RC19LGH: Remdesivir in COVID-19 Lahore General Hospital

Sponsor
Lahore General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04560231
Collaborator
(none)
30
1
1
6
5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Qausi-experimentalQausi-experimental
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Is Remdesivir a Possible Therapeutic Option for SARS-CoV-2 : An Interventional Study
Actual Study Start Date :
Jun 1, 2020
Anticipated Primary Completion Date :
Nov 30, 2020
Anticipated Study Completion Date :
Nov 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group intervene with Remdesivir

Review effect of Remdesivir as clinical trial among hospitalized patients with COVID-19 infection. 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.

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.
Other Names:
  • Remidia
  • Outcome Measures

    Primary Outcome Measures

    1. Clinical response after administration [10 days]

      Clinical improvement of COVID-19 patients by Remdesivir.

    Secondary Outcome Measures

    1. Clinical response to treatment [15 days]

      Overall survival of COVID-19 patients after drug administration.

    2. Duration of hospitalization [15 days]

      Number of days of hospital admission either in ICU or HDUs till date of discharge

    3. Supplemental Oxygen Requirement from Baseline [15 days]

      Duration of increased supplemental oxygen requirement from baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients of all ages, males, and females who will be diagnosed COVID-19 positive by RT-PCR with moderate illness.

    • Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT chest.

    • Respiratory rate > 22/ min and >50% of radiological involvement of lung with typical lesions.

    • FiO2 remain static or improving along with > 30% deranged ≥ 2 biochemical markers CRP

    20 mg/l, LDH > 600 U/L, D.Dimer > 0.5mg/l or 500 ng/ml, Serum Ferritin < 500 ng/ml or mcg/l will be included in clinical trial.

    Exclusion Criteria:
    • Patients on Invasive mechanical ventilation (IMV).

    • Patients with respiratory rate < 20/mins and whose laboratory findings will not be deranged > 20%.

    • Presences of chronic renal failure > 4 stage, GFR < 30ml/min/1.73m2.

    • ALT/AST > 5 times than normal values.

    • Pregnant women.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Muhammad Irfan Malik Lahore Punjab Pakistan 54500

    Sponsors and Collaborators

    • Lahore General Hospital

    Investigators

    • Study Director: Muhammad Irfan Malik, FCPS, Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr. M.Irfan Malik, Associate Professor of Pulmonology / Focal Person COVID-19, Lahore General Hospital
    ClinicalTrials.gov Identifier:
    NCT04560231
    Other Study ID Numbers:
    • LGH003
    First Posted:
    Sep 23, 2020
    Last Update Posted:
    Sep 25, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr. M.Irfan Malik, Associate Professor of Pulmonology / Focal Person COVID-19, Lahore General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 25, 2020