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

• Sponsor: Hospital Authority, Hong Kong (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00578825
• Collaborator: (none)
• Enrollment: 340
• Locations: 9
• Patients Per Site: 37.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Acute Respiratory Syndrome	Drug: Lopinavir / Ritonavir plus Ribavirin	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 340 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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

Outcome Measures

Primary Outcome Measures

1. Development of severe SARS [Any time during the acute illness]

Secondary Outcome Measures

1. Adverse events [Throughout the illness period]

2. SARS-CoV Viral load [Throughout the illness period]

3. Immunological profile [Throughout the illness period]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	Department of Health	Hong Kong		China
2	Kowloon Hospital	Hong Kong		China
3	Prince of Wales Hospital	Hong Kong		China
4	Princess Margaret Hospital	Hong Kong		China
5	Queen Mary Hospital	Hong Kong		China
6	The Chinese University of Hong Kong	Hong Kong		China
7	The University of Hong Kong	Hong Kong		China
8	Tuen Mun Hospital	Hong Kong		China
9	United Christian Hospital	Hong Kong		China

Sponsors and Collaborators

• Hospital Authority, Hong Kong

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• HAREC Clinical Trial Registry

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00578825
• Other Study ID Numbers: KW/FR/04-009; HARECCTR0500028; NTWC/CREC/349/05
• First Posted: Dec 21, 2007
• Last Update Posted: Aug 22, 2013
• Last Verified: Aug 1, 2013

• Keywords provided by , ,: Severe acute respiratory syndrome
• Additional relevant MeSH terms: Severe Acute Respiratory Syndrome; Syndrome; Ritonavir; Lopinavir; Ribavirin

Study Results

No Results Posted as of Aug 22, 2013