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

Shahid Beheshti University of Medical Sciences

Status and phase: Unknown; Phase 2

Conditions: Covid19

Treatments: Drug: Low dose Interferon-beta 1a; Drug: Lopinavir/Ritonavir; Drug: High dose Interferon-beta 1a

Study type: Interventional

Funder types: Other

Identifiers

NCT04521400

Interferon in COVID

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Arm1

Experimental group

Description:

Lopinavir /Ritonavir +high dose Interferon-β 1a

Treatment:

Drug: Lopinavir/Ritonavir

Drug: High dose Interferon-beta 1a

Arm2

Experimental group

Description:

Lopinavir /Ritonavir + Low dose Interferon-β 1a

Treatment:

Drug: Lopinavir/Ritonavir

Drug: Low dose Interferon-beta 1a