NCT02845843

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: a Multicenter, Placebo-controlled, Double-blind Randomized Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: King Abdullah International Medical Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Middle East Respiratory Syndrome Coronavirus (MERS-CoV)

Interventions

Type	Name	Description
DRUG	Combination of Lopinavir /Ritonavir and Interferon beta-1b	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
DRUG	Placebo	Same characteristics as Lopinavir /Ritonavir and Interferon beta-1b to maintain blinding

Timeline

• Start date: 2016-07-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2016-07-27
• Last updated: 2020-05-20

Locations

2 sites across 1 country: Saudi Arabia