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Remdesivir in COVID-19 Lahore General Hospital (RC19LGH)

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: NCT04560231
Recruitment Status : Unknown
Verified September 2020 by Dr. M.Irfan Malik, Lahore General Hospital.
Recruitment status was:  Recruiting
First Posted : September 23, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. M.Irfan Malik, Lahore General Hospital

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
SARS-CoV Infection Drug: Remdesivir 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Qausi-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 : June 1, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020


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 Name: Remidia




Primary Outcome Measures :
  1. Clinical response after administration [ Time Frame: 10 days ]
    Clinical improvement of COVID-19 patients by Remdesivir.


Secondary Outcome Measures :
  1. Clinical response to treatment [ Time Frame: 15 days ]
    Overall survival of COVID-19 patients after drug administration.

  2. Duration of hospitalization [ Time Frame: 15 days ]
    Number of days of hospital admission either in ICU or HDUs till date of discharge

  3. Supplemental Oxygen Requirement from Baseline [ Time Frame: 15 days ]
    Duration of increased supplemental oxygen requirement from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT04560231


Contacts
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Contact: Muhammad Irfan Malik, FCPS 03334367220 drmirfanmalik@hotmail.com
Contact: Sardar Al-Fareed Zafar, FCPS 03214056891 alfareedivf@hotmail.com

Locations
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Pakistan
Muhammad Irfan Malik Recruiting
Lahore, Punjab, Pakistan, 54500
Contact: Muhammad Irfan Malik, FCPS    03334367220    drmirfanmalik@hotmail.com   
Contact: Sardar Al-Fareed Zafar, FCPS    03214056891    alfareedivf@hotmail.com   
Sponsors and Collaborators
Lahore General Hospital
Investigators
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Study Director: Muhammad Irfan Malik, FCPS Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan
Publications:
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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: September 23, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
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
Keywords provided by Dr. M.Irfan Malik, Lahore General Hospital:
COVID-19
Remdesivir
Additional relevant MeSH terms:
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Remdesivir
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents