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 |
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Recruitment Status :
Completed
First Posted : April 13, 2020
Last Update Posted : May 5, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 | Drug: Hydroxychloroquine Drug: Lopinavir / Ritonavir Drug: Interferon Beta-1A Drug: Interferon Beta-1B | Phase 2 |
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 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 |
| 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. |
- 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.
- Mortality [ Time Frame: From date of randomization until 14 days later. ]If the patient dies, we have reached an outcome.
- SpO2 Improvement [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7 and 14. ]Pulse-oxymetry
- Incidence of new mechanical ventilation use [ Time Frame: From date of randomization until 14 days later. ]Incidence of new mechanical ventilation use
- 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)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
| Iran, Islamic Republic of | |
| Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services | |
| Tehran, Iran, Islamic Republic of | |
| 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 |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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. |
| 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 |
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COVID-19 Novel Coronavirus Interferon Beta 1a Interferon Beta 1b |
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COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Interferons Ritonavir Lopinavir |
Interferon-beta Interferon beta-1a Hydroxychloroquine Interferon beta-1b Antineoplastic Agents Antiviral Agents Anti-Infective Agents HIV Protease Inhibitors Viral Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Cytochrome P-450 CYP3A Inhibitors |