A trial to compare standard of care (SOC) alone with SOC plus hydroxychloroquine or SOC with a combination of hydroxycholorquine and azithromysin in the treatment of coronovirus

Phase 1

• Conditions: SARS-CoV-2 PCR-positive population; MedDRA version: 20.0Level: PTClassification code 10070255Term: Coronavirus test positiveSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001265-36-IE
• Lead Sponsor: niversity College Dublin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-07
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 267

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
F.1.3.1 Number of subjects for this age range 106

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
•Subjects receiving medications with a significant QT prolongation potential (if these treatments cannot be discontinued)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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