Patients with documented respiratory infection with coronavirus SARS COV 2
Conditions
Interventions
Trade Name: Plaquenil 200 mg, comprimé pelliculé
Pharmaceutical Form: Coated tablet
Sponsors
Fondation Méditerranée Infection (FMI) - IHU Méditerranée Infection
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To shorten the period of virus carrying and thus contagion;Secondary Objective: To evaluate the clinical effectiveness of treatment on time to apyrexia, normalization of respiratory rate, and average length of hospital stay and mortality.;Primary end point(s): Results of SARS-COV2 virus detection ;Timepoint(s) of evaluation of this end point: Day 1, Day 4, Day 7 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Apyrexia, normalization of respiratory rate, and average length of hospital stay and mortality.;Timepoint(s) of evaluation of this end point: Day 1, Day 4, Day 7, Day 14 and Days of hospital discharge | — |
Countries
France
Contacts
Public ContactIHU Méditerranée Infection
Fondation Méditerranée Infection (FMI) - IHU Méditerranée Infection
Outcome results
None listed