This is a placebo-controlled clinical trial to assess the efficacy and safety of a combination of lopinavir/ritonavir and Interferon beta-1b in hospitalized patients with MERS.
The aim of this study is to investigate the efficacy and safety of lopinavir /ritonavir and recombinant Interferon beta-1b combination given with optimal supportive care compared to placebo with optimal supportive care for patients with laboratory-confirmed MERS-CoV infection requiring hospital admission.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
95
Lopinavir /Ritonavir 400mg +100 mg / ml twice daily for 14 days and Interferon beta-1b 0.25 mg subcutaneous every alternate day for 14 days
Same characteristics as Lopinavir /Ritonavir and Interferon beta-1b to maintain blinding
Intensive Care Unit, King Abdulaziz Medical City, National Guard Health Affairs
Riyadh, Saudi Arabia
King Abdullah International Medical Research Center
Riyadh, Saudi Arabia
90-day mortality
Time frame: 90-day
Organ support-free days (e.g., supplemental O2, ventilator, extracorporeal membrane oxygenation (ECMO), renal replacement and vasopressors)
Time frame: 28 days
RT-PCR cycle threshold value in the lower respiratory samples
Time frame: At randomization and every 3 days afterwards, until 2 consecutive samples are negative or reaching a maximum of 90 days
Sequential organ failure assessment (SOFA) scores
Time frame: Days 0, 3, 7, 14, 21 and 28
ICU-free days
Time frame: Number of days in which patients are not being cared for in the ICU during the first 28 days after enrollment
Length of stay in hospital
Time frame: Up to one year from enrollment
Number of Patients with Adverse drug reactions related to the treatment
Time frame: From enrollment to 28 day
Karnofsky Performance Scale
Time frame: 90-day
ICU mortality
Time frame: Up to one year from enrollment
Hospital mortality
Time frame: Up to one year from enrollment
28-day mortality
Time frame: 28-day
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