NCT04690920

Brief Summary

IL-6 is an inflammatory marker, secrete by the cells in many pathological conditions like COVID-19 pneumonia. Interleukin 6 bind with its receptors (IL-6R) on cells surface and recruited a protein for its activation known as gp-130. Activated receptors send signals to nucleus through secondary messenger system and up regulate the expression of IL-6/GP130 domain. Total of two hundred (n=200) participants were included in the current study and divided equally in four groups. Group B is given Tocilizumab and Group C is treated with Remdesivir along with the approved standard treatment. Group D is only Given standard therapy and Group A constituted normal healthy age and sexed matched participants. Levels of gp-130 were estimated by commercially available ELISA kit. To estimate the relationship of severity of disease with gp-130 and IL-6 Pearson's correlations was used. Sensitivity and specificity for what purpose

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 23, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
Last Updated

December 31, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

December 19, 2020

Last Update Submit

December 30, 2020

Conditions

Keywords

corona virus disease 2019 (COVID-19)TocilizumabRemdesivirInterleukin receptor-6, glycoprotein-130receptor blocker

Outcome Measures

Primary Outcomes (1)

  • Ratio of partial pressure of oxygen in arterial blood to fraction of inhaled oxygen

    7 days

Secondary Outcomes (3)

  • Hospital stay

    15 days

  • Oxygen demand

    7-15 days

  • Viral load

    7-15 days

Study Arms (4)

Control

NO INTERVENTION

Tocilizumab

EXPERIMENTAL
Drug: Tocilizumab

Remdesivir

EXPERIMENTAL
Drug: Tocilizumab

Standard Treatment

ACTIVE COMPARATOR
Drug: Tocilizumab

Interventions

Comparison of drugs, Tocilizumab, Remdesivir, standard treatment with controls

Also known as: Remdesivir, Standard treatment with Antibiotic, oxygen, Vitamin C, Statins, No treatment is given to control group
RemdesivirStandard TreatmentTocilizumab

Eligibility Criteria

Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale and female diagnosed as COVID-19 infected by polymerase chain reaction (PCR)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted diagnosed cases of COVID-19 infection on real time polymerase chain reaction (RT-PCR) Both male and female were included All participants were on oxygen therapy

You may not qualify if:

  • Asthmatics pulmonary fibrosis chronic obstructive pulmonary disease (COPD) Allergic to remdesivir Allergic to Actemra Refused to take consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

COVID-19

Interventions

tocilizumabremdesivirAnti-Bacterial AgentsOxygenAscorbic AcidHydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesChalcogensElementsInorganic ChemicalsGasesSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesAnticholesteremic AgentsHypolipidemic AgentsAntimetabolitesMolecular Mechanisms of Pharmacological ActionEnzyme InhibitorsLipid Regulating Agents

Study Officials

  • Arif Malik, PhD

    University of Lahore

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 19, 2020

First Posted

December 31, 2020

Study Start

July 23, 2020

Primary Completion

December 10, 2020

Study Completion

December 10, 2020

Last Updated

December 31, 2020

Record last verified: 2020-12

Locations