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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-20

Study Completion Date

2020-09-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm1

Lopinavir /Ritonavir +high dose Interferon-β 1a

Group Type EXPERIMENTAL

High dose Interferon-beta 1a

Intervention Type DRUG

High dose IFN-β1a (Recigen) (Subcutaneous injections of 88μg (24,000 IU) on days 1, 3, 6)

Lopinavir/Ritonavir

Intervention Type DRUG

Lopinavir/Ritonavir (Kaletra) \[IFN-β1a group\] (400mg/100 mg twice a day for 10 days

Arm2

Lopinavir /Ritonavir + Low dose Interferon-β 1a

Group Type EXPERIMENTAL

Lopinavir/Ritonavir

Intervention Type DRUG

Lopinavir/Ritonavir (Kaletra) \[IFN-β1a group\] (400mg/100 mg twice a day for 10 days

Low dose Interferon-beta 1a

Intervention Type DRUG

Low doseIFN-β1a (Recigen) (Subcutaneous injections of 44μg (12,000 IU) on days 1, 3, 6)

Interventions

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High dose Interferon-beta 1a

High dose IFN-β1a (Recigen) (Subcutaneous injections of 88μg (24,000 IU) on days 1, 3, 6)

Intervention Type DRUG

Lopinavir/Ritonavir

Lopinavir/Ritonavir (Kaletra) \[IFN-β1a group\] (400mg/100 mg twice a day for 10 days

Intervention Type DRUG

Low dose Interferon-beta 1a

Low doseIFN-β1a (Recigen) (Subcutaneous injections of 44μg (12,000 IU) on days 1, 3, 6)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Ilad Alavi Darazam

Dr. Ilad Alavi Darazam, MD

Responsibility Role PRINCIPAL_INVESTIGATOR