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

August 21, 2013 updated by: Hospital Authority, Hong Kong
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wai Cho Yu, Dr
  • Phone Number: (852) 2990 3737
  • Email: yuwc@ha.org.hk

Study Locations

  • China
      • Hong Kong, China
        • The University of Hong Kong
        • Sub-Investigator:
          • Malik Peiris, Prof
        • Sub-Investigator:
          • Kenneth Tsang, Prof
        • Sub-Investigator:
          • KY Yuen, Prof
      • Hong Kong, China
        • Prince of Wales Hospital
      • Hong Kong, China
        • The Chinese University of Hong Kong
        • Sub-Investigator:
          • Dennis Lo, Prof
        • Sub-Investigator:
          • Christopher Lam, Prof
        • Sub-Investigator:
          • David Hui, Prof
      • Hong Kong, China
        • Queen Mary Hospital
      • Hong Kong, China
        • Tuen Mun Hospital
      • Hong Kong, China
        • Princess Margaret Hospital
        • Sub-Investigator:
          • ST Lai, Dr
        • Sub-Investigator:
          • KL Au, Dr
      • Hong Kong, China
        • United Christian Hospital
      • Hong Kong, China
        • Department of Health
        • Sub-Investigator:
          • Wilina Lim, Dr
      • Hong Kong, China
        • Kowloon Hospital
        • Sub-Investigator:
          • Thomas Mok, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of severe SARS
Time Frame: Any time during the acute illness
Any time during the acute illness

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: Throughout the illness period
Throughout the illness period
SARS-CoV Viral load
Time Frame: Throughout the illness period
Throughout the illness period
Immunological profile
Time Frame: Throughout the illness period
Throughout the illness period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Authority, Hong Kong

Investigators

  • Principal Investigator: Wai Cho Yu, Dr, Department of Medicine & Geriatrics, Princess Margaret Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 20, 2007

First Posted (Estimate)

December 21, 2007

Study Record Updates

Last Update Posted (Estimate)

August 22, 2013

Last Update Submitted That Met QC Criteria

August 21, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KW/FR/04-009
  • HARECCTR0500028
  • NTWC/CREC/349/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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