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 Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Hydroxychloroquine
* Drug: Lopinavir / Ritonavir
* Drug: Interferon Beta-1A
* Drug: Interferon Beta-1B


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a<br> | Drug: Hydroxychloroquine<br>* This Drug will be used in all arms.<br>Drug: Lopinavir / Ritonavir<br>* This Drug will be used in all arms.<br>Drug: Interferon Beta-1A<br>* This drug will be only used in Arm 1.<br>|
| Experimental: Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b<br> | Drug: Hydroxychloroquine<br>* This Drug will be used in all arms.<br>Drug: Lopinavir / Ritonavir<br>* This Drug will be used in all arms.<br>Drug: Interferon Beta-1B<br>* This drug will be only used in Arm 2.<br>|
| Active Comparator: Control group: hydroxychloroquine + Lopinavir / Ritonavir<br> | Drug: Hydroxychloroquine<br>* This Drug will be used in all arms.<br>Drug: Lopinavir / Ritonavir<br>* This Drug will be used in all arms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clinical improvement | Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first. | From date of randomization until 14 days later. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | If the patient dies, we have reached an outcome. | From date of randomization until 14 days later. | 
| SpO2 Improvement | Pulse-oxymetry | Days 1, 2, 3, 4, 5, 6, 7 and 14. | 
| Incidence of new mechanical ventilation use | Incidence of new mechanical ventilation use | From date of randomization until 14 days later. | 
| Duration of hospitalization | Duration of hospitalization (days) | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Novel Coronavirus, COVID-19, Interferon Beta 1a, Interferon Beta 1b