Back to resultsA 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
Primary Purpose
Severe Acute Respiratory Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lopinavir / Ritonavir plus Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Severe Acute Respiratory Syndrome focused on measuring Severe acute respiratory syndrome
Eligibility 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.
Sites / Locations
- Department of Health
- Kowloon Hospital
- Prince of Wales Hospital
- Princess Margaret Hospital
- Queen Mary Hospital
- The Chinese University of Hong Kong
- The University of Hong Kong
- Tuen Mun Hospital
- United Christian Hospital
Outcomes
Primary Outcome Measures
Development of severe SARS
Secondary Outcome Measures
Adverse events
SARS-CoV Viral load
Immunological profile
Full Information
NCT ID
NCT00578825
First Posted
December 20, 2007
Last Updated
August 21, 2013
Sponsor
Hospital Authority, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00578825
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Authority, Hong Kong
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Respiratory Syndrome
Keywords
Severe acute respiratory syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
340 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lopinavir / Ritonavir plus Ribavirin
Primary Outcome Measure Information:
Title
Development of severe SARS
Time Frame
Any time during the acute illness
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
Throughout the illness period
Title
SARS-CoV Viral load
Time Frame
Throughout the illness period
Title
Immunological profile
Time Frame
Throughout the illness period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wai Cho Yu, Dr
Phone
(852) 2990 3737
Email
yuwc@ha.org.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai Cho Yu, Dr
Organizational Affiliation
Department of Medicine & Geriatrics, Princess Margaret Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Health
City
Hong Kong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wilina Lim, Dr
Facility Name
Kowloon Hospital
City
Hong Kong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Mok, Dr
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
China
Facility Name
Princess Margaret Hospital
City
Hong Kong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ST Lai, Dr
First Name & Middle Initial & Last Name & Degree
KL Au, Dr
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis Lo, Prof
First Name & Middle Initial & Last Name & Degree
Christopher Lam, Prof
First Name & Middle Initial & Last Name & Degree
David Hui, Prof
Facility Name
The University of Hong Kong
City
Hong Kong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malik Peiris, Prof
First Name & Middle Initial & Last Name & Degree
Kenneth Tsang, Prof
First Name & Middle Initial & Last Name & Degree
KY Yuen, Prof
Facility Name
Tuen Mun Hospital
City
Hong Kong
Country
China
Facility Name
United Christian Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
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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