Clinical trial NCT04521400: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Covid19
Keywords: COVID-19
Interferons
Ritonavir
Lopinavir
Interferon-beta
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Time to clinical improvement
timeFrame: From date of randomization until 14 days later
Secondary outcomes:
measure: Mortality
timeFrame: From date of randomization until 14 days later
measure: SpO2 Improvement
timeFrame: Days 1, 2, 3, 4, 5, 6, 7 and 14
measure: Incidence of new mechanical ventilation use
timeFrame: From date of randomization until 14 days later
measure: Duration of hospitalization
timeFrame: 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
measure: Cumulative incidence of serious adverse events
timeFrame: Days 1, 2, 3, 4, 5, 6, 7 and 14
Other outcomes:
Locations:
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Ilad Alavi Darazam, M.D
role: STUDY_CHAIR
affiliation: Shahid Beheshti University of Medical Sciences
name: Firouze Hatami, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Mohammad Mahdi Rabiei, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Omid Moradi
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Behnam Rahimi, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Shervin Shokouhi, M.D
role: STUDY_DIRECTOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Mohammad Reza Hajesmaeili, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Minoosh Shabani, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Seyed Sina Naghibi Irvani, M.D
role: PRINCIPAL_INVESTIGATOR
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