial will be used to evaluate safety and efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
During the study period, patients will continue to receive symptomatic supportive therapy, along with nebulized Peginterferon α-2b injection at a dose of 45 μg per administration, to be delivered on Day 1 and Day 3.
CoDuring the study period, patients will continue to receive symptomatic supportive therapy, along with nebulized Peginterferon α-2b injection at a dose of 90 μg per administration, to be delivered on Day 1 and Day 3.
Xindu District People's Hospital of Chengdu
Chengdu, China
RECRUITINGThe Seventh People's Hospital of Liangshan Yi Autonomous Prefecture
Liangshan, China
RECRUITINGHenan Children's Hospital (Zhengzhou Children's Hospital)
Zhengzhou, China
RECRUITINGZhengzhou People's Hospital
Zhengzhou, China
RECRUITINGZiyang Central Hospital
Ziyang, China
RECRUITINGMedian time to resolution of fever
Time frame: Day5-7.
Median time to resolution of skin rash
Time frame: Day5-7.
Median time to resolution of oral ulcers
Time frame: Day5-7.
Median time to resolution of feeding difficulties
Time frame: Day5-7.
Proportion of patients with complete recovery of fever
Time frame: Day 3
Proportion of patients with complete recovery of fever
Time frame: Day 5
Proportion of patients with complete recovery of rash
Time frame: Day 3
Proportion of patients with complete recovery of rash
Time frame: Day 5
Proportion of patients with complete recovery of oral ulcers
Time frame: Day 3
Proportion of patients with complete recovery of oral ulcers
Time frame: Day 5
Proportion of patients with complete recovery of feeding difficulties
Time frame: Day 3
Proportion of patients with complete recovery of feeding difficulties
Time frame: Day 5
Proportion of patients showing improvement in fever
Time frame: Day 3
Proportion of patients showing improvement in fever
Time frame: Day 5
Proportion of patients showing improvement in rash
Time frame: Day 3
Proportion of patients showing improvement in rash
Time frame: Day 5
Proportion of patients showing improvement in oral ulcers
Time frame: Day 3
Proportion of patients showing improvement in oral ulcers
Time frame: Day 5
Proportion of patients showing improvement in feeding difficulties
Time frame: Day 3
Proportion of patients showing improvement in feeding difficulties
Time frame: Day 5
Proportion of patients developing pulmonary edema
Time frame: Day1-7
Proportion of patients developing myocarditis
Time frame: Day1-7
Proportion of patients developing respiratory failure
Time frame: Day1-7
Proportion of patients developing circulatory failure
Time frame: Day1-7
Proportion of patients developing meningoencephalitis
Time frame: Day1-7
Proportion of patients achieving viral nucleic acid negativity
Time frame: Day 3
Proportion of patients achieving viral nucleic acid negativity
Time frame: Day 5
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