Influenza and Acute Respiratory Viral InfectionsPhase 4NCT02072174
Efficacy of Anaferon for Children in the Treatment of Influenza and Acute Respiratory Viral Infections in Children
A Phase 4 study testing Anaferon for Children in people with Influenza and Acute Respiratory Viral Infections, run by Materia Medica Holding at 27 sites in 3 countries.
Trial summary
The purpose of this study is: To obtain additional data on therapeutic efficacy of Anaferon for children in the treatment of influenza and acute respiratory viral infections in children Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Influenza and Acute Respiratory Viral Infections
- What is being tested?
- Anaferon for Children
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 569 participants
- Where
- 27 sitesin 3 countries
- Study dates
- 8 Oct 2014to 16 Apr 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients of both sexes aged 3-12 years inclusively.
- Diagnosis of influenza/ARVI according to physician's examination: body temperature ≥ 38.0°C at the time of examination + symptom score ≥ 4 (at least 1 systemic symptom ≥2 and 1 nasal/throat/chest symptom ≥2 or several symptoms ≥ 1 score).
- The first 24 hours from the beginning of manifestations of influenza/ARVI.
- The possibility to start therapy within 24 hours from the first symptoms of ARVI.
- Availability of a patient information sheet (Informed Consent form) for parents/adoptive parents for participation in the study signed by one of the parents/adoptive parents.
Who cannot join
- Suspected pneumonia, bacterial infection or severe disease requiring antibacterial products (including sulfanilamides) starting from the first day of the disease.
- Clinical symptoms of severe influenza/ARVI requiring hospitalization.
- Suspected initial manifestations of the diseases having the symptoms similar to the ones of influenza/ARVI (other infectious diseases, influenza-like syndrome at debut of systemic connective tissue diseases, oncohematological and other diseases).
- Medical history of primary and secondary immunodeficiencies: а) lymphoid system immunodeficiencies (Т-cell and/or B-cell, immunodeficiencies with predominant antibody deficiency); b) phagocytic deficiencies; c) complement factor deficiency; d) combined immunodeficiencies including AIDS secondary to HIV-infection; toxic, autoimmune, infectious, radiation panleukopenic syndrome; systemic lymphocytopenic syndrome; polyclonal lymphocytic activation syndrome; postsplenectomic syndrome; congenital asplenia; immune complex pathological syndrome associated with infectious, autoimmune and allergic diseases.
- Medical history of sarcoidosis.
- Oncology.
Show all 17Show fewer
- Exacerbation or decompensation of chronic diseases affecting ability to participate in the clinical study.
- Medical history of polyvalent allergy.
- Allergy/intolerance to any of the components of medications used in the treatment.
- Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
- Intake of medicines listed in the section "Prohibited concomitant therapy" within 1 month prior to the inclusion in the study.
- Drug addiction, alcohol consumption at more than 2 alcohol units per day by the subject's parents/adoptive parents.
- Mental diseases of the subject, parents/adoptive parents.
- Subjects whose parents/adoptive parents, according to the investigator's point of view, will not follow the observation requirements during the study or study product dosing regimen.
- Participation in other clinical studies within 3 months prior to the inclusion in the study.
- Parent/adoptive parent of the subject is related to the investigator team of medical facility directly involved in the study or is a close relative of the investigator. Close relatives include spouse, parents, children or brothers (sisters) regardless of whether they are biological or adoptive ones.
- Parent/adoptive parent of the subject is working in OOO "NPF "Materia Medica Holding", i.e. is the company official, temporary contract worker or an appointed official responsible for the study or their close relatives.
Trial locations and contacts
27 sites in 3 countries.
