Collaborative H1N1 Adjuvant Treatment Pilot Trial (CHAT)
|Critically Ill H1N1/Influenza Infection||Drug: Rosuvastatin Drug: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial|
- Proportion of eligible patients enrolled in the CHAT Pilot Trial. [ Time Frame: anticipated 6 months (duration of pandemic) ]
- Adherence to the medication regimen as outlined in the study protocol. [ Time Frame: 14 day treatment course ]
- Proportion of completed primary and secondary endpoints collected for the planned full CHAT trial [ Time Frame: 90 days ]
- The number of study withdrawals due to administration of open label statins and consent withdrawals [ Time Frame: anticipated 6 month study period ]
|Study Start Date:||January 2010|
|Study Completion Date:||July 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Experimental: Drug (Rosuvastatin) Crestor
The first dose of encapsulated study drug or placebo (day 1) will be administered within 4 hours of randomization as a loading dose of 40 mg. The placebo will be identical in appearance to Rosuvastatin. Thereafter, doses of 20 mg will be administered daily starting on the next calendar day at 10 pm daily (+/- 4 hours) as a maintenance dose from days 2 to 14. If the patient is of Asian descent, is <18 years, or serum creatinine is greater than or equal to 248 μmol/L (2.8 mg/dL) dose adjustments will be made according to a dose adjustment algorithm.
Loading dose: 40 mg (day 1) Maintenance dose: 20 mg (days 2-14)
Other Name: Crestor
Placebo Comparator: Placebo
An identical appearing placebo will be administered to patients in the second study arm.
identical appearing encapsulated placebo.
Primary Objective: The primary objective of the CHAT Pilot Trial is to assess our ability to recruit the desired patient population (i.e., the proportion of eligible patients enrolled in the trial), and to conduct a scientifically rigorous international RCT under pandemic circumstances.
Secondary Objectives: To evaluate (i) adherence to the medication administration regimen. (ii) the ability for research staff to collect the required primary and secondary endpoints for the planned full CHAT trial, (iii) the number of study withdrawals due to administration of open-label statins and withdrawals of consent and (iv) the impact of the approved consent model on recruitment rates.
Study Methods (Overview): Using a web-based randomization system patients, research coordinators will assign critically ill adults treated with antiviral medication for < or equal to 72 hours and requiring mechanical ventilation to one of two treatment strategies (rosuvastatin or placebo) for 14 days. Given the need to recruit patients into the CHAT Trial under pandemic conditions, when family members may not be present to provide written informed consent, we will request either a waiver of consent or deferred consent from Research Ethics Boards (REBs) at participating centres. The Keenan Research Centre/Li Ka Shing Knowledge Institute (St Michael's Hospital, Toronto, Ontario) will be the study Methods Centre.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033955
|Canada, British Columbia|
|Vancouver General Hospital|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|St. Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3B 0Z3|
|St. Joseph's Healthcare|
|Hamilton, Ontario, Canada, L8N 4A6|
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Quebec City, Quebec, Canada, G1V 4G5|
|Centre hospitalier universitaire de Sherbrooke (CHUS)|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Principal Investigator:||John C Marshall, MD, FRCPS||St. Michael's Hospital, Toronto|
|Principal Investigator:||Karen EA Burns, MD,FRCPC,MSc||St. Michael's Hospital, Toronto|