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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 (COVIFERON)

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ClinicalTrials.gov Identifier: NCT04343768
Recruitment Status : Completed
First Posted : April 13, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Seyed Sina Naghibi Irvani, MD, MPH, MBA, Senior Researcher., Shahid Beheshti University of Medical Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine Drug: Lopinavir / Ritonavir Drug: Interferon Beta-1A Drug: Interferon Beta-1B Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 9, 2020
Actual Primary Completion Date : April 27, 2020
Actual Study Completion Date : April 27, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a 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.
Experimental: Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b Drug: Hydroxychloroquine
This Drug will be used in all arms.

Drug: Lopinavir / Ritonavir
This Drug will be used in all arms.

Drug: Interferon Beta-1B
This drug will be only used in Arm 2.
Active Comparator: Control group: hydroxychloroquine + Lopinavir / Ritonavir Drug: Hydroxychloroquine
This Drug will be used in all arms.

Drug: Lopinavir / Ritonavir
This Drug will be used in all arms.


Outcome Measures
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Primary Outcome Measures :
  1. Time to clinical improvement [ Time Frame: From date of randomization until 14 days later. ]
    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.


Secondary Outcome Measures :
  1. Mortality [ Time Frame: From date of randomization until 14 days later. ]
    If the patient dies, we have reached an outcome.

  2. SpO2 Improvement [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7 and 14. ]
    Pulse-oxymetry

  3. Incidence of new mechanical ventilation use [ Time Frame: From date of randomization until 14 days later. ]
    Incidence of new mechanical ventilation use

  4. Duration of hospitalization [ Time Frame: 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. ]
    Duration of hospitalization (days)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04343768


Locations
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Iran, Islamic Republic of
Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
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Study Chair: Ilad Alavi Darazam, MD Shahid Beheshti University of Medical Sciences
Study Director: Shervin Shokouhi, MD Shahid Beheshti University of Medical Sciences
Principal Investigator: Minoosh Shabani, MD Shahid Beheshti University of Medical Sciences
Principal Investigator: Mohammadreza Haji Esmaelie, MD Shahid Beheshti University of Medical Sciences
Principal Investigator: Seyed Sina Naghibi Irvani, MD, MPH, MBA Shahid Beheshti University of Medical Sciences
More Information
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Additional Information:

Publications:

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Responsible Party: Seyed Sina Naghibi Irvani, MD, MPH, MBA, Senior Researcher., Dr., Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04343768    
Other Study ID Numbers: Different Interferons in COVID
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: One year after the publication of the results in a journal, Qualifying researchers who reach out to Dr. Seyed Sina Naghibi Irvani at "sina.irvani@sbmu.ac.ir" or "sina.irvani@gmail.com" and submit a proposal with a valuable research question can have access to data and supporting information.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: One year after the publication of the results in a journal.
Access Criteria: Qualifying researchers who reach out to Dr. Seyed Sina Naghibi Irvani at "sina.irvani@sbmu.ac.ir" or "sina.irvani@gmail.com" and submit a proposal with a valuable research question.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Seyed Sina Naghibi Irvani, MD, MPH, MBA, Senior Researcher., Shahid Beheshti University of Medical Sciences:
COVID-19
Novel Coronavirus
Interferon Beta 1a
Interferon Beta 1b
Additional relevant MeSH terms:
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Interferons
Ritonavir
Lopinavir
Interferon-beta
Interferon beta-1a
Hydroxychloroquine
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Antirheumatic Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic