Acute respiratory infection
Conditions
Interventions
Nasalferon 5M (recombinant human interferon alpha 2b - IFN-a2b) (Experimental group): 1 drop (0.05 mL
250,000 IU IFN-a2b) in each nostril every 8 hours (1.5 MIU IFN-a2b daily) for 5 days. If respiratory symptoms persist on the 5th day, continue treatment for 10 days.
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Compliance with diagnostic criteria (uncomplicated acute upper respiratory infection, with clinical symptoms suggestive of viral etiology, presenting at least one of the following respiratory symptoms: nasal obstruction, rhinorrhea, odynophagia, and fever. These symptoms may be accompanied by pharyngeal erythema, dry or wet cough with whitish or clear expectoration, coryza or sneezing, asthenia, myalgia, and headache). 2) Age equal or older than =19 years. 3) Time no longer than 48 hours since the onset of clinical symptoms. 4) Patient willingness to participate in the clinical trial.
Exclusion criteria
Exclusion criteria: 1) Patients with low or complicated ARI symptoms, according to the modified Denny and Clyde classification. 2) Patient with clinical symptoms suspected of ARI of bacterial etiology. 3) Patients treated with immunomodulators or antivirals one month prior to inclusion. 4) Oncology patients with a history of chemotherapy less than two months prior to inclusion. 5) Patient with administration of any other biological product, included in another clinical trial. 6) Patient with obstructive nasal disease, referred (example: polyps). 7) History of recurrent episodes of nasal bleeding. 8) Known hypersensitivity to thiomersal and any of the components of the formulation under study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resolution or improvement (percentage of patients) of the main respiratory symptoms (odynophagia, nasal obstruction, rhinorrhea, fever). Time of measurement: on the 3rd or 5th day after starting treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Time of evolution (days) of each of the symptoms associated with ARI and identified at the time of inclusion of the patient in the study. Time of measurement: daily, until the cessation or improvement of each symptom. 2) Percentage of patients with resolution of main respiratory symptoms. Time of measurement: 7th and 12th after starting treatment. 3) Appearance of complications specific to the disease under study, after the start of treatment (type and duration [days]). Special attention will be paid to the warning signs of acute respiratory infections (polypnea at rest >32/min, indrawing, central cyanosis, laryngeal stridor, temperature ?35.5 °C or >39.0 °C, behavioral changes [great adynamia or psychomotor agitation], hemodynamic disorders, purulent or hemoptoic expectoration, chest pain, wheezing or chest tightness). 4) Clinical Adverse Events-AE (These will be measured as: -Occurrence of AE (Yes, No), -Description of the AE (name of the event), -Intensity of the AE (mild, moderate, severe), -Causal relationship (unrelated, doubtful, possible, probable, definite), -Measures adopted (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Exit from the study, Hospitalization/prolongation of hospitalization), -Outcome (Completely resolved, Resolved with sequelae, Conditions improving, Condition present and unchanged, Worsening, Death caused by this event)). Measurement time: at 72 hours, as well as on the 5th, 7th and 12th day (in person at the clinical site, with review of the outpatient adverse event card, in the possession of each patient). | — |
Countries
Cuba
Contacts
Public ContactFrancisco Hernandez Bernal
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed