NCT04560231

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jun 2020

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

July 11, 2020

Last Update Submit

September 24, 2020

Conditions

SARS-CoV Infection

Keywords

COVID-19Remdesivir

Outcome Measures

Primary Outcomes (1)

  • Clinical response after administration

    Clinical improvement of COVID-19 patients by Remdesivir.

    10 days

Secondary Outcomes (3)

  • Clinical response to treatment

    15 days

  • Duration of hospitalization

    15 days

  • Supplemental Oxygen Requirement from Baseline

    15 days

Study Arms (1)

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.

Drug: Remdesivir

Interventions

RemdesivirDRUG

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.

Also known as: Remidia
Group intervene with Remdesivir

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhammad Irfan Malik

Lahore, Punjab Province, 54500, Pakistan

RECRUITING

Related Publications (3)

  • 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.

    PMID: 32423584BACKGROUND

  • 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.

    PMID: 32468196BACKGROUND

  • 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.

    PMID: 32378648BACKGROUND

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeCOVID-19

Interventions

remdesivir

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaLung Diseases

Study Officials

  • Muhammad Irfan Malik, FCPS

    Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan

    STUDY DIRECTOR

Central Study Contacts

Muhammad Irfan Malik, FCPS

CONTACT

03334367220drmirfanmalik@hotmail.com

Sardar Al-Fareed Zafar, FCPS

CONTACT

03214056891alfareedivf@hotmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Qausi-experimental
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pulmonology / Focal Person COVID-19

Study Record Dates

First Submitted

July 11, 2020

First Posted

September 23, 2020

Study Start

June 1, 2020

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

September 25, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)