An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial (COVIFERON)

Shahid Beheshti University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Drug: Interferon Beta-1A; Drug: Interferon Beta-1B; Drug: Hydroxychloroquine; Drug: Lopinavir / Ritonavir

Study type: Interventional

Funder types: Other

Identifiers

NCT04343768

Different Interferons in COVID

Details and patient eligibility

About

The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be randomly assigned to the three arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.

Full description

According to previous studies, IFN-β has strong antiviral activity and also has an acceptable safety profile. Based on possible therapeutic effects, We decided to lead An Investigation into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19. In a 2003 study, SARS was treated with different human interferons and found that IFN-β was 5 to 10 times more effective than other types of interferons and the strongest antiviral drug possible against SARS-CoV.

The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran.

Patients will be allocated to three therapeutic arms (Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a group and Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b group and the Base Therapeutic Regiment Group, i.e., Hydropinchloroquine + / Ritonavir. For this purpose, we will use the method of Balance Block Randomization for three groups.

After completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18
• COVID-19 Confirmed Cases By Means of RT-PCR
• Oxygen saturation (SPO2) ≤ 93% OR respiratory rate ≥ 24
• At least one of the following: Calibrated contactless infrared forehead thermometry temperature of ≥37.8, cough, sputum production, nasal discharge, myalgia, headache or fatigue on admission.
• Time of onset of the symptoms should be acute ( Days ≤ 14)

Exclusion criteria

• Refusal to participate expressed by patient or legally authorized representative if they are present
• Patients with prolonged QT or PR intervals, Second or Third Degree heart block, Arrhythmias including torsade de pointes
• Patients using drugs with potential interaction with Hydroxychloroquine + Lopinavir/Ritonavir, Interferon-β 1a، Interferon-β 1b.
• Pregnant or lactating women.
• History of alcohol or drug addiction in the past 5 years.
• Blood ALT/AST levels > 5 times the upper limit of normal on laboratory results.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 3 patient groups

Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a

Experimental group

Treatment:

Drug: Interferon Beta-1A

Drug: Lopinavir / Ritonavir

Drug: Hydroxychloroquine

Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b

Experimental group

Treatment:

Drug: Interferon Beta-1B

Drug: Lopinavir / Ritonavir

Drug: Hydroxychloroquine

Control group: hydroxychloroquine + Lopinavir / Ritonavir

Active Comparator group

Treatment:

Drug: Lopinavir / Ritonavir

Drug: Hydroxychloroquine