Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial

Phase 2

Terminated

• Conditions: H1N1 Influenza
• Interventions: Drug: Rosuvastatin or identical placebo; Drug: Placebo

• Registration Number: NCT01798602
• Lead Sponsor: Canadian Critical Care Trials Group

Brief Summary

The CHAT Pilot Trial is designed to compare rosuvastatin against placebo in patients with suspected H1N1. The pilot study will assess the feasibility of our clinical protocols, and study procedures.

Detailed Description

This trial is a pilot study to assess the feasibility and acceptability of a double blind randomized controlled trial (RCT) evaluating the efficacy of rosuvastatin as adjuvant therapy for H1N1 influenza

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2010-05
• Study Completion: 2010-08
• Status Verified: 2013-02
• Study First Submitted: 2013-02-19
• Study First Submitted QC: 2013-02-22
• Last Update Submitted: 2013-02-22
• Study First Posted: 2013-02-26
• Last Update Posted: 2013-02-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Critically ill adult patients > 16 years of age admitted to an adult ICU for any reason with suspected, probable or confirmed novel swine origin influenza A/H1N1 infection
• Requiring mechanical ventilation (invasive or non-invasive)
• Receiving antiviral therapy (any medication at any dose and for any intended duration) for < 72 hours
• Clinicians must have a 'moderate', 'high' or 'moderate to high' index of suspicion for H1N1

Exclusion Criteria

• Age < 16 years

• Do not resuscitate or re-intubate order documented on chart or anticipated withdrawal of life support

• Weight < 40 kg

• Unable to receive or unlikely to absorb enteral study drug (e.g. incomplete or complete bowel obstruction, intestinal ischemia, infarction, short bowel syndrome)

• Rosuvastatin specific exclusions:

  1. Already receiving a statin (Atorvastatin, Lovastatin, Simvastatin, Pravastatin, Rosuvastatin)
  2. Allergy or intolerance to statins
  3. Receiving niacin, fenofibrate, cyclosporine, gemfibrozil, lopinavir, ritonavir or planned use of oral contraceptives or estrogen therapy during the ICU stay
  4. CK exceeds 10 times ULN or ALT exceeds 8 times the ULN

• Severe chronic liver disease (Child-Pugh Score 11-15) (see Appendix 6)

• Previous enrolment in this trial

• Pregnancy or breast feeding

• At the time of enrolment, patients must not have received >72 hours of antiviral therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin	Rosuvastatin or identical placebo	Rosuvastatin 40 mg via nasogastric tube then 20 mg po or via nasogastric tube daily for 14 days or until hospital discharge Placebo is identical capsule with no active drug Both are crushed for administration
Placebo	Placebo	Identical drug vehicle with no active agent

Primary Outcome Measures

Name	Time	Method
Proportion of eligible patients enrolled in the CHAT study	Over 6 month period or during H1N1 pandemic	This was a pilot study whose primary goal was to evaluate the feasibility of patient recruitment during an emerging pandemic

Secondary Outcome Measures

Name	Time	Method
Adherence to the medication administration regimen as outlined in the study protocol.	2 weeks
Proportion of completed primary and secondary endpoints for the planned full CHAT trial that are collected.	6 months
The number of study withdrawals due to administration of open label statins and withdrawals of consent.	Up to 28 days or until hospital discharge
Recruitment rates by consent model.	6 months

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada