Evaluation of the Pharmacokinetics and Pharmacodynamics of Hydroxychloroquine in COVID-19 Intensive Care Unit Patients

NCT04522466 | Terminated Phase 3

• 2 other identifiers: 20CH0652020-001281-11
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 4

Brief Summary

To date, no treatment has demonstrated clinical efficacy on COVID 19. However, several therapeutic strategies are being considered and are being evaluated in numerous clinical trials. Among these strategies, the use of hydroxychloroquine (HCQ) seems promising. There is very little information on how to precisely administer hydroxychloroquine to patients infected with SARS-CoV-2 in intensive care, which may be responsible for side effects, some of which are potentially serious. In addition, this treatment has a long half-life which increases the risk of accumulation and therefore toxicity. In view of the lack of knowledge on the pharmacokinetic / pharmacodynamic properties of hydroxychloroquine in intensive care patients infected with SARS-CoV-2, we propose to perform a prospective multicenter cohort study in order to collect the biological data necessary for this evaluation.

Conditions

Sars-CoV2

Keywords

SARS-CoV-2; Hydroxychloroquine; COVID-19; Intensive care unit; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics of hydroxychloroquine (HCQ)

  measured blood concentration by blood sample results.

  Up to day 21

Secondary Outcomes (3)

• Correlation between hydroxychloroquine (HCQ) concentration and cardiac toxicity (QT interval)

  Up to day 21

• Correlation between Pharmacokinetic (concentration) and pharmacodynamic (viral load) of hydroxychloroquine (HCQ)

  Day 1, Day 3, Day 5, Day 7, Day 14, Day 21

• Pharmacokinetic model

  Up to day 21

Study Arms (1)

Patients infected by SARS-CoV-2 treated by Hydroxychloroquine

EXPERIMENTAL

Blood sample on patients infected by SARS-CoV-2 treated by Hydroxychloroquine

Drug: Hydroxychloroquine (HCQ)

Interventions

Hydroxychloroquine (HCQ) DRUG

Hydroxychloroquine (HCQ) will be administered as usual practice: dosage is adjusted to maintain a concentration between 1 and 2 mg/L. Measure pharmacokinetics and pharmacodynamics of Hydroxychloroquine (HCQ).

Patients infected by SARS-CoV-2 treated by Hydroxychloroquine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients 18 years of age and older
• Patients hospitalized in the intensive care unit infected with CoV-2-SARS for whom a diagnosis of respiratory CoV-2-SARS infection has been made by nasopharyngeal swab or deep respiratory sampling.
• Patient receiving HCQ treatment as part of care or as part of a clinical trial.
• Patient affiliated or entitled to a social security scheme

You may not qualify if:

• Hypersensitivity to the active substances or to any of the following excipients: lactose monohydrate, povidone, corn starch, magnesium stearate.
• Retinopathies
• Combination with citalopram, escitalopram, hydroxyzine, domperidone and piperazine due to increased risk of ventricular rhythm disturbances, including torsades de pointes.
• Patient with known QT prolongation
• Known deficit in G6PD
• Pregnant woman

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• CHU Saint-Etienne - Laboratoire de Pharmacologie - Toxicologie - Gaz du sang: collaborator

Study Sites (4)

Groupement Hospitalier des Portes de Province

Montélimar, France

Location

Centre Hospitalier de Roanne

Roanne, France

Location

CHU Saint-Etienne

Saint-Etienne, France

Location

Clinique Mutualiste

Saint-Etienne, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sophie PERINEL, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 21, 2020
• Study Start: April 3, 2020
• Primary Completion: May 28, 2020
• Study Completion: May 28, 2020
• Last Updated: September 7, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)