NCT00578825

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2007

Completed
Last Updated

August 22, 2013

Status Verified

August 1, 2013

First QC Date

December 20, 2007

Last Update Submit

August 21, 2013

Conditions

Keywords

Severe acute respiratory syndrome

Outcome Measures

Primary Outcomes (1)

  • Development of severe SARS

    Any time during the acute illness

Secondary Outcomes (3)

  • Adverse events

    Throughout the illness period

  • SARS-CoV Viral load

    Throughout the illness period

  • Immunological profile

    Throughout the illness period

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female over the age of 18 with a diagnosis of SARS and with valid consent will be recruited.

You may not qualify if:

  • Subjects with medical conditions that makes the prescription of study medications unsafe are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Department of Health

Hong Kong, China

Location

Kowloon Hospital

Hong Kong, China

Location

Prince of Wales Hospital

Hong Kong, China

Location

Princess Margaret Hospital

Hong Kong, China

Location

Queen Mary Hospital

Hong Kong, China

Location

The Chinese University of Hong Kong

Hong Kong, China

Location

The University of Hong Kong

Hong Kong, China

Location

Tuen Mun Hospital

Hong Kong, China

Location

United Christian Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Interventions

LopinavirRitonavirRibavirin

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsAzolesRibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Wai Cho Yu, Dr

    Department of Medicine & Geriatrics, Princess Margaret Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wai Cho Yu, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 21, 2007

Last Updated

August 22, 2013

Record last verified: 2013-08

Locations