the Investigation Into Beneficial Effects of High-dose Interferon Beta 1-a, Compared to Low-dose Interferon Beta 1-a in Moderate to Severe Covid-19
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ClinicalTrials.gov Identifier: NCT04521400 |
Recruitment Status :
Not yet recruiting
First Posted : August 20, 2020
Last Update Posted : August 20, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Covid19 | Drug: High dose Interferon-beta 1a Drug: Lopinavir/Ritonavir Drug: Low dose Interferon-beta 1a | 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 high-dose Interferon Beta 1a, Compared to low-dose Interferon Beta 1a (the base therapeutic regimen) in Moderate to Severe COVID-19.
Previous studies demonstrate that IFN-β 1a could be used against some coronaviruses including avium infectious, bronchitis virus, murine hepatitis virus, and SARS- CoV because they are susceptible in vitro or in vivo. In a current study, the efficacy of IFN-β 1a in COVID-19 patients were evaluated, and they found than IFN-β 1a reduced the disease symptoms.
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | the Investigation Into Beneficial Effects of High-dose Interferon Beta 1-a, Compared to Low-dose Interferon Beta 1-a in Moderate to Severe Covid-19 |
Estimated Study Start Date : | August 20, 2020 |
Estimated Primary Completion Date : | September 4, 2020 |
Estimated Study Completion Date : | September 11, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm1
Lopinavir /Ritonavir +high dose Interferon-β 1a
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Drug: High dose Interferon-beta 1a
High dose IFN-β1a (Recigen) (Subcutaneous injections of 88μg (24,000 IU) on days 1, 3, 6) Drug: Lopinavir/Ritonavir Lopinavir/Ritonavir (Kaletra) [IFN-β1a group] (400mg/100 mg twice a day for 10 days |
Experimental: Arm2
Lopinavir /Ritonavir + Low dose Interferon-β 1a
|
Drug: Lopinavir/Ritonavir
Lopinavir/Ritonavir (Kaletra) [IFN-β1a group] (400mg/100 mg twice a day for 10 days Drug: Low dose Interferon-beta 1a Low doseIFN-β1a (Recigen) (Subcutaneous injections of 44μg (12,000 IU) on days 1, 3, 6) |
- 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 ]
- 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 ]
- Cumulative incidence of serious adverse events [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7 and 14 ]With the incidence of any serious adverse effects, the outcome has happened

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age ≥ 18
- COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed)
- at least one of the following: radiation contactless body temperature ≥37.5, cough, shortness of breath, nasal congestion/ discharge, myalgia/arthralgia, diarrhea/vomiting, headache or fatigue on admission.
- Time of onset of the symptoms should be acute (Days ≤ 14)
- NEWS2 ≥ 1 on admission (National Early Warning Score 2)
Exclusion Criteria:
- Refusal to participate expressed by patient or legally authorized representative if they are present
- Patients using drugs with potential interaction with Lopinavir/Ritonavir or Interferon-β 1a
- 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.
- The patients who were intubated less than one hours after admission to the hospital

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): NCT04521400
Contact: Ilad Alavi Darazam, MD | +98-914-149-1958 | ilad13@yahoo.com |
Study Chair: | Ilad Alavi Darazam, M.D | Shahid Beheshti University of Medical Sciences | |
Principal Investigator: | Firouze Hatami, M.D | Shahid Beheshti University of Medical Sciences | |
Principal Investigator: | Mohammad Mahdi Rabiei, M.D | Shahid Beheshti University of Medical Sciences | |
Principal Investigator: | Omid Moradi | Shahid Beheshti University of Medical Sciences | |
Principal Investigator: | Behnam Rahimi, M.D | Shahid Beheshti University of Medical Sciences | |
Study Director: | Shervin Shokouhi, M.D | Shahid Beheshti University of Medical Sciences | |
Principal Investigator: | Mohammad Reza Hajesmaeili, M.D | Shahid Beheshti University of Medical Sciences | |
Principal Investigator: | Minoosh Shabani, M.D | Shahid Beheshti University of Medical Sciences | |
Principal Investigator: | Seyed Sina Naghibi Irvani, M.D | Shahid Beheshti University of Medical Sciences |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Ilad Alavi Darazam, Dr. Ilad Alavi Darazam, MD, Shahid Beheshti University of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT04521400 |
Other Study ID Numbers: |
Interferon in COVID |
First Posted: | August 20, 2020 Key Record Dates |
Last Update Posted: | August 20, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Interferons Ritonavir Lopinavir |
Interferon-beta Antiviral Agents Anti-Infective Agents Immunologic Factors |
Interferons Ritonavir Lopinavir Interferon-beta Interferon beta-1a 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 Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic |