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: 19 August 2024

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

Primary Outcome Measures

Name	Time	Method
Recovered patient (SARS-CoV-2 PCR negative in the absence of major symptoms of upper respiratory infection). Measurement time: on the 3rd day, 5th day, 7th day and 9th day after starting the treatment.

Secondary Outcome Measures

Name	Time	Method
1. Speed of response to treatment (Moment of first negative PCR during treatment). Measurement time: on the 3rd day, 5th day, 7th day and 9th day after starting the treatment.<br>2. Proportion of patients recovered (ratio of number of patients recovered / number of patients included). Measurement time: at hospital discharge.<br>3. Severity of the disease (Duration and intensity of COVID-19 symptoms). Measurement time: daily during the time of hospitalization of the patient.