Official Title
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
Brief 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.

*Inclusion Criteria: Age ≥ 18 COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed) Tympanic Temperature of ≥37.5 AND at least one of the following: Cough, Sputum production, nasal discharge, myalgia, headache or fatigue) on admission.

Time of onset of the symptoms should be acute ( Days ≤ 10) NEWS2 ≥ 1 on admission (National Early Warning Score 2)

*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.

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.

Enrolling by invitation
COVID-19

Drug: Hydroxychloroquine
This Drug will be used in all arms.
Control group: hydroxychloroquine + Lopinavir / Ritonavir
Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a
Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b

Drug: Lopinavir / Ritonavir
This Drug will be used in all arms.
Control group: hydroxychloroquine + Lopinavir / Ritonavir
Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a
Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b

Drug: Interferon Beta-1A
This drug will be only used in Arm 1.
Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a

Drug: Interferon Beta-1B
This drug will be only used in Arm 2.
Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b

Eligibility Criteria

Inclusion Criteria:

- Age ≥ 18

- COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed)

- Tympanic Temperature of ≥37.5 AND at least one of the following: Cough, Sputum production, nasal discharge, myalgia, headache or fatigue) on admission.

- Time of onset of the symptoms should be acute ( Days ≤ 10)

- NEWS2 ≥ 1 on admission (National Early Warning Score 2)

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
Iran, Islamic Republic of

Ilad Alavi Darazam, MD
Study Chair
Shahid Beheshti University of Medical Sciences

~

Shervin Shokouhi, MD
Study Director
Shahid Beheshti University of Medical Sciences

~

Minoosh Shabani, MD
Principal Investigator
Shahid Beheshti University of Medical Sciences

~

Mohammadreza Haji Esmaelie, MD
Principal Investigator
Shahid Beheshti University of Medical Sciences

~

Seyed Sina Naghibi Irvani, MD, MPH, MBA
Principal Investigator
Shahid Beheshti University of Medical Sciences

Shahid Beheshti University of Medical Sciences
NCT Number
Keywords
Covid-19
novel coronavirus
Interferon Beta 1a
Interferon Beta 1b
MeSH Terms
Interferons
Ritonavir
Lopinavir
Interferon-beta
Interferon beta-1a
Hydroxychloroquine
Interferon beta-1b