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 recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Hospital Authority, Hong Kong.
Recruitment status was:  Not yet recruiting
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
First received: December 20, 2007
Last updated: August 21, 2013
Last verified: August 2013
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
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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

Department of Health
Hong Kong, China
Kowloon Hospital
Hong Kong, China
Prince of Wales Hospital
Hong Kong, China
Princess Margaret Hospital
Hong Kong, China
Queen Mary Hospital
Hong Kong, China
The Chinese University of Hong Kong
Hong Kong, China
The University of Hong Kong
Hong Kong, China
Tuen Mun Hospital
Hong Kong, China
United Christian Hospital
Hong Kong, China
Sponsors and Collaborators
Hospital Authority, Hong Kong
Principal Investigator: Wai Cho Yu, Dr Department of Medicine & Geriatrics, Princess Margaret Hospital
  More Information

Additional Information:
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

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

Additional relevant MeSH terms:
Severe Acute Respiratory Syndrome
Coronavirus Infections
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
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

ClinicalTrials.gov processed this record on January 19, 2017