Proactive Protection With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID-19 (ProPAC-COVID)
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ClinicalTrials.gov Identifier: NCT04322396 |
Recruitment Status :
Terminated
(Recommended by the DSMB)
First Posted : March 26, 2020
Results First Posted : June 28, 2021
Last Update Posted : June 29, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Virus Diseases Infection Viral Corona Virus Infection | Drug: Azithromycin Drug: Hydroxychloroquine Drug: Placebo oral tablet | Phase 2 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 117 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | April 6, 2020 |
Actual Primary Completion Date : | February 2, 2021 |
Actual Study Completion Date : | February 2, 2021 |

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 |
Drug: Placebo oral tablet
Placebo Azithromycin Drug: Placebo oral tablet 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 |
Drug: Azithromycin
Azithromycin Drug: Hydroxychloroquine Hydroxychloroquine |
- Number of Days Alive and Discharged From Hospital Within 14 Days [ Time Frame: 14 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:
- 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".
- Length of Stay in ICU [ Time Frame: 14 days ]Length of stay in intensive care unit.
- Number of Participants on Non-invasive Ventilation (NIV) During Hospitalization [ Time Frame: 14 days ]
- Mortality [ Time Frame: 30 days ]
- Length of Hospitalization [ Time Frame: 14 days ]
- Days Alive and Discharged From Hospital [ Time Frame: 30 days ]
- Mortality [ Time Frame: 90 days ]
- Mortality [ Time Frame: 365 days ]
- Number of Readmissions (All Causes) [ Time Frame: 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.
- Change in Patient's Oxygen Partial Pressure [ Time Frame: 4 days ]PaO2 measured in arterial puncture at baseline and 4 days.
- Change in Patient's Carbondioxide Partial Pressure [ Time Frame: 4 days ]PaCO2 measured in arterial puncture at baseline and 4 days.
- Change of pH in Blood [ Time Frame: 4 days ]pH measured in arterial puncture at baseline and 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.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322396
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, Denmark |
Documents provided by Chronic Obstructive Pulmonary Disease Trial Network, Denmark:
Responsible Party: | Chronic Obstructive Pulmonary Disease Trial Network, Denmark |
ClinicalTrials.gov Identifier: | NCT04322396 |
Other Study ID Numbers: |
KronLungesyg_COVID_19_protokol |
First Posted: | March 26, 2020 Key Record Dates |
Results First Posted: | June 28, 2021 |
Last Update Posted: | June 29, 2021 |
Last Verified: | June 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Infections Communicable Diseases Virus Diseases Coronavirus Infections Disease Attributes Pathologic Processes Coronaviridae Infections Nidovirales Infections RNA Virus Infections Azithromycin |
Hydroxychloroquine Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |