Effectiveness of Remedesvir in COVID-19 Patients Presenting at Mayo Hospital Lahore
Primary Purpose
COVID-19
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Remdesivir
Conventional
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Remdesvir, Sars CoV-2, Effectiveness
Eligibility Criteria
Inclusion Criteria:
- All Patients with confirmed COVID-19 of either gender and aged 12 years and above.
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:
- Known severe allergic reaction to Remdesivir or to other antiviral drugs
- Patients already having other treatments like tocilizumab or other antiviral drugs
- Pregnancy or breastfeeding
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times upper normal limit
- Creatinine clearance <30ml/min
- Low platelet count <50,000/l
Sites / Locations
- Mayo Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Remdesivir
Conventional
Arm Description
patients having drug Remdesivir in addition to conventional treatment according to disease grade (steroids, anticoagulants, antibiotics if needed, oxygen therapy, paracetamol, antihistamine)
patients having Standard Conventional therapy only.
Outcomes
Primary Outcome Measures
Hospital Stay
Duration of stay in hospital in days
Ventilation
No of patients needing IPPV
Secondary Outcome Measures
Full Information
NCT ID
NCT04871633
First Posted
January 11, 2021
Last Updated
May 2, 2021
Sponsor
King Edward Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04871633
Brief Title
Effectiveness of Remedesvir in COVID-19 Patients Presenting at Mayo Hospital Lahore
Official Title
Effectiveness of Remedesvir in SARS-CoV2 Patients Presenting at Mayo Hospital Lahore
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
November 15, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Edward Medical University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Remdesvir, Sars CoV-2, Effectiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remdesivir
Arm Type
Active Comparator
Arm Description
patients having drug Remdesivir in addition to conventional treatment according to disease grade (steroids, anticoagulants, antibiotics if needed, oxygen therapy, paracetamol, antihistamine)
Arm Title
Conventional
Arm Type
Other
Arm Description
patients having Standard Conventional therapy only.
Intervention Type
Drug
Intervention Name(s)
Remdesivir
Other Intervention Name(s)
Veklury
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Conventional
Other Intervention Name(s)
Solumedrol, dexamethasone,prednisolone, azithromycin
Intervention Description
IV Steroids Antibiotics
Primary Outcome Measure Information:
Title
Hospital Stay
Description
Duration of stay in hospital in days
Time Frame
10 days
Title
Ventilation
Description
No of patients needing IPPV
Time Frame
10 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All Patients with confirmed COVID-19 of either gender and aged 12 years and above.
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:
Known severe allergic reaction to Remdesivir or to other antiviral drugs
Patients already having other treatments like tocilizumab or other antiviral drugs
Pregnancy or breastfeeding
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times upper normal limit
Creatinine clearance <30ml/min
Low platelet count <50,000/l
Facility Information:
Facility Name
Mayo Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Remedesvir in COVID-19 Patients Presenting at Mayo Hospital Lahore
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