Status:
TERMINATED
Azithromycin Added to Hydrochloroquine in Patients Admitted to Intensive Care With COVID-19: Randomised Controlled Trial
Lead Sponsor:
Frantisek Duska, MD, PhD
Collaborating Sponsors:
Masaryk Hospital Usti nad Labem
University Hospital Pilsen
Conditions:
COVID-19
Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Trial design: Prospective, multi-centre, randomised, pragmatic, double blind trial Methods: Participants: Adult (\>18 years) within 24 hours of admission to intensive care unit with proven or suspec...
Detailed Description
Introduction Background and objectives. In early 2020 novel Coronavirus disease (COVID-19) begun to spread from Asia to Europe and beyond forcing WHO to declare global pandemic. Infected patients shed...
Eligibility Criteria
Inclusion
- Adult (\>18 years) within 24 hours of admission to intensive care unit with proven or suspected COVID-19 infection. For the purpose of this study, intensive care unit is defined as a facility that allow continuous monitoring of vital functions and oxygen administration . It is expected that most patients will have rtPCR test known within 24 hours of admission to hospital. Nonetheless, if this is not the case (eg. due to overloaded lab facility, lack of supplies) it is possible to randomise a patient based on a strong clinical suspicion of SARS-Cov-2 infection. In case COVID-19 is not confirmed in retrospect, experimental therapy is withdrawn and the study subject is withdrawn from "per protocol" analysis of the primary and secondary outcomes, but remains in "intention-to-treat" cohort for the analysis of safety.
Exclusion
- symptoms of febrile disease for ≥1 week, pregnancy, treatment limitations in place or moribund patients, allergy or intolerance of any study treatment, incl. long QT syndromes, myasthenia gravis, allergies or known deficiency of glucose-6-phosphate dehydrogenase, participation in another outcome-based interventional trial within last 30 days, patients taking Hydrochloroquine for other indication than COVID-19.
Key Trial Info
Start Date :
May 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04339816
Start Date
May 13 2020
End Date
November 4 2020
Last Update
November 6 2020
Active Locations (1)
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1
František Duška
Prague, Česká Republika, Czechia, 10034