Hydroxychloroquine for the Treatment of SARS-CoV2 (COVID 19) : Pharmacokinetic Study

NCT04625218 | Withdrawn

• 2 other identifiers: RC31/20/01552020-A01094-35
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, observational, open, monocentric multisite, pharmacokinetic study of hydroxychloroquine in critically ill patients. The aim of this study is to assess the pharmacokinetic behavior of hydroxychloroquine in COVID-19 critically ill patients treated with crushed hydroxychloroquine tablets (administered enterally using a nasogastric tube).

Conditions

COVID-19 Pneumonia

Keywords

SARS-CoV-2; hydroxychloroquine; pharmacokinetics; bronchoalveolar lavage fluid; Intensive Care Unit

Outcome Measures

Primary Outcomes (4)

• residual plasma concentration

  residual plasma concentration measured before re-administration of the treatment

  Day 3

• residual plasma concentration

  residual plasma concentration measured before re-administration of the treatment

  Day 5

• residual plasma concentration

  residual plasma concentration measured before re-administration of the treatment

  Day 7

• residual plasma concentration

  residual plasma concentration measured before re-administration of the treatment

  Day 9

Secondary Outcomes (5)

• The number of days without artificial ventilation

  Day 28

• The length of hospital stay in intensive care

  Day 28

• Survival

  Day 28

• Viral replication in the control bronchoalveolar lavage fluid on Day 7

  Day 7

• Viral replication in the control bronchoalveolar lavage fluid on Day 14

  Day 14

Eligibility Criteria

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

Study Population

Patients hospitalized in intensive care

You may qualify if:

• Patient ≥ 18 years old,
• Hospitalized in intensive care, intubated and ventilated
• With COVID-19 pneumonia confirmed by Rt-PCR,
• Having as specific treatment hydroxychloroquine, whatever the dosage regimen
• Having had the monitoring of the residual concentrations carried out by the Pharmacokinetics and Toxicology Laboratory of the Federative Institute of Biology of the Toulouse University Hospital the clinical Pharmacology and Toxicology laboratory of the Toulouse University Hospital
• Person affiliated to a social security scheme or equivalent

You may not qualify if:

• Minor patients
• Patients refusing to participate in the study
• Contraindications to hydroxychloroquine: pre-existing retinopathy, known hypersensitivity to 4-aminoquinolines, hemolytic anemia, porphyria, G6PD deficiency, myasthenia gravis, association with citalopram, escitalopram, hydroxyzine, domperidone and piperaquine
• Patients undergoing treatment with medicines known to prolong the QT interval or likely to induce a cardiac arrhythmia such as for example anti-arrhythmics of class IA and III, tricyclic antidepressants and certain anti-infectives (in particular antibiotics of the family of macrolides and fluoroquinolones as well as trimethoprim-sulfamethoxazole).
• Pregnant or breastfeeding women

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital of Toulouse

Toulouse, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples from D1 to Day 9 of the hydroxychloroquine treatment

Study Officials

• Stéphanie RUIZ, PH

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 12, 2020
• Study Start: April 30, 2020
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

FR (1)