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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-06

Study Completion Date

2021-02-02

Brief Summary

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

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Detailed Description

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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.

Conditions

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Virus Diseases Infection Viral Corona Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

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

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Placebo Azithromycin

Placebo oral tablet

Intervention Type DRUG

Placebo Hydroxychloroquine

Intervention

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

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type DRUG

Azithromycin

Hydroxychloroquine

Intervention Type DRUG

Hydroxychloroquine

Interventions

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Azithromycin

Intervention Type DRUG

Hydroxychloroquine

Intervention Type DRUG

Placebo oral tablet

Placebo Azithromycin

Intervention Type DRUG

Placebo oral tablet

Placebo Hydroxychloroquine

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No