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NCT00578825 Clinical 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

Severe Acute Respiratory Syndrome Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00578825
Other study ID # KW/FR/04-009
Secondary ID HARECCTR0500028N
Status Not yet recruiting
Phase N/A
First received December 20, 2007
Last updated August 21, 2013

Study information
Verified date August 2013
Source Hospital Authority, Hong Kong
Contact Wai Cho Yu, Dr
Phone (852) 2990 3737
Email yuwc@ha.org.hk
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 340
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lopinavir / Ritonavir plus Ribavirin

Locations
Country Name City State
China 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

Sponsors (1)
Lead Sponsor Collaborator
Hospital Authority, Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Development of severe SARS Any time during the acute illness
Secondary Adverse events Throughout the illness period
Secondary SARS-CoV Viral load Throughout the illness period
Secondary Immunological profile Throughout the illness period
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