asal recombinant human interferon alfa-2b in ARI

Phase 2

Not yet recruiting

• Conditions: acute respiratory infection; Respiratory Tract Infections; Respiratory Tract Diseases; Infections

• Registration Number: RPCEC00000412
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-06
• Study Completion: 2023-12-30
• Results First Posted: 2024-02-29
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 608

Inclusion Criteria

1.- Clinical diagnosis of ARI with mild symptoms (non-sustained fever = 38 ºC, cough, sore throat, sneezing, nasal congestion, mild headache, mild body pain, 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 gender or skin color. 3.- Time not greater than 48 hours from the onset of clinical respiratory symptoms. 4.- Voluntary nature of the patient to participate in the trial.

Exclusion Criteria

1.- Individuals under 19 years of age and over 80. 2.- Individuals with suspected clinical diagnosis of ARI with bacterial etiology. 3.- Individual with a clinical diagnosis of ARI with mild symptoms, without having started treatment in the 48 hours after the onset of symptoms. 4.- Individuals with ARI symptoms in moderate, severe or critical clinical classification. 5.- Individuals with decompensated chronic disease. 6.- Treatment with immunosuppressants in the last month prior to inclusion. 7.- Ongoing treatment, for any reason, with some IFN alpha formulation. 8.- Active use of any other medication or substance intranasally. 9.- Patient diagnosed with Myasthenia Gravis. 10.- Administration of any investigational drug in the 30 days prior to inclusion in the study. 11.- Individuals with hypersensitivity to thiomersal (thimerosal). 12.- Individuals with hypersensitivity to alpha interferon. 13.- Evident mental incapacity to issue consent and act accordingly with the study. 14.- Pregnancy, puerperium or lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified