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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group intervene with Remdesivir | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remdesivir | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response after administration | Clinical improvement of COVID-19 patients by Remdesivir. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response to treatment | Overall survival of COVID-19 patients after drug administration. | 15 days |
| Duration of hospitalization | Number of days of hospital admission either in ICU or HDUs till date of discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Irfan Malik, FCPS | Contact | 03334367220 | drmirfanmalik@hotmail.com | |
| Sardar Al-Fareed Zafar, FCPS | Contact | 03214056891 | alfareedivf@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Muhammad Irfan Malik, FCPS | Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muhammad Irfan Malik | Recruiting | Lahore | Punjab Province | 54500 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32423584 | Background | 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. | |
| 32468196 |
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| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
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| ID | Term |
|---|---|
| C000606551 | remdesivir |
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Qausi-experimental
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|
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| 15 days |
| Supplemental Oxygen Requirement from Baseline | Duration of increased supplemental oxygen requirement from baseline | 15 days |
| Background |
| 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. |
| 32378648 | Background | 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. |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |