MERS-CoV Infection tReated With A Combination of Lopinavir /Ritonavir and Interferon Beta-1b

Phase 2

Completed

• Conditions: Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
• Interventions: Drug: Combination of Lopinavir /Ritonavir and Interferon beta-1b; Drug: Placebo

• Registration Number: NCT02845843
• Lead Sponsor: King Abdullah International Medical Research Center

Brief 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.

Study Timeline

• Study First Submitted: 2016-06-20
• Study Start: 2016-07
• Study First Submitted QC: 2016-07-23
• Study First Posted: 2016-07-27
• Status Verified: 2020-05
• Primary Completion: 2020-05
• Study Completion: 2020-05
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination of Lopinavir /Ritonavir and IntErferon Beta 1B	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
Placebo	Placebo	Same characteristics as Lopinavir /Ritonavir and Interferon beta-1b to maintain blinding

Primary Outcome Measures

Name	Time	Method
90-day mortality	90-day

Secondary Outcome Measures

Name	Time	Method
28-day mortality	28-day
Sequential organ failure assessment (SOFA) scores	Days 0, 3, 7, 14, 21 and 28
ICU-free days	Number of days in which patients are not being cared for in the ICU during the first 28 days after enrollment
ICU mortality	Up to one year from enrollment
Hospital mortality	Up to one year from enrollment
RT-PCR cycle threshold value in the lower respiratory samples	At randomization and every 3 days afterwards, until 2 consecutive samples are negative or reaching a maximum of 90 days
Organ support-free days (e.g., supplemental O2, ventilator, extracorporeal membrane oxygenation (ECMO), renal replacement and vasopressors)	28 days
Length of stay in hospital	Up to one year from enrollment
Number of Patients with Adverse drug reactions related to the treatment	From enrollment to 28 day
Karnofsky Performance Scale	90-day

Trial Locations

Locations (2)

Intensive Care Unit, King Abdulaziz Medical City, National Guard Health Affairs; 🇸🇦 Riyadh, Saudi Arabia

King Abdullah International Medical Research Center; 🇸🇦 Riyadh, Saudi Arabia