Status:
UNKNOWN
Umifenovir in Hospitalized COVID-19 Patients
Lead Sponsor:
Shahid Beheshti University of Medical Sciences
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The present study is a randomized, double-blind, placebo-controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-1...
Detailed Description
Umifenovir is a component derived from indole, which has showed positive efficacy in inhibition of virus-to-host cell attachment in different groups of influenza, and type C hepatitis virus. Another s...
Eligibility Criteria
Inclusion
- Age ≥ 18
- COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed).
- Tympanic Temperature of ≥37.5 AND at least one of the following: Cough, Sputum production, nasal discharge, myalgia, headache or fatigue) on admission.
- Time of onset of the symptoms should be acute ( Days ≤ 10).
- SpO2 ≤ 93%
- Respiratory Rate ≥ 22
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 Umifenovir Hydroxychloroquine, 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.
Key Trial Info
Start Date :
April 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 24 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04350684
Start Date
April 15 2020
End Date
April 24 2020
Last Update
April 20 2020
Active Locations (1)
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1
Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services
Tehran, Iran