asalferon in COVID-19

Phase 2

Suspended

• Conditions: COVID-19; SARS-CoV-2; Coronavirus Infections; SARS Virus; Coronaviridae Infections; Nidovirales Infections; Betacoronavirus

• Registration Number: RPCEC00000399
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-12
• Study Completion: 2022-01-31
• Results First Posted: 2022-03-31
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

1. Virological diagnosis by RT-PCR of infection with SARS-CoV-2.
2. Age between 19 and 80 years, without distinction of sex or skin color.
3. Mild stage COVID-19 patients.
4. Time no longer than 48 hours from the onset of clinical respiratory symptoms.
5. Informed consent of the patient or legal representative

Exclusion Criteria

1. Individual with PCR positive for SARS-CoV-2 without having started treatment within 48 hours after the onset of symptoms.
2. Individuals under the age of 19 and over the age of 80.
3. Individuals with COVID-19 in moderate, severe or critical stage.
4. Individuals with decompensated chronic disease.
5. Immunosuppressant treatment in the last month prior to enrollment.
6. Ongoing treatment, for any cause, with any IFN formulation.
7. Use of any other medication or substance intranasally.
8. Patients with myasthenia gravis.
9. Administration of an investigational drug in the 30 days prior to inclusion in the study.
10. Individuals with hypersensitivity to thiomersal (thimerosal).
11. Individuals with hypersensitivity to interferon alpha.
12. Obvious mental incapacity to give consent and act accordingly with the study.
13. Pregnancy, puerperium or lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified