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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

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ClinicalTrials.gov Identifier: NCT00578825
Recruitment Status : Unknown
Verified August 2013 by Hospital Authority, Hong Kong.
Recruitment status was:  Not yet recruiting
First Posted : December 21, 2007
Last Update Posted : August 22, 2013
Sponsor:
Information provided by:
Hospital Authority, Hong Kong

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Severe Acute Respiratory Syndrome Drug: Lopinavir / Ritonavir plus Ribavirin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Development of severe SARS [ Time Frame: Any time during the acute illness ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Throughout the illness period ]
  2. SARS-CoV Viral load [ Time Frame: Throughout the illness period ]
  3. Immunological profile [ Time Frame: Throughout the illness period ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578825


Contacts
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Contact: Wai Cho Yu, Dr (852) 2990 3737 yuwc@ha.org.hk

Locations
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China
Department of Health
Hong Kong, China
Sub-Investigator: Wilina Lim, Dr         
Kowloon Hospital
Hong Kong, China
Sub-Investigator: Thomas Mok, Dr         
Prince of Wales Hospital
Hong Kong, China
Princess Margaret Hospital
Hong Kong, China
Sub-Investigator: ST Lai, Dr         
Sub-Investigator: KL Au, Dr         
Queen Mary Hospital
Hong Kong, China
The Chinese University of Hong Kong
Hong Kong, China
Sub-Investigator: Dennis Lo, Prof         
Sub-Investigator: Christopher Lam, Prof         
Sub-Investigator: David Hui, Prof         
The University of Hong Kong
Hong Kong, China
Sub-Investigator: Malik Peiris, Prof         
Sub-Investigator: Kenneth Tsang, Prof         
Sub-Investigator: KY Yuen, Prof         
Tuen Mun Hospital
Hong Kong, China
United Christian Hospital
Hong Kong, China
Sponsors and Collaborators
Hospital Authority, Hong Kong
Investigators
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Principal Investigator: Wai Cho Yu, Dr Department of Medicine & Geriatrics, Princess Margaret Hospital
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00578825    
Other Study ID Numbers: KW/FR/04-009
HARECCTR0500028
NTWC/CREC/349/05
First Posted: December 21, 2007    Key Record Dates
Last Update Posted: August 22, 2013
Last Verified: August 2013
Keywords provided by Hospital Authority, Hong Kong:
Severe acute respiratory syndrome
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Syndrome
Disease
Pathologic Processes
Respiratory Tract Infections
Infections
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Ritonavir
Lopinavir
 Ribavirin
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antimetabolites