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

NCT04871633 | Completed DMC

• 1 other identifier: 483/RC/KEMU
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Remdesvir; Sars CoV-2; Effectiveness

Outcome Measures

Primary Outcomes (2)

• Hospital Stay

  Duration of stay in hospital in days

  10 days

• Ventilation

  No of patients needing IPPV

  10 Days

Study Arms (2)

Remdesivir

ACTIVE COMPARATOR

patients having drug Remdesivir in addition to conventional treatment according to disease grade (steroids, anticoagulants, antibiotics if needed, oxygen therapy, paracetamol, antihistamine)

Drug: Remdesivir; Drug: Conventional

Conventional

OTHER

patients having Standard Conventional therapy only.

Drug: Conventional

Interventions

Remdesivir DRUG

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

Also known as: Veklury

Remdesivir

Conventional DRUG

IV Steroids Antibiotics

Also known as: Solumedrol, dexamethasone,prednisolone, azithromycin

Conventional; Remdesivir

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

COVID-19

Interventions

remdesivir; Congresses as Topic; Methylprednisolone Hemisuccinate; Dexamethasone; Prednisolone; Azithromycin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations; Methylprednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: May 4, 2021
• Study Start: August 1, 2020
• Primary Completion: November 15, 2020
• Study Completion: December 30, 2020
• Last Updated: May 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)