Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: COVID-19
Novel Coronavirus
Interferon Beta 1a
Interferon Beta 1b
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.

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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to clinical improvement
timeFrame: From date of randomization until 14 days later.
Secondary outcomes:
measure: Mortality
timeFrame: From date of randomization until 14 days later.
measure: SpO2 Improvement
timeFrame: Days 1, 2, 3, 4, 5, 6, 7 and 14.
measure: Incidence of new mechanical ventilation use
timeFrame: From date of randomization until 14 days later.
measure: Duration of hospitalization
timeFrame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days.
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Ilad Alavi Darazam, MD
role: STUDY_CHAIR
affiliation: Shahid Beheshti University of Medical Sciences
name: Shervin Shokouhi, MD
role: STUDY_DIRECTOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Minoosh Shabani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Mohammadreza Haji Esmaelie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Seyed Sina Naghibi Irvani, MD, MPH, MBA
role: PRINCIPAL_INVESTIGATOR
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