EUCTR2020-001265-36-IE
Active, not recruiting
Phase 1
A multicentre, prospective, randomised trial comparing standard of care (SOC) alone, SOC plus hydroxychloroquine monotherapy or SOC plus a combination of hydroxychloroquine and azithromycin in the treatment of non-critical, SARS-CoV-2 PCR-positive population not requiring immediate resuscitation or ventilation but who have evidence of clinical decline.
niversity College Dublin0 sites267 target enrollmentApril 7, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- SARS-CoV-2 PCR-positive population
- Sponsor
- niversity College Dublin
- Enrollment
- 267
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Documented Covid\-19 positive
- •Evidence of progressive clinical decline:
- •oRising inflammatory markers over a 24 hour period (increases in CRP, d\-dimer, LDH and/or ferritin above the upper limit of normal)
- •oPresence of or progression of pulmonary infiltrates on CXR (as decided by the treating physician)
- •oNew 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
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 (\<3\.0mmol/L) or hyperkalaemia (\>6\.1mmol/L) at screening
- •Hypocalcaemia (\<2\.1mmol/L) or hypercalcaemia (\>2\.6mmol/L) (corrected for albumin) at screening
Outcomes
Primary Outcomes
Not specified
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