Study Stopped
Recommended by the DSMB
Proactive Protection With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID-19
ProPAC-COVID
1 other identifier
interventional
117
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2020
Shorter than P25 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2020
CompletedFirst Posted
Study publicly available on registry
March 26, 2020
CompletedStudy Start
First participant enrolled
April 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2021
CompletedResults Posted
Study results publicly available
June 28, 2021
CompletedJune 29, 2021
June 1, 2021
10 months
March 23, 2020
June 15, 2021
June 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Days Alive and Discharged From Hospital Within 14 Days
14 days
Secondary Outcomes (14)
Categorization of Hospitalization Status
14 days
Length of Stay in ICU
14 days
Number of Participants on Non-invasive Ventilation (NIV) During Hospitalization
14 days
Mortality
30 days
Length of Hospitalization
14 days
- +9 more secondary outcomes
Study Arms (2)
Control
PLACEBO COMPARATORThis 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
Intervention
ACTIVE COMPARATORThis 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
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
Related Publications (2)
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.
PMID: 33081817DERIVEDSivapalan 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.
PMID: 32522282DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Early termination based on recommendations from the DSMB leading to small numbers of subjects analyzed.
Results Point of Contact
- Title
- Prof. Jens-Ulrik Stæhr Jensen, MD PHD
- Organization
- Gentofte Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2020
First Posted
March 26, 2020
Study Start
April 6, 2020
Primary Completion
February 2, 2021
Study Completion
February 2, 2021
Last Updated
June 29, 2021
Results First Posted
June 28, 2021
Record last verified: 2021-06