This study explores whether patients acutely hospitalized may have shorter hospitalization and fewer admittances at Intensive Care Units by treatment with azithromycin and hydroxychloroquine.
In the ongoing coronavirus pandemic, COVID-19, that arose in Wuhan China, there is still sparse data in the course, risk of various complications, and in particular how patients who are hospitalized are best treated to ensure high survival and short hospitalization. Despite the rapid spread of the disease globally, there is no solid data yet to recommend any specific treatments, which is why symptomatic, organ supportive therapy including respiratory therapy in acute pulmonary failure is recommended. There has been reported a high incidence of bacterial super-infections in patients with COVID-19. Patients with COVID-19 also have a higher risk of dying because of septic shock. Thus, there is an urgent need for treatment that can improve the patient's chance of the shortest hospitalization possible, and treatment that can lower the risk of secondary infection and death. This is a randomized, placebo-controlled, double-blinded multi-center trial evaluating the effect of azithromycin and hydroxychloroquine treatment in patients with COVID-19 during hospitalization. The aim of the study is to investigate whether the treatment can shorten hospitalization, reduce the risk of non-invasive ventilation, admittance to Intensive Care Units and death.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
117
Aalborg Sygehus
Aalborg, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Herlev-Gentofte Hospital
Copenhagen, Denmark
Hvidovre Hospital
Copenhagen, Denmark
Number of Days Alive and Discharged From Hospital Within 14 Days
Time frame: 14 days
Categorization of Hospitalization Status
The patient will be categorized into one of the following 8 categories depending on status of their hospitalization: 1. Dead (yes/no) 2. Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no) 3. Hospitalized and receiving Non-invasive ventilation or "high-flow oxygen device" (yes/no) 4. Hospitalized and given oxygen supplements different from (2) and (3) (yes/no) 5. Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no) 6. Hospitalized for observation (yes/no) 7. Discharged from hospital with restriction of activity level (yes/no) 8. Discharged from hospital without any restrictions of activity level (yes/no) Only one category can be "yes".
Time frame: 14 days
Length of Stay in ICU
Length of stay in intensive care unit.
Time frame: 14 days
Number of Participants on Non-invasive Ventilation (NIV) During Hospitalization
Time frame: 14 days
Mortality
Time frame: 30 days
Length of Hospitalization
Time frame: 14 days
Days Alive and Discharged From Hospital
Time frame: 30 days
Mortality
Time frame: 90 days
Mortality
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Placebo Hydroxychloroquine
Nordsjællands Hospital
Hillerød, Denmark
Odense Universitetshospital
Odense, Denmark
Roskilde Sygehus
Roskilde, Denmark
Slagelse Sygehus
Slagelse, Denmark
Time frame: 365 days
Number of Readmissions (All Causes)
Time frame: 30 days
Number of Days Using Non-invasive Ventilation (NIV)
Number of days using non-invasive ventilation (NIV) if on NIV during hospitalization.
Time frame: 14 days
Change in Patient's Oxygen Partial Pressure
PaO2 measured in arterial puncture at baseline and 4 days.
Time frame: 4 days
Change in Patient's Carbondioxide Partial Pressure
PaCO2 measured in arterial puncture at baseline and 4 days.
Time frame: 4 days
Change of pH in Blood
pH measured in arterial puncture at baseline and 4 days.
Time frame: 4 days
Time for no Oxygen Supplement (or Regular Oxygen Supplement "LTOT")
Time for no oxygen supplement (or regular oxygen supplement "LTOT") if on oxygen during admission.
Time frame: 14 days