infection COVID 19
Conditions
Interventions
Trade Name: plaquenil
Pharmaceutical Form: Tablet
CAS Number: 747-36-4
Other descriptive name: HYDROXYCHLOROQUINE SULFATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
University Hospital of Montpellier
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: -- admission to intensive care at the time of selection - contraindication to IMPs Oxygen saturation rate low defined as - 5 LSN renal failure (DGFe 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): At least 1 level improvement in clinical status assessed by a level ordinal scale (at least 1 level) between D1 and D11 : 1. Not hospitalized, no limitation of activities 2. Not hospitalized, limitation of activities; 3. Hospitalized, not requiring oxygen supplementation 4. Hospitalized, requiring oxygen supplementation 5. Hospitalized, non-invasive ventilation or high flow oxygen device 6. Hospitalized, under invasive mechanical ventilation or ECMO (extracorporeal membrane oxygenation) 7. Death;Main Objective: Evaluation of efficacy of a bitherapy by hydroxychloroquine + azythromycin vs monotherapy by hydroxychoroquine administered for 10 days, on patient infected with SarS COV 2 with either a moderate clinical form (level 3), or a severe non-resuscitative clinical form (level 4);Secondary Objective: - Evaluation of the safety of a bitherapy by hydroxychloroquine + azythromycin vs monotherapy by hydroxychoroquine - Need of oxygenotherapy - virological, and pharmacokinetic assessment of each treatment -PAtient transfer in ICU. - hospitalization duration Vital status Adverses event;Timepoint(s) of evaluation of this end point: D11 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.clinical status 2.variation of clinical and respiratory parameter 3.Adverse event 4.Virological (qualitative and quantitative PCR) and immunological evaluation at D5, D10, D15 5.pharmacokinetic evaluation at D3 D5 D8 and D11 6. oxygenotherapy duration 7. Hospitalization duration 8 mortality 9. ICU transfer 10 QTc prolongation 11.Variation of pulmonary CT images between D1 and D11, with centralized blind analysis by independent expert reader;Timepoint(s) of evaluation of this end point: 1.Day 3, 5,7, 11, 15, 29 2. up to Day 29 3. up to Day 29 4. Day 5, D10 and D15 5. D3 D5 D8 and D11 6. up to D15 8. up to D 29 9. up to D29 10. D2, D3 D5, D8, D11 11 D11 | — |
Countries
France
Contacts
Public ContactClaire CHAUVETON
University hospital of Montpellier
Outcome results
None listed