Effectiveness of Remedesvir in COVID-19 Patients Presenting at Mayo Hospital Lahore

May 2, 2021 updated by: King Edward Medical University

Effectiveness of Remedesvir in SARS-CoV2 Patients Presenting at Mayo Hospital Lahore

Currently, several drugs including Remdesivir, hydroxychloroquine, chloroquine, ritonavir+lopinavir, Tocilizumab, Arbidol and interferon are under randomised controlled trials (RCTs) for efficacy and/or safety evaluations in patients with COVID-19 in different countries. Remdesivir (GS-5734) is among these investigational drugs and some studies reported promising results. Remdesivir is a nucleotide analogue intravenous pro-drug developed by Gilead Sciences, an American biopharmaceutical company, for treatment of Ebola virus during the 2014 Ebola outbreak in Western Africa. Remdesivir shows broad-spectrum antiviral activity against many RNA viruses including SARS-CoV-2 through blocking RNA polymerase thereby terminating RNA transcription. Remdesivir was among the first treatments used in China as the outbreak emerges and it has been reported as potential treatment options for COVID-19 in the USA, China and Italy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Coronavirus diseases 2019 (COVID-19) is caused by a novel β-coronavirus which is named as SARS-CoV-2. SARS-CoV-2 shares 79% RNA sequence identity with severe acute respiratory syndrome coronavirus 2 (SARS-COV2) and 50% genomic sequence identity with Middle East respiratory syndrome coronavirus (MERS-CoV) which caused a major outbreak since 2002 and 2012 in China and Saudi Arabia, respectively. Despite global containment measures to fight the disease, the pandemic continued to rise, rapidly spread across the world, and resulting in in 10.5 million confirmed cases and 51391 deaths worldwide as of July 1st 2020. The outbreak of COVID-19 infection has a significant threat to international health, the economy, psychological stress and mental health worldwide. Yet, there are no approved vaccines or drugs to make the disease less deadly; implying that searching therapeutic options are critical issues to overcome the outbreak. Studies are strongly underway to discover rapidly drug candidates for COVID-19, and studies are looking into repurposing drugs that have been used for the treatment of other diseases.

Pakistan is badly facing this pandemic too. Up till now there are 221,896 confirmed cases with 4551 deaths with a death ratio of 2.1%. More than 3000 patients are critical.8 In Punjab, being allocated as a leading tertiary care centre for COVID-19 patients, Mayo hospital Lahore is dealing with each and every category of COVID-19 patients with variable presentations and treating those patients with different investigational drugs in keeping with other countries to find the best possible treatable drug.

US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) of the antiviral drug remdesivir for the treatment of patients with COVID-19. Although clinical trials have showed remdesivir as a treatment option for COVID-19, results are controversial. That's why we need to conduct a trial in our part of the world too to see its effectiveness in patients presenting with Covid-19.

Remdesivir has been recently approved by CEAG (Corona Expert Advisory Group) for COVID patient is Mayo hospital. Remdesivir has never been used before in any public sector hospital in Punjab. Investigators aim to do this study in Mayo hospital Lahore to check the efficiency of this drug in COVID-19 patients in Mayo hospital Lahore

OBJECTIVE:

The objective of the study is to evaluate the effectiveness of remdesivir in patients with COVID-19 presenting to Mayo Hospital Lahore

OUTCOME AND UTILIZATION:

To date, no therapy has demonstrated efficacy for patients with COVID-19.This study will help in finding any definite role of Remdesivir in COVID -19 patients who are severely ill . Although data from several international ongoing randomized, controlled trials will soon provide more informative evidence regarding the safety and efficacy of remdesivir for COVID-19, but this needs to be evaluated in local arena too.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Mayo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. All Patients with confirmed COVID-19 of either gender and aged 12 years and above.

  2. Patients having Severe COVID 19 Disease. Severe disease is defined as patients with an oxygen saturation (SpO2) ≤94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO).17

    -

Exclusion Criteria:

  1. Known severe allergic reaction to Remdesivir or to other antiviral drugs
  2. Patients already having other treatments like tocilizumab or other antiviral drugs
  3. Pregnancy or breastfeeding
  4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times upper normal limit
  5. Creatinine clearance <30ml/min
  6. Low platelet count <50,000/l

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Remdesivir
patients having drug Remdesivir in addition to conventional treatment according to disease grade (steroids, anticoagulants, antibiotics if needed, oxygen therapy, paracetamol, antihistamine)
Drug: Remdesivir
Remdesivir is an intravenous (IV) loading dose of 200 mg on day 1 followed by daily IV maintenance doses of 100 mg for 5-10 days
Other Names:
  • Veklury
Drug: Conventional
IV Steroids Antibiotics
Other Names:
  • Solumedrol, dexamethasone,prednisolone, azithromycin
OTHER: Conventional
patients having Standard Conventional therapy only.
Drug: Conventional
IV Steroids Antibiotics
Other Names:
  • Solumedrol, dexamethasone,prednisolone, azithromycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Stay
Time Frame: 10 days
Duration of stay in hospital in days
10 days
Ventilation
Time Frame: 10 Days
No of patients needing IPPV
10 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Edward Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2020

Primary Completion (ACTUAL)

November 15, 2020

Study Completion (ACTUAL)

December 30, 2020

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

May 2, 2021

First Posted (ACTUAL)

May 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2021

Last Update Submitted That Met QC Criteria

May 2, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 483/RC/KEMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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