NCT04322396

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Virus Diseases
• Infection Viral
• Corona Virus Infection

Interventions

Type	Name	Description
DRUG	Azithromycin	Azithromycin
DRUG	Hydroxychloroquine	Hydroxychloroquine
DRUG	Placebo oral tablet	Placebo Azithromycin
DRUG	Placebo oral tablet	Placebo Hydroxychloroquine

Timeline

• Start date: 2020-04-06
• Primary completion: 2021-02-02
• Completion: 2021-02-02
• First posted: 2020-03-26
• Last updated: 2021-06-29
• Results posted: 2021-06-28

Locations

8 sites across 1 country: Denmark