27 sites in 3 countries
Russia22 sites
Clinic of State Budgetary Institution "Research Institute of nutrition" of the Russian Academy of Medical Sciences
Moscow, 109240
Russian National Research Medical University named after N.I. Pirogov
Moscow, 117997
Russian National Research Medical University
Moscow, 117997
Russian National Research Pirogov Medical University
Moscow, 117997
State Educational Institution of Higher Professional Education "Moscow State Medical Academy named after I.M. Sechenov"
Moscow, 119991
State Budgetary Institution of Health, "Children's City Hospital № 9 named after G.N. Speranskii"
Moscow, 123317
State Budgetary Educational Institution of Additional Professional Education "Russian Russian Medical Academy of Postgraduate Education" of Ministry of Health of Russian Federation
Moscow, 123995
State Budgetary Educational Institution of Higher Professional Education " Nizhny Novgorod State Medical Academy" of Ministry of Health of Russian Federation
Nizhny Novgorod, 603005
State Budgetary Educational Institution of Higher Professional Education ''Novosibirsk State Medical University'' of Ministry of Health of Russian Federation
Novosibirsk, 630091
Municipal Health Care Institution "City Child Health Clinical Polyclinic №5"
Perm, 614066
State Budgetary Educational Institution of Higher Professional Education "Rostov State Medical University"
Rostov-on-Don, 344022
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44"
Saint Petersburg, 192212
St. Petersburg State health institution " City Child Health Polyclinic № 45"
Saint Petersburg, 193312
State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Pediatric Medical Academy" of Ministry of Health of Russian Federation
Saint Petersburg, 194100
Limited Liability Company "Alliance Biomedical-Russian group"
Saint Petersburg, 194356
Co.Ltd "Clinic Allergomed"
Saint Petersburg, 196084
State Health Care Institution "Child Health City Hospital №22"
Saint Petersburg, 196650
Bashkir State Medical University of Ministry of Health of Russian Federation
Ufa, 450000
State Budgetary Educational Institution of Higher Professional Education " Yaroslavl State Medical Academy" of Ministry of Health of Russian Federation
Yaroslavl, 150000
State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy"
Yaroslavl, 150000
State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy
Yaroslavl, 150000
Yaroslavl State Medical Academy
Yaroslavl, 150000
Belarus3 sites
City Child Health Clinical Polyclinic №13
Minsk, 220024
Municipal Health Care Institution "City Child Health Clinical Polyclinic №10"
Minsk, 220118
City Child Health Clinical Polyclinic №17
Minsk, 220131
Ukraine2 sites
Vinnytsya M.I. Pyrogov National Medical University
Vinnytsia, 21018
Public institution "Zaporizhzhya city multidisciplinary children's hospital №5"
Zaporozh’ye, 69076
About this study
Official title: International Multicenter Double-blind Placebo-controlled Randomized Parallel Group Clinical Trial of Efficacy of Anaferon for Children in the Treatment of Influenza and Acute Respiratory Viral Infections in Children
The purpose of this study is:
- To obtain additional data on therapeutic efficacy of Anaferon for children in the treatment of influenza and acute respiratory viral infections in children
Read the detailed description
The study will enroll outpatient subjects of both sexes aged 3-12 years with clinical manifestations of influenza/Acute Respiratory Viral Infections (ARVI), including fever
≥ 38.0°С having an appointment with a doctor within the first day after the illness onset.
Тhe physician will collect medical history information, perform an objective examination, record the concomitant therapy, and obtain nasal swab specimens for a rapid diagnostic influenza test. If the swab is positive, the doctor shall obtain swab specimens from the nasal cavity and oropharynx (nasopharyngeal swab) for a subsequent real time reverse transcription-polymerase chain reaction (RT-PCR) to determine the viral load of influenza A and/or B virus. If the swab is negative for influenza the doctor shall collect a nasopharyngeal swab for a subsequent PCR test for other respiratory viruses.
If inclusion criteria are met and exclusion criteria are absent at visit 1 (Day 1), the patient will be enrolled in the trial and randomized into one of the two groups: group 1 patients will take Anaferon for children following a 5-day regimen; group 2 patients will receive Placebo using the Anaferon for children 5-day regimen. The parent/adopter of patient will receive a diary where they should record the child's axillary temperature data in the morning and evening, and score the severity of symptoms.
The subject will be monitored for 14 days (screening, randomization - 1 day, treatment - 5 days, follow-up - 1 day; late-scheduled phone "visit" - day 14).
At Visits 2-4, the physician will document objective examination data; obtain nasopharyngeal swabs from subjects with positive influenza tests for subsequent RT-PCR to determine the viral load and its reduction in the course of treatment; monitor the prescribed and concomitant therapy, and check the patient's diary data. The phone "visit" will be made to elicit information from the parents regarding the patient's general health, presence/absence of secondary bacterial/viral complications, and use of antibacterial drugs.
Interim statistical analysis is stipulated by the study protocol. Interim analysis will be performed using the data obtained from the examination and treatment of the protocol-defined number of patients who completed the study. Based on the expected effect, the minimum required Particular Per Protocol (pPP) sample size will be 254 patients (127 subjects in each group - Anaferon for children and Placebo).
- Being tested
- Anaferon for Children
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anaferon for ChildrenDrug
Also called Anaferon for Children in tablets
Anaferon for children: For oral use.
| Study group | Role | What they receive |
|---|---|---|
| Anaferon for Children | Experimental | On day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day. From day 2 through 5, one tablet is administered three times daily. Receives: Drug: Anaferon for Children |
| Placebo | Placebo comparator | On day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day. From day 2 through 5, one tablet is administered three times daily. Receives: Drug: Anaferon for Children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Illness Duration
Disease duration is assessed until recovery or significant improvement. Average illness duration is defined as the interval between the start of the trial treatment and the start of the first 24-hour period in which the non-specific symptoms and nasal/ throat/ chest symptoms improve to "absent" or "mild" (Total Symptom Score of severity had decreased to ≤2 points) and body temperature returns to 37.2°C or below.
Based on patient diary data.
Measured: From the time of randomization until the time of recovery/improvement (days 1-14)
Secondary outcomes (8)
Percentage of Patients With Recovery/Improvement in Health
Based on Days 2, 3, 4 and 5 of observation treatment (according to the patient's diary), on days 3 and 5 of therapy (according to physician's objective examination).
Measured: on days 2, 3, 4 and 5 of the treatment
Changes in Body Temperature
Changes in Body Temperature Based on Patient Diary Data
Measured: baseline and days 2, 3, 4 and 5 of observation treatment
Percentage of Patients With Normal Body Temperature (≤37.0ºС)
Based on the patient diary data. Axillary temperature (morning and evening) decline to or below 37.0 ºС.
Measured: on days 2, 3, 4 and 5 of observation treatment
Severity of Clinical Manifestations of Influenza / Acute Respiratory Viral Infection by Total Symptom Score.
Total Symptom Score is based on the severity of each Influenza / Acute Respiratory Viral Infection symptom.
Total Symptom Score includes 13 symptoms: body temperature, non-specific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), nasal/throat/chest symptoms.
The severity of non-specific and nasal/throat/chest symptom is scored on a symptom severity scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms).
Minimum score=0; maximum score=39. The severity of symptoms is recorded by the doctors on the case record form on days 3, 5 and by parents/adopter on a diary card twice a day on days 2-6.
Measured: on days 2-6 of observation treatment
Assessment of the Severity of Influenza Virus / Acute Respiratory Viral Infection Using the "Area Under the Curve" for an Overall Symptom Assessment
Total Symptom Score is based on the severity of each disease symptom. The TSS includes 13 symptoms: body temperature/fever, non-specific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, sore throat, hoarseness, cough, chest pain/tightness of the chest).
