- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04322396
Proactive Protection With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID-19 (ProPAC-COVID)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Aalborg, Denmark
- Aalborg Sygehus
-
Copenhagen, Denmark
- Bispebjerg Hospital
-
Copenhagen, Denmark
- Hvidovre Hospital
-
Copenhagen, Denmark
- Herlev-Gentofte Hospital
-
Hillerød, Denmark
- Nordsjællands Hospital
-
Odense, Denmark
- Odense Universitetshospital
-
Roskilde, Denmark
- Roskilde Sygehus
-
Slagelse, Denmark
- Slagelse Sygehus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 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 |
Placebo Azithromycin
Placebo Hydroxychloroquine
|
Active Comparator: 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 |
Hydroxychloroquine
Azithromycin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Days Alive and Discharged From Hospital Within 14 Days
Time Frame: 14 days
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 30 days
|
30 days
|
|
Mortality
Time Frame: 90 days
|
90 days
|
|
Mortality
Time Frame: 365 days
|
365 days
|
|
Categorization of Hospitalization Status
Time Frame: 14 days
|
The patient will be categorized into one of the following 8 categories depending on status of their hospitalization:
Only one category can be "yes". |
14 days
|
Length of Stay in ICU
Time Frame: 14 days
|
Length of stay in intensive care unit.
|
14 days
|
Number of Participants on Non-invasive Ventilation (NIV) During Hospitalization
Time Frame: 14 days
|
14 days
|
|
Length of Hospitalization
Time Frame: 14 days
|
14 days
|
|
Days Alive and Discharged From Hospital
Time Frame: 30 days
|
30 days
|
|
Number of Readmissions (All Causes)
Time Frame: 30 days
|
30 days
|
|
Number of Days Using Non-invasive Ventilation (NIV)
Time Frame: 14 days
|
Number of days using non-invasive ventilation (NIV) if on NIV during hospitalization.
|
14 days
|
Change in Patient's Oxygen Partial Pressure
Time Frame: 4 days
|
PaO2 measured in arterial puncture at baseline and 4 days.
|
4 days
|
Change in Patient's Carbondioxide Partial Pressure
Time Frame: 4 days
|
PaCO2 measured in arterial puncture at baseline and 4 days.
|
4 days
|
Change of pH in Blood
Time Frame: 4 days
|
pH measured in arterial puncture at baseline and 4 days.
|
4 days
|
Time for no Oxygen Supplement (or Regular Oxygen Supplement "LTOT")
Time Frame: 14 days
|
Time for no oxygen supplement (or regular oxygen supplement "LTOT") if on oxygen during admission.
|
14 days
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Sivapalan P, Ulrik CS, Lappere TS, Eklof JV, Shaker SB, Bodtger UCS, Browatzki A, Meyer CN, Weinreich UM, Laursen CB, Biering-Sorensen T, Knop FK, Lundgren JD, Jensen JS. Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a statistical analysis plan. Trials. 2020 Oct 20;21(1):867. doi: 10.1186/s13063-020-04795-0.
- Sivapalan P, Ulrik CS, Bojesen RD, Lapperre TS, Eklof JV, Hakansson KEJ, Browatzki A, Tidemansen C, Wilcke JT, Janner J, Gottlieb V, Meteran H, Porsbjerg C, Madsen BL, Moberg M, Pedersen L, Benfield TL, Lundgren JD, Knop FK, Biering-Sorensen T, Ghanizada M, Sonne TP, Bodtger UCS, Jensen SG, Rasmussen DB, Brondum E, Tupper OD, Sorensen SW, Alstrup G, Laursen CB, Moller UW, Sverrild A, Jensen JS. Proactive Prophylaxis With Azithromycin and HydroxyChloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID): A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 10;21(1):513. doi: 10.1186/s13063-020-04409-9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Disease Attributes
- Coronavirus Infections
- Infections
- Communicable Diseases
- Virus Diseases
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Azithromycin
- Hydroxychloroquine
Other Study ID Numbers
- KronLungesyg_COVID_19_protokol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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