Umifenovir in Hospitalized COVID-19 Patients

• Status: Enrolling by invitation
• Trial end date: 2020-04-24
• Target enrollment: 0
• Participant gender: All

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-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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shahid Beheshti University of Medical Sciences
• Treatments: Hydroxychloroquine; Interferon beta-1a; Interferon-beta; Interferons; Lopinavir; Ritonavir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.