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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
Sponsor:
Information provided by (Responsible Party):
Ilad Alavi Darazam, Shahid Beheshti University of Medical Sciences

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 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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: High dose Interferon-beta 1a Drug: Lopinavir/Ritonavir Drug: Low dose Interferon-beta 1a 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 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.

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm1
Lopinavir /Ritonavir +high dose Interferon-β 1a
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)




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 ]
  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 ]
  5. 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
Criteria

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

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): NCT04521400


Contacts
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Contact: Ilad Alavi Darazam, MD +98-914-149-1958 ilad13@yahoo.com

Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
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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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ilad Alavi Darazam, Shahid Beheshti University of Medical Sciences:
COVID-19
Interferons
Ritonavir
Lopinavir
Interferon-beta
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Additional relevant MeSH terms:
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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