Remdesivir in COVID-19 Lahore General Hospital

SARS-CoV Infection Clinical Trial

— RC19LGH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04560231
• Other study ID #: LGH003
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 1, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: September 2020
• Source: Lahore General Hospital
• Contact: Muhammad Irfan Malik, FCPS
• Phone: 03334367220
• Email: drmirfanmalik[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infections
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Muhammad Irfan Malik	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Lahore General Hospital

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Davies M, Osborne V, Lane S, Roy D, Dhanda S, Evans A, Shakir S. Remdesivir in Treatment of COVID-19: A Systematic Benefit-Risk Assessment. Drug Saf. 2020 Jul;43(7):645-656. doi: 10.1007/s40264-020-00952-1. — View Citation

Li Z, Wang X, Cao D, Sun R, Li C, Li G. Rapid review for the anti-coronavirus effect of remdesivir. Drug Discov Ther. 2020;14(2):73-76. doi: 10.5582/ddt.2020.01015. Review. — View Citation

Wang Y, Zhang D, Du G, Du R, Zhao J, Jin Y, Fu S, Gao L, Cheng Z, Lu Q, Hu Y, Luo G, Wang K, Lu Y, Li H, Wang S, Ruan S, Yang C, Mei C, Wang Y, Ding D, Wu F, Tang X, Ye X, Ye Y, Liu B, Yang J, Yin W, Wang A, Fan G, Zhou F, Liu Z, Gu X, Xu J, Shang L, Zhang Y, Cao L, Guo T, Wan Y, Qin H, Jiang Y, Jaki T, Hayden FG, Horby PW, Cao B, Wang C. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2020 May 16;395(10236):1569-1578. doi: 10.1016/S0140-6736(20)31022-9. Epub 2020 Apr 29. Erratum in: Lancet. 2020 May 30;395(10238):1694. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response after administration	Clinical improvement of COVID-19 patients by Remdesivir.	10 days
Secondary	Clinical response to treatment	Overall survival of COVID-19 patients after drug administration.	15 days
Secondary	Duration of hospitalization	Number of days of hospital admission either in ICU or HDUs till date of discharge	15 days
Secondary	Supplemental Oxygen Requirement from Baseline	Duration of increased supplemental oxygen requirement from baseline	15 days