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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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Hospital Authority, Hong Kong
Sponsor:
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00578825
First received: December 20, 2007
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

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 Intervention
Severe Acute Respiratory Syndrome
Drug: Lopinavir / Ritonavir plus Ribavirin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 NLM:


Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:
  • Development of severe SARS [ Time Frame: Any time during the acute illness ]

Secondary Outcome 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 ]

Estimated Enrollment: 340
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578825

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

Locations
China
Princess Margaret Hospital Not yet recruiting
Hong Kong, China
Sub-Investigator: ST Lai, Dr         
Sub-Investigator: KL Au, Dr         
United Christian Hospital Not yet recruiting
Hong Kong, China
Prince of Wales Hospital Not yet recruiting
Hong Kong, China
Queen Mary Hospital Not yet recruiting
Hong Kong, China
Tuen Mun Hospital Not yet recruiting
Hong Kong, China
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         
Department of Health Not yet recruiting
Hong Kong, China
Sub-Investigator: Wilina Lim, Dr         
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         
Kowloon Hospital Not yet recruiting
Hong Kong, China
Sub-Investigator: Thomas Mok, Dr         
Sponsors and Collaborators
Hospital Authority, Hong Kong
Investigators
Principal Investigator: Wai Cho Yu, Dr Department of Medicine & Geriatrics, Princess Margaret Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00578825     History of Changes
Other Study ID Numbers: KW/FR/04-009, HARECCTR0500028, NTWC/CREC/349/05
Study First Received: December 20, 2007
Last Updated: August 21, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
Severe acute respiratory syndrome

Additional relevant MeSH terms:
Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Ribavirin
Ritonavir
Lopinavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on August 20, 2014