MERS-CoV Infection tReated With A Combination of Lopinavir /Ritonavir and Interferon Beta-1b
MERS-CoV Infection tReated With A Combination of Lopinavir /Ritonavir and Interferon Beta-1b
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.
Inclusion criteria at eligibility assessment

 1. Adult (defined as ≥18 years of age);

 2. Laboratory confirmation of MERS-CoV infection by reverse-transcription polymerase
 chain reaction (RT-PCR) from any diagnostic sampling source; and

 3. New organ dysfunction that is judged to related to MERS including: hypoxia defined as
 requirement of supplemental oxygen to maintain oxygen saturations >90%, hypotension
 (systolic blood pressure<90 mmHg) or need for vasopressor/inotropic medication, renal
 impairment (increase of creatinine by 50% from baseline, glomerular filtration rate
 reduction by >25% from baseline or urine output of <0.5 ml/kg for 6 hours - Risk stage
 by RIFLE criteria), neurologic (reduction of Glasgow Coma Scale by 2 or more, i.e. 13
 or lower of 15 points), thrombocytopenia (<150,000 platelets/mm3) or gastrointestinal
 symptoms that requires hospitalization (e.g. severe nausea, vomiting, diarrhea or/and
 abdominal pain).

 Exclusion criteria at eligibility assessment

 1. Suicidal ideation based on history (contraindication to interferon (IFN)-β1b);

 2. Known allergy or hypersensitivity reaction to lopinavir/ritonavir or to recombinant
 IFN-β1b, including, but not limited to, toxic epidermal necrolysis, Stevens-Johnson
 syndrome, erythema multiforme, urticaria or angioedema;

 3. Elevated alanine aminotransferase (ALT) >5 fold the upper limit in the hospital's
 laboratory;

 4. Use of medications that are contraindicated with lopinavir/ritonavir and that cannot
 be replaced or stopped during the study period, such as CYP3A inhibitors;

 5. Pregnancy - eligible and consenting female participants in childbearing age will be
 tested for pregnancy before enrollment in the study;

 6. Known HIV infection, because of concerns about the development of resistance to
 lopinavir/ritonavir if used without combination with other anti-HIV drugs; or

 7. Patient likely to be transferred to a non-participating hospital within 72 hours.