ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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

Locations
China
Department of Health Not yet recruiting
Hong Kong, China
Sub-Investigator: Wilina Lim, Dr         
Kowloon Hospital Not yet recruiting
Hong Kong, China
Sub-Investigator: Thomas Mok, Dr         
Prince of Wales Hospital Not yet recruiting
Hong Kong, China
Princess Margaret Hospital Not yet recruiting
Hong Kong, China
Sub-Investigator: ST Lai, Dr         
Sub-Investigator: KL Au, Dr         
Queen Mary Hospital Not yet recruiting
Hong Kong, China
The Chinese University of Hong Kong Not yet recruiting
Hong Kong, China
Sub-Investigator: Dennis Lo, Prof         
Sub-Investigator: Christopher Lam, Prof         
Sub-Investigator: David Hui, Prof         
The University of Hong Kong Not yet recruiting
Hong Kong, China
Sub-Investigator: Malik Peiris, Prof         
Sub-Investigator: Kenneth Tsang, Prof         
Sub-Investigator: KY Yuen, Prof         
Tuen Mun Hospital Not yet recruiting
Hong Kong, China
United Christian Hospital Not yet recruiting
Hong Kong, China
Sponsors and Collaborators
Hospital Authority, Hong Kong
Investigators
Principal Investigator: Wai Cho Yu, Dr Department of Medicine & Geriatrics, Princess Margaret Hospital
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
HAREC Clinical Trial Registry  This link exits the ClinicalTrials.gov site

ClinicalTrials.gov Identifier: NCT00578825     History of Changes
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:
Syndrome
Severe Acute Respiratory Syndrome
Coronavirus Infections
Disease
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Ribavirin
Ritonavir
 Lopinavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors