Umifenovir in Hospitalized COVID-19 Patients

NCT04350684 | Unknown Phase 4 DMC

• 1 other identifier: Umifenovir in COVID-19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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-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.

Conditions

COVID-19

Keywords

COVID-19; Novel Coronavirus; Umifenovir; Interferon Beta 1a; Arbidol; Lopinavir/Ritonavir; Kaletra; Chloroquine; Hydroxychloroquine; Interferon

Outcome Measures

Primary Outcomes (1)

• Time to clinical improvement

  Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R\&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first.

  From date of randomization until 14 days later.

Secondary Outcomes (5)

• Mortality

  From date of randomization until 14 days later.

• SpO2 Improvement

  Days 1, 2, 3, 4, 5, 6, 7 and 14.

• Incidence of new mechanical ventilation use

  From date of randomization until 14 days later.

• Duration of hospitalization

  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.

• Cumulative incidence of serious adverse events

  Days 1, 2, 3, 4, 5, 6, 7 and 14.

Study Arms (2)

Umifenovir

EXPERIMENTAL

Umifenovir + Interferon-β 1a + Lopinavir / Ritonavir + Single Dose of Hydroxychloroquine + Standards of Care

Drug: Umifenovir; Drug: Interferon-β 1a; Drug: Lopinavir / Ritonavir; Drug: Single Dose of Hydroxychloroquine; Drug: Standards of Care

Control

ACTIVE COMPARATOR

Interferon-β 1a + Lopinavir / Ritonavir + Single Dose of Hydroxychloroquine + Standards of Care

Drug: Interferon-β 1a; Drug: Lopinavir / Ritonavir; Drug: Single Dose of Hydroxychloroquine; Drug: Standards of Care

Interventions

Umifenovir DRUG

This will be drug only used in the intervention arm of our study, designed mainly to assess the additional efficacy and safety of Umifenovir in COVID-19 patients.

Umifenovir

Interferon-β 1a DRUG

This Drug will be used in all arms as we discovered its benefits in our previous randomized clinical trial.

Control; Umifenovir

Lopinavir / Ritonavir DRUG

This Drug will be used in all arms as mandated by our governmental guidelines.

Control; Umifenovir

Single Dose of Hydroxychloroquine DRUG

This Drug will be used in all arms as mandated by our governmental guidelines.

Control; Umifenovir

Standards of Care DRUG

This Drug will be used in all arms as mandated by our governmental guidelines.

Control; Umifenovir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services

Tehran, Iran

Location

Related Publications (1)

• Alavi Darazam I, Shokouhi S, Mardani M, Pourhoseingholi MA, Rabiei MM, Hatami F, Shabani M, Moradi O, Gharehbagh FJ, Irvani SSN, Amirdosara M, Hajiesmaeili M, Rezaei O, Khoshkar A, Lotfollahi L, Gachkar L, Dehbsneh HS, Khalili N, Soleymaninia A, Kusha AH, Shoushtari MT, Torabinavid P. Umifenovir in hospitalized moderate to severe COVID-19 patients: A randomized clinical trial. Int Immunopharmacol. 2021 Oct;99:107969. doi: 10.1016/j.intimp.2021.107969. Epub 2021 Jul 10.

  PMID: 34273635 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

umifenovir; Lopinavir; Hydroxychloroquine; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Shervin Shokouhi, MD

  Shahid Beheshti University of Medical Sciences

  STUDY CHAIR

• Ilad Alavi Darazam, MD

  Shahid Beheshti University of Medical Sciences

  STUDY DIRECTOR

• Minoosh Shabani, MD

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Mohammadreza Haji Esmaelie, MD

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Latif Gachkar, MD

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Mahdi Amirdosara, MD

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Masoud Mardani, MD

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Seyed Sina Naghibi Irvani, MD, MPH, MBA

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 17, 2020
• Study Start: April 15, 2020
• Primary Completion: April 22, 2020
• Study Completion: April 24, 2020
• Last Updated: April 20, 2020

Record last verified: 2020-04

Locations

IR (1)