Viewing Study NCT04714515



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Last Modification Date: 2024-10-26 @ 1:54 PM
Study NCT ID: NCT04714515
Status: COMPLETED
Last Update Posted: 2021-01-19
First Post: 2020-09-19

Brief Title: Montelukast - a Treatment Choice for COVID-19
Sponsor: University of Sargodha
Organization: University of Sargodha

Study Overview

Official Title: Using Montelukast to Treat the Patients Infected With Severe Acute Respiratory Syndrome Coronavirus 2 SARS-CoV-2
Status: COMPLETED
Status Verified Date: 2021-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The current study aimed to make a therapeutic comparison and effectiveness of Hydroxychloroquine HCQ and Montelukast ML in COVID-19 patients in addition to the standard of care The safety and efficacy of HCQ and ML will be assessed as individual therapy and in combination with each other and with the standard of care Cytokine storm Interleukin levels also will be monitored throughout the study to assess treatment progression
Detailed Description: To date no specific medication is available for COVID-19 Many FDA-approved drugs including antivirals antibacterials and anti-inflammatory compositions are being tested with the intention of repurposing against COVID-19 In this study investigators have evaluated the effectiveness of Hydroxychloroquine HCQ and Montelukast ML in an individual and combination therapy

Investigators have performed an observational study of 100 hospitalized COVID-19 patients while assessing the safety and efficacy of HCQ ML and IV as individual therapy and in combination with each other ECG interleukin levels LFTs blood profiles were continuously monitored throughout the study

The aim was to observe participants treated with ML and monitor the inflammatory markers to see whether they increase or decrease and whether an increase in survival rate is observed The findings have shown that combinational therapy of ML with continuous observation of liverkidney profiles and QTc prolongation can provide robust recovery with suppression of cytokines

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None