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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04560231
Other study ID # LGH003
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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