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NCT Number: NCT04343768

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydroxychloroquine

Drug

This Drug will be used in all arms.

Lopinavir / Ritonavir

Drug

This Drug will be used in all arms.

Interferon beta-1a

Drug

This drug will be only used in Arm 1.

Interferon beta-1b

Drug

This drug will be only used in Arm 2.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Acronym: COVIFERON

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2020
Registry last updated
May 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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