SARS-CoV-2 PCR-positive population MedDRA version: 20.0 Level: PT Classification code 10070255 Term: Coronavirus test positive System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Plaquenil
Product Name: Plaquenil
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Hydroxychloroquine sulfate
CAS Number: 118-42-3
Other descriptive name: HYDROXYCHLOROQUINE SU
Sponsors
University College Dublin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Documented Covid-19 positive • Evidence of progressive clinical decline: o Rising inflammatory markers over a 24 hour period (increases in CRP, d-dimer, LDH and/or ferritin above the upper limit of normal) o Presence of or progression of pulmonary infiltrates on CXR (as decided by the treating physician) o New hypoxia requiring >2l/min/28% FiO2 to maintain oxygen saturations =94% (or 88-92% in patients with chronic hypercapnic respiratory failure) 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 161 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 106
Exclusion criteria
Exclusion criteria: • Pregnant or breastfeeding woman • Known hypersensitivity to chloroquine or hydroxy chloroquine or any excipients • Known hypersensitivity to azithromycin, erythromycin or any of the macrolide or ketolide antibiotics or any of the excipients • Known deficit in G6PD • Known retinopathy • Patient with history of cardiac arrythmia related to QT prolongation • Suspected acute cardiogenic pulmonary oedema at the time of enrolment • QTc >500ms on two consecutive ECG measurements at screening • Hypokalaemia (6.1mmol/L) at screening • Hypocalcaemia (2.6mmol/L) (corrected for albumin) at screening • Subjects receiving medications with a significant QT prolongation potential (if these treatments cannot be discontinued)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of azithromycin monotherapy, hydroxychloroquine monotherapy or a combination of hydroxychloroquine and azithromycin as potential therapies in a non-critical, SARS-CoV-2 PCR-positive population not requiring immediate resuscitation or ventilation but who have evidence of progressive clinical decline.;Secondary Objective: Not applicable;Primary end point(s): Composite primary endpoint is time to progression to intubation, non-invasive ventilation or death.;Timepoint(s) of evaluation of this end point: Time to event | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. All-cause mortality at 14, 30 and 60 days 2. Time to clearance of COVID19 from nasopharyngeal pathway (PCR) 3. Change in inflammatory markers at day 7, 14 and 30 4. Change in supplemental oxygen requirements at day 7, 14 and 30 5. Length of stay in ICU 6. Time from intubation to extubation 7. Progression to moderate to severe respiratory failure as defined by PaO2/FiO2=200mmHg and PEEP =5cmH2O 8. Time to discharge from hospital 9. Change/normalisation of A-a gradient 10. Resolution of radiological infiltrates ;Timepoint(s) of evaluation of this end point: 1. All-cause mortality at 14, 30 and 60 days 2. Time to clearance of COVID19 from nasopharyngeal pathway (PCR) - up to 60 days 3. Change in inflammatory markers at day 7, 14 and 30 4. Change in supplemental oxygen requirements at day 7, 14 and 30 5. Length of stay in ICU (within 60 day study duration) 6. Time from intubation to extubation (time to event - within study duration) 7. Progression to moderate to severe respiratory failure as defined by PaO2/FiO2=200mmHg and PEEP =5cmH2O (time to event, within study duration) 8. Time to discharge from hospital (time to event within study duration) 9. Change/normalisation of A-a gradient (time to event within study duration) 10. Resolution of radiological infiltrates (within 60 day study duration) | — |
Countries
Ireland
Contacts
Public ContactQRAM
University College Dublin
Outcome results
None listed