Minimum score=0; maximum score=39. The area under the curve 1 = on days 1, 3, 5 and 7 on the results of doctor's examination The area under the curve 2 = based on days 1-7 on the patient diary data
Measured: on days 1-7 of observation (based on days 1-7 on the patient diary data; on days 1, 3, 5 and 7 of observation - according to physician's objective examination)
Number of Intakes of Antipyretics
Number of Intakes of Antipyretics based on patient diary data
Measured: on days 1-5 of therapy
Change in Viral Load During the Treatment and Follow-up Periods
Viral load is evaluated in subjects with positive influenza A and B tests. Virus load [log10 copies influenza А/В RNA per 1 mL] in nasal and pharyngeal swabs is determined using real-time PCR on days 1, 3, 5 and 7.
Measured: on days 1, 3, 5, 7 of observation treatment
Percentage of Patients With Exacerbation of the Disease Course
The development of disease complications requiring antibiotics drugs or hospitalization
Measured: 14 days of observation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study start8 Oct 2014
- Primary completion16 Apr 2018
- Study completion16 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Influenza and Acute Respiratory Viral InfectionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 569 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elena Andrianova, Professor, Study director, Materia Medica Holding
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072174
- Sponsor's protocol ID
- MMH-AD-004
- Status last verified
- Jul 2019
- First submitted
- 14 Feb 2014
- Last updated
- 12 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicenter Double-blind Placebo-controlled Randomized Parallel Group Clinical Trial of Efficacy of Anaferon for Children in the Treatment of Influenza and Acute Respiratory Viral Infections in Children
- ClinicalTrials.gov ID
- NCT02072174
- Acronym / sponsor ID
- MMH-AD-004
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 569 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2014 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 16 Apr 2018 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Posted 12 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is:
- To obtain additional data on therapeutic efficacy of Anaferon for children in the treatment of influenza and acute respiratory viral infections in children
Detailed description
The study will enroll outpatient subjects of both sexes aged 3-12 years with clinical manifestations of influenza/Acute Respiratory Viral Infections (ARVI), including fever
≥ 38.0°С having an appointment with a doctor within the first day after the illness onset.
Тhe physician will collect medical history information, perform an objective examination, record the concomitant therapy, and obtain nasal swab specimens for a rapid diagnostic influenza test. If the swab is positive, the doctor shall obtain swab specimens from the nasal cavity and oropharynx (nasopharyngeal swab) for a subsequent real time reverse transcription-polymerase chain reaction (RT-PCR) to determine the viral load of influenza A and/or B virus. If the swab is negative for influenza the doctor shall collect a nasopharyngeal swab for a subsequent PCR test for other respiratory viruses.
If inclusion criteria are met and exclusion criteria are absent at visit 1 (Day 1), the patient will be enrolled in the trial and randomized into one of the two groups: group 1 patients will take Anaferon for children following a 5-day regimen; group 2 patients will receive Placebo using the Anaferon for children 5-day regimen. The parent/adopter of patient will receive a diary where they should record the child's axillary temperature data in the morning and evening, and score the severity of symptoms.
The subject will be monitored for 14 days (screening, randomization - 1 day, treatment - 5 days, follow-up - 1 day; late-scheduled phone "visit" - day 14).
At Visits 2-4, the physician will document objective examination data; obtain nasopharyngeal swabs from subjects with positive influenza tests for subsequent RT-PCR to determine the viral load and its reduction in the course of treatment; monitor the prescribed and concomitant therapy, and check the patient's diary data. The phone "visit" will be made to elicit information from the parents regarding the patient's general health, presence/absence of secondary bacterial/viral complications, and use of antibacterial drugs.
Interim statistical analysis is stipulated by the study protocol. Interim analysis will be performed using the data obtained from the examination and treatment of the protocol-defined number of patients who completed the study. Based on the expected effect, the minimum required Particular Per Protocol (pPP) sample size will be 254 patients (127 subjects in each group - Anaferon for children and Placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anaferon for Children | Experimental | Drug: Anaferon for ChildrenOn day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day. From day 2 through 5, one tablet is administered three times daily. |
| Placebo | Placebo comparator | Drug: Anaferon for ChildrenOn day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day. From day 2 through 5, one tablet is administered three times daily. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients of both sexes aged 3-12 years inclusively.
