A Multi-centre, Double-blinded, Randomized, Placebo-controlled Trial on the Efficacy and Safety of Lopinavir / Ritonavir Plus Ribavirin in the Treatment of Severe Acute Respiratory Syndrome

Overview

The study aims to examine whether the combination of Lopinavir/Ritonavir plus Ribavirin for treatment of severe acute respiratory syndrome (SARS) is superior to placebo.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double

Interventions

  • Drug: Lopinavir / Ritonavir plus Ribavirin

Clinical Trial Outcome Measures

Primary Measures

  • Development of severe SARS
    • Time Frame: Any time during the acute illness

Secondary Measures

  • Adverse events
    • Time Frame: Throughout the illness period
  • SARS-CoV Viral load
    • Time Frame: Throughout the illness period
  • Immunological profile
    • Time Frame: Throughout the illness period

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female over the age of 18 with a diagnosis of SARS and with valid consent will be recruited. Exclusion Criteria:

  • Subjects with medical conditions that makes the prescription of study medications unsafe are excluded.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Hospital Authority, Hong Kong
  • Overall Official(s)
    • Wai Cho Yu, Dr, Principal Investigator, Department of Medicine & Geriatrics, Princess Margaret Hospital
  • Overall Contact(s)
    • Wai Cho Yu, Dr, (852) 2990 3737, yuwc@ha.org.hk

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