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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04486521
Other study ID # RAC # 2201053
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 22, 2020
Est. completion date July 22, 2021

Study information

Verified date March 2021
Source King Faisal Specialist Hospital & Research Center
Contact Marwa Amer, PharmD,BCPS, BCCCP
Phone +966114647272
Email mamer@kfshrc.edu.sa
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The cytokine storms mediated by over production of proinflammatory cytokines have been observed in a large population of critically ill patients infected with COVID-19. Patients diagnosed with cytokine storms progress to cardiovascular collapse, multiple organ dysfunction and death rapidly. Therefore, early identification, treatment and prevention of the cytokine storms are of crucial importance for the patients. Immuomedulator such as interleukin-6 (IL-6) antagonist, emerged as an alternative treatment for COVID-19 patients with a risk of cytokine storms recently. In this study, we aimed to evaluate the safety and efficacy of anti-IL6 alone vs anti-IL6 corticosteroid combination in patients with COVID-19 pneumonia


Description:

This study will provide further insight whether anti-IL6 alone provide same efficacy and clinical outcome with reasonable side effects profile compared to anti-IL6 + corticosteroid and might serve as a corticosteroid sparing agents in COVID-19 patient with cytokine storms. Data elements will be retrieved from VIRUS registry which is a prospective, non-interventional, multi-center, multi-national observational cross sectional study


Recruitment information / eligibility

Status Recruiting
Enrollment 860
Est. completion date July 22, 2021
Est. primary completion date July 22, 2021
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility Inclusion Criteria: 1. Adult Critically ill patients 2. COVID-19 PCR positive 3. Presence of clinical and radiological signs of progressive disease, and laboratory evidence indicative of risk for cytokine storm complications. 4. Received anti-IL6 or corticosteroids as part of COVID-19 treatment Exclusion Criteria: 1. Non COVID-19 related admissions 2. Repeated Admission to ICUs/Hospital 3. Patient did not receive anti-IL6 or corticosteroids

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Interleukin 6 (IL6) Antagonist
anti-IL6 alone
Interleukin 6 (IL6) Antagonist and corticosteroids
anti-IL6 + corticosteroid combination
corticosteroid alone
dexamethasone, hydrocortisone, methylprednisolone, prednisone. All steroids " other than dexamethasone" will be converted to dexamethasone equivalent

Locations

Country Name City State
Saudi Arabia King Faisal Specialist Hospital and Research Center Riyadh

Sponsors (2)

Lead Sponsor Collaborator
King Faisal Specialist Hospital & Research Center Society of Critical Care Medicine

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (1)

Walkey AJ, Kumar VK, Harhay MO, Bolesta S, Bansal V, Gajic O, Kashyap R. The Viral Infection and Respiratory Illness Universal Study (VIRUS): An International Registry of Coronavirus 2019-Related Critical Illness. Crit Care Explor. 2020 Apr 29;2(4):e0113. doi: 10.1097/CCE.0000000000000113. eCollection 2020 Apr. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Ventilator-Free Days The median ventilator-free days will be calculated as calendar days with no ventilator support to day 28 . Participants who die before day 28 are assigned zero free days. Up to Day 28
Secondary Median duration of ventilation From Intubation to extubation date and off Mechanical Ventilation or until ICU discharge, death, or 28 days whichever occurs first. Up to Day 28
Secondary Median change in the PaO2/FiO2 Ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2) Up to Day 28
Secondary Vasopressor-Free days The median vasopressor-free days will be calculated as calendar days with no vasopressor support to day 28. Participants who die before day 28 are assigned zero free days. Up to Day 28
Secondary Duration of ICU Stay To compare ICU LOS Up to 28 days
Secondary Duration of Hospital Stay To compare hospital LOS Up to 28 days
Secondary Mortality Rate Death that occurs during 28 days Up to Day 28
Secondary Percentage of participants with adverse events [transaminitis, hyperglycemia] adverse events that occurs during 28 days Up to 28 days
Secondary Concentration of Ferritin, IL6, D dimer, fibrinogen, C-reactive protein (CRP), Lactate dehydrogenase (LDH) and absolute lymphocyte count and their correlation with the effectiveness of the treatment Concentration of inflammatory markers Up to 28 days
Secondary Rate of superinfection (bacterial, viral, invasive fungal infections) Up to 28 days
Secondary Time to the first COVID 19 test negative Up to 28 days
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