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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04690920
Other study ID # UOL/IMBB/2020/118
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 23, 2020
Est. completion date December 10, 2020

Study information

Verified date December 2020
Source University of Lahore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 10, 2020
Est. primary completion date December 10, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Pakistan The University of Lahore Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ratio of partial pressure of oxygen in arterial blood to fraction of inhaled oxygen 7 days
Secondary Hospital stay 15 days
Secondary Oxygen demand 7-15 days
Secondary Viral load by RT-PCR 7-15 days