MERS-CoV Infection tReated With A Combination of Lopinavir /Ritonavir and Interferon Beta-1b (NCT02845843) | Clinical Trial Compass
CompletedPhase 2/3
MERS-CoV Infection tReated With A Combination of Lopinavir /Ritonavir and Interferon Beta-1b
Saudi Arabia95 participantsStarted 2016-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult (defined as ≥18 years of age);
✓. Laboratory confirmation of MERS-CoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source; and
✓. 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
✕. Suicidal ideation based on history (contraindication to interferon (IFN)-β1b);
✕. 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;
✕. Elevated alanine aminotransferase (ALT) \>5 fold the upper limit in the hospital's laboratory;
✕. Use of medications that are contraindicated with lopinavir/ritonavir and that cannot be replaced or stopped during the study period, such as CYP3A inhibitors;
✕. Pregnancy - eligible and consenting female participants in childbearing age will be tested for pregnancy before enrollment in the study;
What they're measuring
1
90-day mortality
Timeframe: 90-day
Trial details
NCT IDNCT02845843
SponsorKing Abdullah International Medical Research Center
. Known HIV infection, because of concerns about the development of resistance to lopinavir/ritonavir if used without combination with other anti-HIV drugs; or
✕. Patient likely to be transferred to a non-participating hospital within 72 hours.