Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Collaborative H1N1 Adjuvant Treatment Pilot Trial

NCT01033955

Critically Ill H1N1/Influenza Infection

TERMINATED PHASE2

STIP: Statin Trial for Influenza Patients

NCT00970606

Acute Respiratory Distress Syndrome Influenza H1N1 Influenza

TERMINATED NA

Testing the AVI-7100 Flu Drug in Healthy Volunteers

NCT01747148

Influenza

COMPLETED PHASE1

Safety and Efficacy Study of Interferon to Treat Patients Hospitalized for Influenza

NCT01227798

Influenza

UNKNOWN PHASE1/PHASE2

A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A

NCT05567783

Influenza A

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

H1N1 Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rosuvastatin

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

Group Type EXPERIMENTAL

Rosuvastatin or identical placebo

Intervention Type DRUG

Tablet crushed for administration via feeding tube

Placebo

Identical drug vehicle with no active agent

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Identical placebo for rosuvastatin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rosuvastatin or identical placebo

Tablet crushed for administration via feeding tube

Intervention Type DRUG

Placebo

Identical placebo for rosuvastatin

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Crestor Placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No