- Diagnosis of influenza/ARVI according to physician's examination: body temperature ≥ 38.0°C at the time of examination + symptom score ≥ 4 (at least 1 systemic symptom ≥2 and 1 nasal/throat/chest symptom ≥2 or several symptoms ≥ 1 score).
- The first 24 hours from the beginning of manifestations of influenza/ARVI.
- The possibility to start therapy within 24 hours from the first symptoms of ARVI.
- Availability of a patient information sheet (Informed Consent form) for parents/adoptive parents for participation in the study signed by one of the parents/adoptive parents.
Key exclusion criteria (17 listed)
- Suspected pneumonia, bacterial infection or severe disease requiring antibacterial products (including sulfanilamides) starting from the first day of the disease.
- Clinical symptoms of severe influenza/ARVI requiring hospitalization.
- Suspected initial manifestations of the diseases having the symptoms similar to the ones of influenza/ARVI (other infectious diseases, influenza-like syndrome at debut of systemic connective tissue diseases, oncohematological and other diseases).
- Medical history of primary and secondary immunodeficiencies: а) lymphoid system immunodeficiencies (Т-cell and/or B-cell, immunodeficiencies with predominant antibody deficiency); b) phagocytic deficiencies; c) complement factor deficiency; d) combined immunodeficiencies including AIDS secondary to HIV-infection; toxic, autoimmune, infectious, radiation panleukopenic syndrome; systemic lymphocytopenic syndrome; polyclonal lymphocytic activation syndrome; postsplenectomic syndrome; congenital asplenia; immune complex pathological syndrome associated with infectious, autoimmune and allergic diseases.
- Medical history of sarcoidosis.
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 |
|---|---|---|
| Anaferon for ChildrenAlso: Anaferon for Children in tabletsAnaferon for children: For oral use. | Drug | Anaferon for Children, Placebo |
Primary outcome
Average Illness Duration
Time frame: From the time of randomization until the time of recovery/improvement (days 1-14)
Disease duration is assessed until recovery or significant improvement. Average illness duration is defined as the interval between the start of the trial treatment and the start of the first 24-hour period in which the non-specific symptoms and nasal/ throat/ chest symptoms improve to "absent" or "mild" (Total Symptom Score of severity had decreased to ≤2 points) and body temperature returns to 37.2°C or below. Based on patient diary data.
8 secondary outcomes
Percentage of Patients With Recovery/Improvement in Health
Time frame: on days 2, 3, 4 and 5 of the treatment
Changes in Body Temperature
Time frame: baseline and days 2, 3, 4 and 5 of observation treatment
Percentage of Patients With Normal Body Temperature (≤37.0ºС)
Time frame: on days 2, 3, 4 and 5 of observation treatment
Severity of Clinical Manifestations of Influenza / Acute Respiratory Viral Infection by Total Symptom Score.
Time frame: on days 2-6 of observation treatment
Assessment of the Severity of Influenza Virus / Acute Respiratory Viral Infection Using the "Area Under the Curve" for an Overall Symptom Assessment
Time frame: on days 1-7 of observation (based on days 1-7 on the patient diary data; on days 1, 3, 5 and 7 of observation - according to physician's objective examination)
Number of Intakes of Antipyretics
Time frame: on days 1-5 of therapy
Change in Viral Load During the Treatment and Follow-up Periods
Time frame: on days 1, 3, 5, 7 of observation treatment
Percentage of Patients With Exacerbation of the Disease Course
Time frame: 14 days of observation treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Elena Andrianova, Professor study director
Materia Medica Holding
27 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anaferon for Children in people with Influenza and Acute Respiratory Viral Infections, run by Materia Medica Holding at 27 sites in 3 countries.
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 5 inclusion and 17 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: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Russia, Belarus, Ukraine. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Illness Duration (time frame: From the time of randomization until the time of recovery/improvement (days 1-14)). 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 12 Jul 2019.