Multicenter Study to Evaluate Efficacy, Tolerability, Safety of Derinat

Multicenter Double Blinded Placebo-controlled Randomized Study to Evaluate Clinical Efficacy, Tolerability, Safety of Medical Product Derinat®, Solution for External and Local Use 0.25% in Acute Infections of Respiratory System in Children

This multicenter prospective double blinded placebo-controlled randomized study is designed to to evaluate clinical efficacy, tolerability and safety of medical product Derinat®, solution for external and local use 0.25% in acute infections of respiratory system in children

Study Overview

• Status: Unknown
• Conditions: Respiratory Infections in Children
• Intervention / Treatment: Drug: Derinat

Detailed Description

This is a multi-center, double-blind, randomized phase III-IV clinical trial in parallel groups to evaluate the efficacy and safety of Derinat versus Placebo in patients with acute upper respiratory tract infection.

The study will include only patients with mild to moderate acute upper respiratory tract infection, without complications. According to the recommendations of the FDA (Guidance for Industry Influenza: Developing Drugs for Treatment and/or Prophylaxis) this category of patients is the best suited for placebo-controlled studies, because the expected serious risks without treatment are negligible. For studies evaluating the therapy of patients with mild to moderate acute respiratory upper respiratory tract infection without complications, a placebo-controlled trial design is preferred, as opposed to designs with no less efficacy (non-inferiority).

This study provides for the inclusion of both outpatient patients and patients admitted to the hospital for epidemiological indications (i.e. patients with acute respiratory infection of the upper respiratory tract of mild and moderate severity without complications that pose an epidemic risk.

Assessment of criteria of severity of acute respiratory infection of the upper respiratory tract will be carried out by Investigator based on standards of diagnosis and treatment of infectious diseases in children at the stages of medical care, depending on the forms of severity of the disease.

The study is planned sequentially in 5 age groups. The study begins with the older age group and as the results on the safety of the drug are obtained, in the course of the study, it is possible to move to younger age groups

• Study Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Irina Gerasimova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed informed consent
2. Male and female patients.
3. The age of the child at the time of first intranasal administration of drug for age group 1: 12 years to <18 years; for age group 2: from 6 years to <12 years; for age group 3: from 2 years to <6 years; for age group 4: 7 months to <2 years; for age group 5: from 0 months to 6 months.
4. Outpatient and inpatient patients hospitalized for epidemiological reasons, with a diagnosis of acute respiratory infection of the upper respiratory tract of mild to moderate severity. (ICD 10: J00 - J06 Acute respiratory infections of the upper respiratory tract).
5. The positive result of the enzyme immunoassay express test for pathogens of acute respiratory infection of the upper respiratory tract on screening.
6. At least one episode of body temperature up to 38C and above within 48 hours prior to screening.
7. Presence of at least one of the following mild to moderate symptoms at screening: headache, weakness/malaise, muscle pain/aching, feeling of heat/chills.
8. The duration of the disease is not more than 48 hours at the time of screening according to the patient/parents/adoptive parents.
9. Adequate contraceptive methods during the study for the patients with childbearing potential

Exclusion Criteria:

1. Positive express test (in urine) for pregnancy in patients with childbearing potential (menarche).
2. Individual intolerance or hypersensitivity to any of the components of the drug according to the medical history.
3. Taking any drugs with immunomodulatory effect less than 30 days before screening according to medical history.
4. The presence of complications of acute respiratory infection of the upper respiratory tract, signs of severe disease at the time of screening (fever more than 39ºC, febrile convulsions).
5. Acute infectious diseases: diphtheria, measles, infectious mononucleosis, herpes type 1 and 2, rubella, scarlet fever, acute BGSA-tonsillopharyngitis at the time of screening or 30 days before screening.
6. Chronic diseases of the respiratory system (Bronchial asthma, COPD).
7. HIV infection, chronic viral hepatitis B or C (according to history).
8. Impaired renal function with serum creatinine level more than 1.5 times higher than the upper limit of the normal range.
9. Severe liver failure or active liver disease (including viral hepatitis B or C) and increase of ALT and AST more than 5 times of upper limit of the normal range.
10. Participation in any clinical trials and / or taking an experimental drug within 30 days prior to the screening visit.
11. Other significant diseases and conditions of the patient, including mental and physical diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Derinat; nasal drops	Drug: Derinat; desoxyribonucleate sodium; Other Names: desoxyribonucleate sodium
Placebo Comparator: Placebo; nasal drops	Drug: Derinat; desoxyribonucleate sodium; Other Names: desoxyribonucleate sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superiority of Derinat	Assessment of frequency of resolution of symptoms of acute respiratory infection of the upper respiratory tract confirmed by the absence of symptoms (0 points on the scale of evaluation of symptoms of acute upper respiratory infection during at least 24 hours	through study completion, an average of 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Derinat	Assessment of frequency of resolution of symptoms of acute upper respiratory infection? time from start of investigational therapy to resolution of symptoms of acute upper respiratory infection and assessment of frequency of elimination of pathogens of acute respiratory infections of the upper respiratory tract from the mucous membrane of the nasopharynx and oropharynx to Day 8	through study completion, an average of 30 days
Safety of Derinat	Assessment of incidence of complications in acute upper respiratory tract infection and the incidence of adverse events and serious adverse events of varying severity according to subjective complaints, laboratory tests, physical examination, assessment of vital signs and electrocardiography	through study completion, an average of 30 days

Collaborators and Investigators

• Sponsor: PharmPak, LLC
• Investigators: Study Director: Irina Gerasimova, Dr., PharmPak, LLC

Study record dates

Study Major Dates

• Study Start (Anticipated): December 15, 2019
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Children; Derinat; Respiratory infection
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Infections; Respiratory Tract Infections
• Other Study ID Numbers: ДК-18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No