Tocilizumab in COVID-19 Lahore General Hospital (TC19LGH)
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|ClinicalTrials.gov Identifier: NCT04560205|
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : December 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV Infection||Drug: Tocilizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||quasi-experimental|
|Masking:||None (Open Label)|
|Official Title:||Tocilizumab: A Therapeutic Cache Against the Treatment of Severe Cases of COVID-19|
|Actual Study Start Date :||May 1, 2020|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
Experimental: Group intervene with Tocilizumab
Review effect of Tocilizumab as clinical trial among hospitalized patients with COVID-19 infection.
Participants with severe disease will receive an intravenous (IV) injection of 8 mg/kg (not to exceed 800 mg) tocilizumab. Specifically, we will test whether tocilizumab is associated with a reduction in multi-organ dysfunction among hospitalized COVID-19 adult patients with elevated inflammatory biomarkers.
4-8mg/kg with 400mg maximum dose of Tocilizumab will be given in 60 minutes I/V infusion, and dose will be repeated after 12-24 hours according to clinical as well as laboratory parameters.
Customized decision for Tocilizumab usage will be made by attending infectious diseases physician, comfort with Tocilizumab usage, bacterial co-infection and duration of Ventilation.
Other Name: ACTEMRA®
- Clinical response after administration [ Time Frame: 10 days ]Clinical improvement of COVID-19 patients by Tocillzumab The number of intubated patients. The number of patients with death.
- Clinical response to treatment [ Time Frame: 15 days ]Overall survival of COVID-19 patients after drug administration.
- Duration of hospitalization [ Time Frame: 15 days ]Number of days of hospital admission either in ICU or HDUs till date of discharge
- Clinical outcome of the treatment [ Time Frame: 15 days ]Mortality rate
- Supplemental Oxygen Requirement from Baseline [ Time Frame: 15 days ]Duration of increased supplemental oxygen requirement from baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04560205
|Contact: Muhammad Irfan Malikfirstname.lastname@example.org|
|Lahore General Hospital||Recruiting|
|Lahore, Punjab, Pakistan, 54500|
|Contact: Muhammad Irfan malik 03334367220 email@example.com|
|Study Director:||Sardar Al-Fareed Zafar||Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan|