NCT04560231

Remdesivir in COVID-19 Lahore General Hospital

Is Remdesivir a Possible Therapeutic Option for SARS-CoV-2 : An Interventional Study

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Lahore General Hospital · Other Government
• Sex: All
• Age: 15 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Remdesivir is a monophosphoramidate prodrug of an adenosine analogue and it has a broad-spectrum antiviral activity against paramyxoviruses, falviviruses and coronaviruses. It showed in vitro activity on human airway epithelial cells against SARS-CoV-2. It is an investigational drug and granted an Emergency Use Authorization by Food and Drug Administration FDA, so it is under clinical trial. The potent mechanism of action of this drug is still unclear but it effects through several processes. It can interfere with nsp12 polymerase even when exoribonuclease proofreading is intact. It can also produce nucleoside triphosphate NTP that acts pharmacologically active alternate substrate of RNA-chain terminator, as a result NTP can constrain active triphosphates into viral RNA of coronaviruses. There is evidence of high genetic barrier to develop resistance against Remdesivir in coronavirus as a result of which is maintains its effectiveness in antiviral therapies against these viruses. Effectiveness of Remdesivir has been reported against different groups of coronaviruses including Alphacoronavirus NL63 and several SARS/MERS-CoV coronaviruses.

Detailed description

This is interventional single-center study, that will be done at Lahore General Hospital in which 95 beds are allocated for COVID-19 patients including ICUs and HDUs. Ethical approval will be obtained from research ethical committee of Lahore General hospital, Lahore. Informed consent will be obtained from all patients who will agree to publish their data in this research. Patient's privacy protection will be obeyed with the Helsinki Declaration. The aim of this study is to evaluate clinical effectiveness of this investigational drug, started a clinical trial of this drug on laboratory-confirmed COVID-19 patients at a tertiary care hospital of Lahore, Pakistan.

Conditions

• SARS-CoV Infection

Interventions

Type	Name	Description
DRUG	Remdesivir	200 mg I/v Remdesivir will be given to moderate disease patients of COVID-19. It will be loading dose then 100 mg I/V dose will be given for 5 days. Customized decision for Remdesivir dosage will be made by attending infectious diseases physician, comfort with usage, bacterial co-infection and duration of Ventilation and dose will be extended up to 10 days according to clinical condition of the patients.

Timeline

• Start date: 2020-06-01
• Primary completion: 2020-11-30
• Completion: 2020-11-30
• First posted: 2020-09-23
• Last updated: 2020-09-25

Locations

1 site across 1 country: Pakistan