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Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Children 7-12 y.o.

NCT03191097 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2017-06-19

No results posted yet for this study

Summary

The purpose of this study is to determine whether Ingavirin ® dosed 60 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in 7-12 years old patients.

Conditions

Interventions

DRUG

Ingavirin

Ingavirin capsules 60 mg once daily, regardless of meal, for 5 days.

DRUG

Placebo oral capsule

Placebo, capsules daily for 5 days.

Sponsors & Collaborators

  • Atlant Clinical Ltd.

    collaborator OTHER

  • Valenta Pharm JSC

    lead INDUSTRY

Principal Investigators

  • Ekaterina Zakharova, MD, PhD · Valenta Pharm JSC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2014-12-31
Completion
2015-03-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03191097 on ClinicalTrials.gov