Respiratory Infections in ChildrenPhase 3NCT04149431
Multicenter Study to Evaluate Efficacy, Tolerability, Safety of Derinat
A Phase 3 study testing Derinat in people with Respiratory Infections in Children, run by PharmPak, LLC at 1 site in Russia.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Respiratory Infections in Children
- What is being tested?
- Derinat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteRussia
- Study dates
- 15 Dec 2019to 31 May 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed informed consent
- Male and female patients.
- 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.
- 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).
- The positive result of the enzyme immunoassay express test for pathogens of acute respiratory infection of the upper respiratory tract on screening.
- At least one episode of body temperature up to 38C and above within 48 hours prior to screening.
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- Presence of at least one of the following mild to moderate symptoms at screening: headache, weakness/malaise, muscle pain/aching, feeling of heat/chills.
- The duration of the disease is not more than 48 hours at the time of screening according to the patient/parents/adoptive parents.
- Adequate contraceptive methods during the study for the patients with childbearing potential
Who cannot join
- Positive express test (in urine) for pregnancy in patients with childbearing potential (menarche).
- Individual intolerance or hypersensitivity to any of the components of the drug according to the medical history.
- Taking any drugs with immunomodulatory effect less than 30 days before screening according to medical history.
- 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).
- 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.
- Chronic diseases of the respiratory system (Bronchial asthma, COPD).
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- HIV infection, chronic viral hepatitis B or C (according to history).
- Impaired renal function with serum creatinine level more than 1.5 times higher than the upper limit of the normal range.
- 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.
- Participation in any clinical trials and / or taking an experimental drug within 30 days prior to the screening visit.
- Other significant diseases and conditions of the patient, including mental and physical diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Respiratory Infections in Children
- Being tested
- Derinat
- Keywords
- Derinat, Respiratory infection, Children
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DerinatDrug
Also called desoxyribonucleate sodium
desoxyribonucleate sodium
| Study group | Role | What they receive |
|---|---|---|
| Derinat | Active comparator | nasal drops Receives: Drug: Derinat |
| Placebo | Placebo comparator | nasal drops Receives: Drug: Derinat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 30 days
Secondary outcomes (2)
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
Measured: 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
Measured: through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start15 Dec 2019 (estimated)
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Infections in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PharmPak, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Irina Gerasimova, Dr., Study director, PharmPak, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149431
- Sponsor's protocol ID
- ДК-18
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04149431
- Acronym / sponsor ID
- ДК-18
- Conditions
- Respiratory Infections in Children
- Keywords
- Derinat, Respiratory infection, Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- PharmPak, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2019 (estimated)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| Derinat | Active comparator | Drug: Derinatnasal drops |
| Placebo | Placebo comparator | Drug: Derinatnasal drops |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Signed informed consent
- Male and female patients.
- 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.
- 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).
- The positive result of the enzyme immunoassay express test for pathogens of acute respiratory infection of the upper respiratory tract on screening.
Key exclusion criteria (11 listed)
- Positive express test (in urine) for pregnancy in patients with childbearing potential (menarche).
- Individual intolerance or hypersensitivity to any of the components of the drug according to the medical history.
- Taking any drugs with immunomodulatory effect less than 30 days before screening according to medical history.
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DerinatAlso: desoxyribonucleate sodiumdesoxyribonucleate sodium | Drug | Derinat, Placebo |
Primary outcome
Superiority of Derinat
Time frame: through study completion, an average of 30 days
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
2 secondary outcomes
Efficacy of Derinat
Time frame: through study completion, an average of 30 days
Safety of Derinat
Time frame: through study completion, an average of 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irina Gerasimova, Dr. study director
PharmPak, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Derinat in people with Respiratory Infections in Children, run by PharmPak, LLC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irina Gerasimova, Dr. (+79168008485, gerasimova@derinat.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superiority of Derinat (time frame: through study completion, an average of 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.