Acute respiratory infection (ARI)
Conditions
Interventions
Stage I
Group A (Experimental): 2 drops (0.10 mL, 500,000 IU Nasalferon) in each nostril, 2 times a day, for 10 days. Total daily dose: 2 million IU.
Group B (Experimental): 1 drop (0.05 mL, 250,000 I
Placebos
Administration, Intranasal
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB)
Cuban Ministry of Public Health (MINSAP)
Eligibility
Sex/Gender
All
Age
19 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.- Clinical diagnosis of AKI with mild symptoms (non-sustained fever = 38 ºC, cough, sore throat, sneezing, nasal congestion, mild headache, mild body aches, malaise, diarrhea and/or vomiting. White nasal discharge (clear ) or transparent Radiology (Rx) normal Oxygen saturation greater than 95%). 2.- Age between 19 and 80 years, regardless of sex or skin color. 3.- Time not greater than 48 hours from the onset of clinical respiratory symptoms. 4.- Willingness of the patient to participate in the trial.
Exclusion criteria
Exclusion criteria: 1.- Individuals under 19 years of age and over 80. 2.- Individuals with suspected clinical diagnosis of AKI with bacterial etiology. 3.- Individual with a clinical diagnosis of AKI with mild symptoms, without having started treatment within 48 hours after the onset of symptoms. 4.- Individuals with symptoms of AKI in moderate, severe or critical clinical classification. 5.- Individuals with chronic decompensated disease. 6.- Treatment with immunosuppressants in the last month prior to inclusion. 7.- Ongoing treatment, for any reason, with any formulation of IFN alpha. 8.- Active use of some other drug or substance intranasally. 9.- Patient diagnosed with Myasthenia Gravis. 10.- Administration of an investigational drug in the 30 days prior to inclusion in the study. 11.- Individuals with hypersensitivity to thiomersal (thimerosal). 12.- Individuals with hypersensitivity to interferon alfa. 13.- Evident mental inability to give consent and act accordingly with the study. 14.- Pregnancy, puerperium or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient Recovery (Recovered patient: PCR negative for AKI of viral aetiology and absence of clinical symptoms of AKI. Non-recovered patient: PCR positive for AKI of viral aetiology or presence of clinical symptoms of AKI). Measurement time: 8th day after starting treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.- Clinical response (disappearance of clinical respiratory symptoms). Measurement time: Daily during the treatment time of the patient. 2.- Virological response (PCR negative for ARI of viral aetiology). Measurement time: on the 8th and 11th day of starting treatment. 3.- Proportion of recovered patients (Quotient number of patients recovered/number of patients included). Measurement time: 8th and 11th day of starting treatment. | — |
Countries
Cuba
Contacts
Public ContactHugo Nodarse Cuni
Center for Genetic Engineering and Biotechnology
Outcome results
None listed