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

Primary Purpose

Corona Virus Disease 2019 (COVID-19)

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Tocilizumab
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Corona Virus Disease 2019 (COVID-19) focused on measuring corona virus disease 2019 (COVID-19), Tocilizumab, Remdesivir, Interleukin receptor-6, glycoprotein-130, receptor blocker

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Lahore

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Active Comparator

Arm Label

Control

Tocilizumab

Remdesivir

Standard Treatment

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hospital stay
Oxygen demand
Viral load
by RT-PCR

Full Information

First Posted
December 19, 2020
Last Updated
December 30, 2020
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT04690920
Brief Title
Theranostic Implication of Complementary Medicines Against Interleukin Receptors and Gp-130 Proteins
Official Title
Theranostic Implication of Complimentary Medicines Against IL-6/Gp-130 in COVID-19.: An in Vitro and in Silco Approach
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 23, 2020 (Actual)
Primary Completion Date
December 10, 2020 (Actual)
Study Completion Date
December 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corona Virus Disease 2019 (COVID-19)
Keywords
corona virus disease 2019 (COVID-19), Tocilizumab, Remdesivir, Interleukin receptor-6, glycoprotein-130, receptor blocker

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Tocilizumab
Arm Type
Experimental
Arm Title
Remdesivir
Arm Type
Experimental
Arm Title
Standard Treatment
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Other Intervention Name(s)
Remdesivir, Standard treatment with Antibiotic, oxygen, Vitamin C, Statins, No treatment is given to control group
Intervention Description
Comparison of drugs, Tocilizumab, Remdesivir, standard treatment with controls
Primary Outcome Measure Information:
Title
Ratio of partial pressure of oxygen in arterial blood to fraction of inhaled oxygen
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Hospital stay
Time Frame
15 days
Title
Oxygen demand
Time Frame
7-15 days
Title
Viral load
Description
by RT-PCR
Time Frame
7-15 days

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Male and female diagnosed as COVID-19 infected by polymerase chain reaction (PCR)
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arif Malik, PhD
Organizational Affiliation
The University of Lahore
Official's Role
Study Director
Facility Information:
Facility Name
The University of Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
statistical analysis, results

Learn more about this trial

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

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