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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04871633
Recruitment Status : Completed
First Posted : May 4, 2021
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
King Edward Medical University

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Remdesivir Drug: Conventional Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Remedesvir in SARS-CoV2 Patients Presenting at Mayo Hospital Lahore
Actual Study Start Date : August 1, 2020
Actual Primary Completion Date : November 15, 2020
Actual Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


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 Name: Veklury

Drug: Conventional
IV Steroids Antibiotics
Other Name: Solumedrol, dexamethasone,prednisolone, azithromycin

Conventional
patients having Standard Conventional therapy only.
Drug: Conventional
IV Steroids Antibiotics
Other Name: Solumedrol, dexamethasone,prednisolone, azithromycin




Primary Outcome Measures :
  1. Hospital Stay [ Time Frame: 10 days ]
    Duration of stay in hospital in days

  2. Ventilation [ Time Frame: 10 Days ]
    No of patients needing IPPV



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04871633


Locations
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Pakistan
Mayo Hospital
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
King Edward Medical University
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Responsible Party: King Edward Medical University
ClinicalTrials.gov Identifier: NCT04871633    
Other Study ID Numbers: 483/RC/KEMU
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by King Edward Medical University:
Remdesvir
Sars CoV-2
Effectiveness
Additional relevant MeSH terms:
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Azithromycin
Dexamethasone
Prednisolone
Methylprednisolone Hemisuccinate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Neuroprotective Agents
Protective Agents
Anti-Bacterial Agents
Anti-Infective Agents