asal recombinant human interferon alfa-2b in ARI

Phase 2

• 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: 19 August 2024

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

Primary Outcome Measures

Name	Time	Method
Patient recovery (Patient recovered: PCR negative for ARI of viral etiology and absence of clinical symptoms of ARI. Patient not recovered: PCR positive for ARI of viral etiology or presence of clinical symptoms of ARI). Measurement time: 3rd day, 8th day and 10th day after starting the treatment

Secondary Outcome Measures

Name	Time	Method
1.- Clinical response (disappearance of clinical respiratory symptoms). Measurement time: Daily during the patient's treatment time. 2.- Virological response (negative PCR for ARI of viral etiology). Measurement time: on the 8th and 11th day after starting treatment. 3.- Severity of the disease (Classification of the disease into mild, moderate, severe and critical stages). Measurement time: Daily during the patient's treatment time. 4. Post-treatment clinical response (absence of clinical respiratory symptoms since the previous evaluation). Measurement time: on day 28 (week 4), day 56 (week 8) and day 84 (week 12) after the treatment was completed. 5. Security variables (Detection of adverse events during the physical examination of the patient or referrals). Measurement time: Daily during the patient's treatment time