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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04350684
Other study ID # Umifenovir in COVID-19
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date April 15, 2020
Est. completion date April 24, 2020

Study information

Verified date April 2020
Source Shahid Beheshti University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Umifenovir
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.
Interferon-ß 1a
This Drug will be used in all arms as we discovered its benefits in our previous randomized clinical trial.
Lopinavir / Ritonavir
This Drug will be used in all arms as mandated by our governmental guidelines.
Single Dose of Hydroxychloroquine
This Drug will be used in all arms as mandated by our governmental guidelines.
Standards of Care
This Drug will be used in all arms as mandated by our governmental guidelines.

Locations

Country Name City State
Iran, Islamic Republic of Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services Tehran

Sponsors (1)

Lead Sponsor Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Mortality If the patient dies, we have reached an outcome. From date of randomization until 14 days later.
Secondary SpO2 Improvement Pulse-oxymetry Days 1, 2, 3, 4, 5, 6, 7 and 14.
Secondary Incidence of new mechanical ventilation use Incidence of new mechanical ventilation use From date of randomization until 14 days later.
Secondary Duration of hospitalization Duration of hospitalization (days) 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.
Secondary Cumulative incidence of serious adverse events With incidence of any serious adverse effects, the outcome has happened. Days 1, 2, 3, 4, 5, 6, 7 and 14.
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