Hydroxychloroquine as a treatment for coronavirus disease COVID-19

Phase 1

• Conditions: Patients with documented respiratory infection with coronavirus SARS COV 2; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-000890-25-FR
• Lead Sponsor: Fondation Méditerranée Infection (FMI) - IHU Méditerranée Infection

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-10
• Last Update Posted: 23 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

- Women and men with documented respiratory infection with Coronavirus SARS CoV 2
- Teenager girls and boys aged more than 12 years old
- Persons who have given their free and informed consent and have signed the written form.

Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Pregnant woman
-Child less than 12 years-old
-Known hypersensitivity to chloroquine or hydroxy chloroquine.
-Feeding
-Retinopathy
-Known deficit in G6PD
-Refusal to participate in the study
-Patient with known QT prolongation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified