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

August 19, 2020 updated by: Ilad Alavi Darazam, Shahid Beheshti University of Medical Sciences
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ilad Alavi Darazam, MD
  • Phone Number: +98-914-149-1958
  • Email: ilad13@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm1
Lopinavir /Ritonavir +high dose Interferon-β 1a
High dose IFN-β1a (Recigen) (Subcutaneous injections of 88μg (24,000 IU) on days 1, 3, 6)
Lopinavir/Ritonavir (Kaletra) [IFN-β1a group] (400mg/100 mg twice a day for 10 days
EXPERIMENTAL: Arm2
Lopinavir /Ritonavir + Low dose Interferon-β 1a
Lopinavir/Ritonavir (Kaletra) [IFN-β1a group] (400mg/100 mg twice a day for 10 days
Low doseIFN-β1a (Recigen) (Subcutaneous injections of 44μg (12,000 IU) on days 1, 3, 6)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of randomization until 14 days later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SpO2 Improvement
Time Frame: Days 1, 2, 3, 4, 5, 6, 7 and 14
Pulse-oxymetry
Days 1, 2, 3, 4, 5, 6, 7 and 14
Mortality
Time Frame: From date of randomization until 14 days later
If the patient dies, we have reached an outcome
From date of randomization until 14 days later
Incidence of new mechanical ventilation use
Time Frame: From date of randomization until 14 days later
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
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
Days 1, 2, 3, 4, 5, 6, 7 and 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 20, 2020

Primary Completion (ANTICIPATED)

September 4, 2020

Study Completion (ANTICIPATED)

September 11, 2020

Study Registration Dates

First Submitted

August 18, 2020

First Submitted That Met QC Criteria

August 19, 2020

First Posted (ACTUAL)

August 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

August 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on High dose Interferon-beta 1a

3
Subscribe