NCT04343768

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	This Drug will be used in all arms.
DRUG	Lopinavir / Ritonavir	This Drug will be used in all arms.
DRUG	Interferon Beta-1A	This drug will be only used in Arm 1.
DRUG	Interferon Beta-1B	This drug will be only used in Arm 2.

Timeline

• Start date: 2020-04-09
• Primary completion: 2020-04-27
• Completion: 2020-04-27
• First posted: 2020-04-13
• Last updated: 2020-05-05

Locations

1 site across 1 country: Iran