Study of Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI)

PHASE4CompletedINTERVENTIONAL
Enrollment

338

Participants

Timeline

Start Date

August 4, 2021

Primary Completion Date

November 4, 2021

Study Completion Date

November 4, 2021

Conditions
Recurrent Respiratory Tract Infections
Interventions
DRUG

Pidotimod

Participants will be randomized in ratio of 1:1 to receive Pidotimod 400 milligrams (mg), once daily (no infection present) or twice daily (infection present) orally up to Day 60 during the double-blind treatment period.

DRUG

Placebo

Participants will be randomized in ratio of 1:1 to receive placebo matched to Pidotimod, once daily (no infection present) or twice daily (infection present) orally up to Day 60 during the double-blind treatment period.

Trial Locations (16)

100020

Investigator Site 01 Children's Hospital Captial Institute of Pediatrics, Beijing

Unknown

Investigator Site 16, Changchun

Investigator Site 09, Changde

Investigator Site 12, Changsha

Investigator Site 07, Guangzhou

Investigator Site 10, Guilin

Investigator Site 14, Kunming

Investigator Site 03, Nanjing

Investigator Site 11, Sanya

Investigator Site 02, Shanghai

Investigator Site 06, Shantou

Investigator Site 13, Shaoyang

Investigator Site 05, Tianjin

Investigator Site 04, Xiamen

Investigator Site 08, Yanji

Investigator Site 15, Zhengzhou

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Almirall, S.A.

INDUSTRY

NCT04322669 - Study of Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI) | Biotech Hunter | Biotech Hunter