Theranostic Implication of Complementary Medicines Against Interleukin Receptors and Gp-130 Proteins

Theranostic Implication of Complimentary Medicines Against IL-6/Gp-130 in COVID-19.: An in Vitro and in Silco Approach

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

Study Overview

• Status: Completed
• Conditions: Corona Virus Disease 2019 (COVID-19)
• Intervention / Treatment: Drug: Tocilizumab

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • The University of Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Tocilizumab	Drug: Tocilizumab; Comparison of drugs, Tocilizumab, Remdesivir, standard treatment with controls; Other Names: Remdesivir; Standard treatment with Antibiotic, oxygen, Vitamin C, Statins; No treatment is given to control group
Experimental: Remdesivir	Drug: Tocilizumab; Comparison of drugs, Tocilizumab, Remdesivir, standard treatment with controls; Other Names: Remdesivir; Standard treatment with Antibiotic, oxygen, Vitamin C, Statins; No treatment is given to control group
Active Comparator: Standard Treatment	Drug: Tocilizumab; Comparison of drugs, Tocilizumab, Remdesivir, standard treatment with controls; Other Names: Remdesivir; Standard treatment with Antibiotic, oxygen, Vitamin C, Statins; No treatment is given to control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ratio of partial pressure of oxygen in arterial blood to fraction of inhaled oxygen	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital stay		15 days
Oxygen demand		7-15 days
Viral load	by RT-PCR	7-15 days

Collaborators and Investigators

• Sponsor: University of Lahore
• Investigators: Study Director: Arif Malik, PhD, The University of Lahore

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2020
• Primary Completion (Actual): December 10, 2020
• Study Completion (Actual): December 10, 2020

Study Registration Dates

• First Submitted: December 19, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Tocilizumab; Remdesivir; corona virus disease 2019 (COVID-19); Interleukin receptor-6, glycoprotein-130; receptor blocker
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections; Virus Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Anti-Bacterial Agents; Remdesivir
• Other Study ID Numbers: UOL/IMBB/2020/118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: statistical analysis, results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No