Status:
UNKNOWN
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
Lead Sponsor:
Shahid Beheshti University of Medical Sciences
Conditions:
Covid19
Eligibility:
All Genders
18-100 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 (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
- 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
Key Trial Info
Start Date :
August 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 11 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04521400
Start Date
August 20 2020
End Date
September 11 2020
Last Update
August 20 2020
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