efficacy and safety of a bitherapy by hydroxychloroquine + azythromycin vs monotherapy by hydroxychoroquine in adult patients with documentated infection by covid19

Phase 1

• Conditions: infection COVID 19; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001406-27-FR
• Lead Sponsor: niversity Hospital of Montpellier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-03
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Written informed consent
Adult under 75 years old
- documented infection with SARS CoV 2 (positive virological test) within 96 h before randomization
- COVID-19 symptoms occurring within 10 days of randomization
- Radiographic or tomography signs of pneumonia (infiltrates)
- Hospitalized patient (outside the intensive care unit) with either a moderate clinical form (defined as not requiring oxygen therapy at the time of randomization), or a severe non-resuscitative clinical form (defined as requiring oxygen therapy by nasal tube or mask with an oxygen flow <6 l / min)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

-- admission to intensive care at the time of selection
- contraindication to IMPs
Oxygen saturation rate low defined as
- <90% in ambient air
- <94% with oxygen therapy ? 3 l / min
need for oxygen therapy= 6 l / min or mechanical ventilation
ALT or ASAT rate> 5 LSN
renal failure (DGFe <30 ml / min) or dialysis
Pregnancy or breastfeeding
Retinopathy
Known G6PD deficiency
History of heart rhythm disorder or QT prolongation
Prolongation of the QT space on an ECG dating at the time of selection of less than 24 hours: QTc> 450 ms
- hydoxychloroquine contra indication (citalopram, escitalopram, hydroxyzine, domperidone and piperaquine);
- Taking drugs known to prolong the QT interval or likely to induce a cardiac arrhythmia such as anti-arrhythmics of class IA and III, tricyclic antidepressants, antipsychotics
- Participation in another clinical trial with an experimental treatment of COVID-19
- A Concomitant treatment with possible action on SARS-CoV-2 is not authorized if it is administered less than 24 hours before the administration of the IMP

Study & Design

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