Interferon Beta 1a in Hospitalized COVID-19 Patients (IB1aIC)
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ClinicalTrials.gov Identifier: NCT04350671 |
Recruitment Status :
Enrolling by invitation
First Posted : April 17, 2020
Last Update Posted : April 20, 2020
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Drug: Interferon Beta-1A Drug: Lopinavir / Ritonavir Drug: Single Dose of Hydroxychloroquine | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | The present study is a randomized, double-blind, placebo-controlled, 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 two 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. |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial |
Estimated Study Start Date : | April 15, 2020 |
Estimated Primary Completion Date : | April 20, 2020 |
Estimated Study Completion Date : | April 24, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Interferon-β 1a
Interferon-β 1a + Lopinavir / Ritonavir + Single Dose of Hydroxychloroquine
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Drug: Interferon Beta-1A
This will be drug only used in the intervention arm of our study, designed mainly to assess the additional efficacy and safety of Interferon-β 1a in COVID-19 patients. Drug: Lopinavir / Ritonavir This Drug will be used in all arms as mandated by our governmental guidelines. Drug: Single Dose of Hydroxychloroquine This Drug will be used in all arms as mandated by our governmental guidelines. |
Active Comparator: Control
Lopinavir / Ritonavir + Single Dose of Hydroxychloroquine
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Drug: Lopinavir / Ritonavir
This Drug will be used in all arms as mandated by our governmental guidelines. Drug: Single Dose of Hydroxychloroquine This Drug will be used in all arms as mandated by our governmental guidelines. |
- 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)
- Cumulative incidence of serious adverse events [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7 and 14. ]With incidence of any serious adverse effects, the outcome has happened.

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 50
- COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed).
- Tympanic Temperature of ≥37.5 AND at least one of the following: Cough, Sputum production, nasal discharge, myalgia, headache or fatigue) on admission.
- Time of onset of the symptoms should be acute ( Days ≤ 10).
- SpO2 ≤ 88%
- Respiratory Rate ≥ 24
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 Umifenovir Hydroxychloroquine, 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.

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): NCT04350671
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 |
Responsible Party: | Seyed Sina Naghibi Irvani, MD, MPH, MBA, Senior Researcher., Dr., Shahid Beheshti University of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT04350671 |
Other Study ID Numbers: |
Interferon Beta 1a in COVID-19 |
First Posted: | April 17, 2020 Key Record Dates |
Last Update Posted: | April 20, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | There is no further information. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Novel Coronavirus Interferon Beta 1a Lopinavir/Ritonavir Kaletra |
Chloroquine Hydroxychloroquine Interferon SARS-CoV-2 2019-nCoV |
Interferons Ritonavir Lopinavir Interferon-beta Interferon beta-1a Hydroxychloroquine 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 |