Nebulized peginterferon α-2b for hand, foot, and mouth disease

Clinical Trial of Different Doses of Pegylated Interferon α-2b Injection Nebulization Therapy for Common Hand, Foot, and Mouth Disease (HFMD).

This study tests whether inhaled peginterferon α-2b given with supportive care helps children aged 1–6 with ordinary hand, foot, and mouth disease when given on days 1 and 3.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 1 Year to 6 Years
• Sex: All
• Sponsor: Zhengzhou Children's Hospital, China (Academic / other)
• Locations: 5 sites (Chengdu and 4 other locations)
• Trial ID: NCT07008755 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized trial will enroll 90 children aged 1–6 with common (ordinary) HFMD and recent symptom onset. Eligible participants are randomized to supportive care plus nebulized peginterferon α‑2b at one of two dose regimens (one arm includes 90 µg) administered on days 1 and 3, following a 3‑day screening period. The primary focus is on safety and whether the inhaled treatment improves clinical recovery during a 5–7 day inpatient observation. Outcomes will inform tolerability and potential clinical benefit of this dosing approach.

Who should consider this trial

Good fit: Children aged 1 to 6 with common HFMD who developed fever or rash within the past 72 hours and whose guardians can provide informed consent are ideal candidates.

Not a fit: Children with severe or critical HFMD, multi-organ failure, known interferon allergy, prior interferon treatment, or other listed exclusion criteria are unlikely to benefit from this inpatient nebulized therapy.

Why it matters

Potential benefit: If successful, inhaled peginterferon could shorten illness duration and reduce symptoms or complications in young children with ordinary HFMD.

How similar studies have performed: Systemic interferons have been used for other viral illnesses, but inhaled peginterferon for HFMD is largely novel and has limited published data.

Eligibility criteria

Inclusion Criteria:

-1. Age: 1 year of age ≤ Age ≤ 6 years of age. 2.Gender: Both male and female. 3.Clinical symptoms/signs: Manifesting as common type HFMD (Stage 1, rash stage), with fever or rash symptoms first occurring within 72 hours prior to the signing of the informed consent form.

4.Informed consent: Guardians understand and sign the informed consent form (if the guardian is the parent, both parents must sign).

Exclusion Criteria:

* (1) Severe or Critical HFMD Presentation at Enrollment

  1. Manifesting as severe HFMD (Stage 2, neurological involvement phase)
  2. Manifesting as critical HFMD (Stage 3 or 4, cardiopulmonary failure phase) with any of:

     Brainstem encephalitis, encephalomyelitis, or meningitis,Neurogenic pulmonary edema or respiratory failure requiring mechanical ventilation,Shock or circulatory collapse.
  3. Concurrent multi-organ failure requiring ICU monitoring

     (2) Allergy History and Treatment History

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  1. Received interferon, ribavirin, acyclovir, ganciclovir, or vidarabine monophosphate within 30 days prior to screening or current use
  2. Received immunoglobulin or glucocorticoid therapy within 30 days prior to screening or current use
  3. Known hypersensitivity to interferon or its components, or other clinically significant allergies contraindicating participation
  4. Use of other investigational drugs within 3 months or 5 half-lives (whichever is longer) prior to screening, or current participation in medical device trials

     (3) Medical History

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  1. Congenital heart disease, severe malnutrition, immune dysfunction, asthma, or other severe systemic diseases
  2. Active HBV, HCV, HIV, or Treponema pallidum infection
  3. History of malignant tumors (current or prior)
  4. History of epilepsy, neurological/psychiatric disorders, or relevant family history

     (4) Clinical Parameters: Resting respiratory rate \>40 breaths/min,Heart rate \>160 bpm

     (5) Other Considerations: Any condition deemed by investigators to render participation medically inadvisable

Where this trial is running

Chengdu and 4 other locations

• Xindu District People's Hospital of Chengdu — Chengdu, China (Recruiting)
• The Seventh People's Hospital of Liangshan Yi Autonomous Prefecture — Liangshan, China (Recruiting)
• Henan Children's Hospital (Zhengzhou Children's Hospital) — Zhengzhou, China (Recruiting)
• Zhengzhou People's Hospital — Zhengzhou, China (Recruiting)
• Ziyang Central Hospital — Ziyang, China (Recruiting)

Study contacts

• Principal investigator: Fang Wang — Zhengzhou Children's Hospital, China
• Study coordinator: Fang Wang

Conditions HFMD; Peginterferon α-2b injection