Official Title
Proactive Protection With Azithromycin and Hydroxychloroquine in Hospitalized Patients With COVID: A Randomized, Placebo-controlled Double-blinded Trial Evaluating Treatment With Azithromycin and Hydroxychloroquine to Patients With COVID-19
Brief Summary

This study explores whether patients acutely hospitalized may have shorter hospitalization and fewer admittances at Intensive Care Units by treatment with azithromycin and hydroxychloroquine.

Detailed Description

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.

Terminated
Virus Diseases
Infection Viral
Corona Virus Infection

Drug: Azithromycin

Azithromycin

Drug: Hydroxychloroquine

Hydroxychloroquine

Drug: Placebo oral tablet

Placebo Azithromycin

Drug: Placebo oral tablet

Placebo Hydroxychloroquine

Eligibility Criteria

Inclusion Criteria:

- Patient admitted to a Danish emergency department, lung medical department or medical
department

- Age >18 years

- Hospitalized <48 hours

- Positive COVID-19 test/diagnosis during the hospitalization

- Signs informed consent

Exclusion Criteria:

- If the patient uses > 5 LO2/min at time of recruitment

- Known intolerance/allergy to azithromycin or hydroxychloroquine or hypersensitivity to
quinine or 4-aminoquinolinderivates

- Pregnancy

- Breastfeeding

- Neurogenic hearing loss

- Psoriasis

- Retinopathy

- Maculopathy

- Changes in vision field

- Severe liver disease other than amoebiases

- Severe gastrointestinal, neurological or haematological disorders

- eGFR < 45 ml/min/1.73m2

- Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc
interval

- Myasthenia Gravis

- Uses Digoxin

- Glucose-6-phosphate dehydrogenase deficiency

- Porphyria

- Hypoglycemia at any time since hospitalization

- Severe mental illness which significantly impedes cooperation

- Severe linguistic problems that significantly impedes cooperation

- Treatment with sickle alkaloids

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
Denmark
Locations

Aalborg Sygehus
Aalborg, Denmark

Bispebjerg Hospital
Copenhagen, Denmark

Herlev-Gentofte Hospital
Copenhagen, Denmark

Hvidovre Hospital
Copenhagen, Denmark

Nordsjællands Hospital
Hillerød, Denmark

Odense Universitetshospital
Odense, Denmark

Roskilde Sygehus
Roskilde, Denmark

Slagelse Sygehus
Slagelse, Denmark

Chronic Obstructive Pulmonary Disease Trial Network, Denmark
NCT Number
MeSH Terms
Infections
Communicable Diseases
Virus Diseases
Coronavirus Infections
Azithromycin
Hydroxychloroquine