Status:
COMPLETED
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
Lead Sponsor:
Shahid Beheshti University of Medical Sciences
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Educatio...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04343768
Start Date
April 9 2020
End Date
April 27 2020
Last Update
May 5 2020
Active Locations (1)
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1
Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services
Tehran, Iran