Proactive Protection With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID-19 (ProPAC-COVID)

Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Status and phase: Terminated; Phase 2

Conditions: Corona Virus Infection; Infection Viral; Virus Diseases

Treatments: Drug: Hydroxychloroquine; Drug: Azithromycin; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04322396

KronLungesyg_COVID_19_protokol

Details and patient eligibility

About

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

Full 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.

Enrollment: 117 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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117 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

This arm will receive standard care and placebo in 15 days. Azithromycin placebo: Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1 Hydroxychloroquine placebo: Day 1-15: 200 mg x 2

Treatment:

Drug: Placebo oral tablet

Drug: Placebo oral tablet

Intervention

Active Comparator group

Description:

This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1 Hydroxychloroquine: Day 1-15: 200 mg x 2

Treatment:

Drug: Azithromycin

Drug: Hydroxychloroquine