Acute Respiratory Viral Infections Clinical Trial
Official title:
Multicentre Double-blind Placebo-controlled Parallel Group Randomized Clinical Trial of Efficacy and Safety of Anaferon in the Treatment of Acute Respiratory Viral Infections
Purpose of the study:
• To obtain additional data on the efficacy and safety of Anaferon in the treatment of acute
respiratory viral infections.
Design: a multicenter, double-blind, placebo-controlled, parallel-group randomized trial.
The study will enroll patients of either gender aged 18-70 years old with clinical
manifestations of ARVI within the first day after the onset of the disease. Signed
information sheet for patient will be obtained from all participants prior to the screening
procedures. Medical history, concomitant medication, thermometry, patient examination by a
doctor, assessment of ARVI symptoms severity will be performed at screening visit.
The nasopharyngeal swabs will be performed for Real-time reverse transcription polymerase
chain reaction (PCR) assay to confirm viral etiology of ARVI and to verify respiratory
viruses prior to the therapy.
If a patient meets all inclusion criteria and does not have any exclusion criteria, at Visit
1 (Day 1) he/she will be randomized into one of two groups: the 1st group patients will take
Anaferon according to the dosage regimen until the end of the study; the 2nd group patients
will take Placebo according to Anaferon dosage regimen until the end of the study.
The patients will be provided with a patient diary (paper or electronic) where daily they
will record axillary body temperature (using a Geratherm Classic thermometer) and each ARVI
symptom severity twice a day (in the morning and in the evening). In addition, antipyretic
administration (if applicable) as well as any possible worsening of the patient's condition
(if applicable, for safety evaluation/AEs documentation) will also be recorded in a patient
diary. An investigator will provide the instructions on filling out the diary and will help
the patient to make first records of ARVI symptom severity and body temperature in the diary.
Patients are observed up for 7 days (screening, randomization - 1 day, study therapy - 5
days, follow-up period - 2 days). During treatment and follow-up period two visits are
scheduled (at home or at the study site) on days 5 (Visit 2) and day 7 (Visit 3). At Visits 2
and 3, the investigator will carry out physical examination, record dynamics of ARVI symptoms
and concomitant therapy and check patient diaries.
Treatment compliance will be evaluated at Visit 3. During the study, symptomatic therapy and
therapy for underlying chronic conditions are allowed with the exception of the drugs
indicated in the section "Prohibited Concomitant Treatment".
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03039621 -
Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Acute Respiratory Viral Infections in Children
|
Phase 4 | |
| Completed |
NCT03830905 -
Study to Assess Efficacy and Safety of XC221 200 mg in the Treatment of Influenza or Other ARVI
|
Phase 2 | |
| Completed |
NCT03455491 -
Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections
|
Phase 2 | |
| Completed |
NCT04682444 -
Efficacy and Safety of Enisamium Iodide for the Treatment of Acute Respiratory Viral Infections, Including Influenza.
|
Phase 2/Phase 3 |