EUCTR2020-001456-18-CZ
Active, not recruiting
Phase 1
Azithromycin added to Hydrochloroquine in Patients Admitted to Intensive Care due to Coronavirus Disease 2019 (COVID-19) - Randomised Controlled Trial, phase III - AZIQUINE-ICU-25032020
adacní fond Donatio intensivistam0 sites240 target enrollmentApril 8, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- adacní fond Donatio intensivistam
- Enrollment
- 240
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) adult (\>18 years)
- •2\) within 24 hours of admission to intensive care unit
- •3\) proven or suspected COVID\-19 infection
- •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 120
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 120
Exclusion Criteria
- •1\) Symptoms of febrile disease for \=1 week at enrolement
- •2\) Pregnancy or inability/unwillingness to perform pregnancy test at and 28 days after enrolment
- •3\) Treatment limitations in place or moribund patients
- •4\) Allergy, intolerance or contraindication to any study drug, incl. long QT syndromes, myasthenia gravis, allergies or known deficiency of glucose\-6\-phosphate dehydrogenase
- •5\) Known HIV positivity
- •6\) Significant liver disease such as cirrhosis Child\-Pugh C or active hepatitis B or C
- •7\) Known stage IV chronic kidney disease, on dialysis at enrolment or imminent need of it
- •8\) Participation in another outcome\-based interventional trial within last 30 days
- •9\) Patients taking Hydroxychloroquine for other indication than to treat COVID\-19\.
- •Criteria for withdrawal from the study:
Outcomes
Primary Outcomes
Not specified
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