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

Corona Virus Infection Clinical Trial

— ProPAC-COVID  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04322396
• Other study ID #: KronLungesyg_COVID_19_protokol
• Status: Terminated
• Phase: Phase 2
• Start date: April 6, 2020
• Est. completion date: February 2, 2021

Study information

• Verified date: June 2021
• Source: Chronic Obstructive Pulmonary Disease Trial Network, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 117
• Est. completion date: February 2, 2021
• Est. primary completion date: February 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus Infections
• Infection
• Infection Viral
• Virus Diseases

Intervention

Drug:
• Azithromycin
Azithromycin
• Hydroxychloroquine
Hydroxychloroquine
• Placebo oral tablet
Placebo Azithromycin
• Placebo oral tablet
Placebo Hydroxychloroquine

Locations

Country	Name	City	State
Denmark	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

Sponsors (1)

Lead Sponsor	Collaborator
Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Days Alive and Discharged From Hospital Within 14 Days		14 days
Secondary	Categorization of Hospitalization Status	The patient will be categorized into one of the following 8 categories depending on status of their hospitalization: Dead (yes/no); Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no); Hospitalized and receiving Non-invasive ventilation or "high-flow oxygen device" (yes/no); Hospitalized and given oxygen supplements different from (2) and (3) (yes/no); Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no); Hospitalized for observation (yes/no); Discharged from hospital with restriction of activity level (yes/no); Discharged from hospital without any restrictions of activity level (yes/no); Only one category can be "yes".	14 days
Secondary	Length of Stay in ICU	Length of stay in intensive care unit.	14 days
Secondary	Number of Participants on Non-invasive Ventilation (NIV) During Hospitalization		14 days
Secondary	Mortality		30 days
Secondary	Length of Hospitalization		14 days
Secondary	Days Alive and Discharged From Hospital		30 days
Secondary	Mortality		90 days
Secondary	Mortality		365 days
Secondary	Number of Readmissions (All Causes)		30 days
Secondary	Number of Days Using Non-invasive Ventilation (NIV)	Number of days using non-invasive ventilation (NIV) if on NIV during hospitalization.	14 days
Secondary	Change in Patient's Oxygen Partial Pressure	PaO2 measured in arterial puncture at baseline and 4 days.	4 days
Secondary	Change in Patient's Carbondioxide Partial Pressure	PaCO2 measured in arterial puncture at baseline and 4 days.	4 days
Secondary	Change of pH in Blood	pH measured in arterial puncture at baseline and 4 days.	4 days
Secondary	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.	14 days