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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
Recruitment status was: Not yet recruiting
Sponsor:
Hospital Authority, Hong Kong
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00578825
First received: December 20, 2007
Last updated: August 21, 2013
Last verified: August 2013
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Purpose
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 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00578825
Contacts
| Contact: Wai Cho Yu, Dr | (852) 2990 3737 | yuwc@ha.org.hk |
Locations
| China | |
| Department of Health | Not yet recruiting |
| Hong Kong, China | |
| Sub-Investigator: Wilina Lim, Dr | |
| Kowloon Hospital | Not yet recruiting |
| Hong Kong, China | |
| Sub-Investigator: Thomas Mok, Dr | |
| Prince of Wales Hospital | Not yet recruiting |
| Hong Kong, China | |
| Princess Margaret Hospital | Not yet recruiting |
| Hong Kong, China | |
| Sub-Investigator: ST Lai, Dr | |
| Sub-Investigator: KL Au, Dr | |
| Queen Mary Hospital | Not yet recruiting |
| Hong Kong, China | |
| The Chinese University of Hong Kong | Not yet recruiting |
| Hong Kong, China | |
| Sub-Investigator: Dennis Lo, Prof | |
| Sub-Investigator: Christopher Lam, Prof | |
| Sub-Investigator: David Hui, Prof | |
| The University of Hong Kong | Not yet recruiting |
| Hong Kong, China | |
| Sub-Investigator: Malik Peiris, Prof | |
| Sub-Investigator: Kenneth Tsang, Prof | |
| Sub-Investigator: KY Yuen, Prof | |
| Tuen Mun Hospital | Not yet recruiting |
| Hong Kong, China | |
| United Christian Hospital | Not yet recruiting |
| Hong Kong, China | |
Sponsors and Collaborators
Hospital Authority, Hong Kong
Investigators
| 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:
|
Syndrome Severe Acute Respiratory Syndrome Coronavirus Infections Disease Pathologic Processes Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Ribavirin Ritonavir |
Lopinavir Antimetabolites 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 September 21, 2017