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.
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.
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.
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.
Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services
Tehran, Iran, Islamic Republic of