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Azithromycin for treatment of hospitalised COVID-19 patients: a randomised, multicentre, open-label clinical trial (DAWn-AZITHRO)

Iwein Gyselinck, Laurens Liesenborghs, Ann Belmans, Matthias M. Engelen, Albrecht Betrains, Quentin Van Thillo, Pham Anh Hong Nguyen, Pieter Goeminne, Ann-Catherine Soenen, Nikolaas De Maeyer, Charles Pilette, Emmanuelle Papleux, Eef Vanderhelst, Aurélie Derweduwen, Patrick Alexander, Bernard Bouckaert, Jean-Benoît Martinot, Lynn Decoster, Kurt Vandeurzen, Rob Schildermans, Peter Verhamme, Wim Janssens, Robin Vos for the DAWn-AZITHRO investigators
ERJ Open Research 2022 8: 00610-2021; DOI: 10.1183/23120541.00610-2021
Iwein Gyselinck
1Dept of Respiratory Diseases, UZ Leuven and CHROMETA, Research group BREATHE, KU Leuven, Leuven, Belgium
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  • For correspondence: iwein.gyselinck@kuleuven.be
Laurens Liesenborghs
2Laboratory of Virology and Chemotherapy, Dept of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium
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Ann Belmans
3Leuven Biostatistics and Statistical Bioinformatics Centre (L-BioStat), KU Leuven, Leuven and University Hasselt, Hasselt, Belgium
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Matthias M. Engelen
4Dept of Cardiovascular Diseases, UZ Leuven and Centre for Molecular and Vascular Biology, KU Leuven, Leuven, Belgium
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Albrecht Betrains
5Dept of General Internal Medicine, University Hospitals Leuven, Leuven, Belgium
6Dept of Microbiology, Immunology, and Transplantation, KU Leuven, Leuven, Belgium
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Quentin Van Thillo
7Center for Cancer Biology, Vlaams Instituut voor Biotechnologie (VIB), Leuven, Belgium
8Center for Human Genetics, KU Leuven, Leuven, Belgium
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Pham Anh Hong Nguyen
9Dept of Respiratory Diseases, Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium
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Pieter Goeminne
10Dept of Respiratory Diseases, AZ Nikolaas, Sint-Niklaas, Belgium
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Ann-Catherine Soenen
11Dept of Respiratory Diseases, Jan Yperman Ziekenhuis, Ypres, Belgium
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Nikolaas De Maeyer
12Dept of Respiratory Diseases, Heilig Hart Ziekenhuis, Leuven, Belgium
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Charles Pilette
13Dept of Respiratory Diseases, Cliniques Universitaires Saint-Luc, Brussels, Belgium
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Emmanuelle Papleux
14Dept of Respiratory Diseases, Hôpitaux Iris Sud, Brussels, Belgium
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Eef Vanderhelst
15Dept of Respiratory Diseases, University Hospital UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium
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Aurélie Derweduwen
16Dept of Respiratory Diseases, AZ Klina, Brasschaat, Belgium
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Patrick Alexander
17Dept of Respiratory Diseases, AZ Glorieux, Ronse, Belgium
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Bernard Bouckaert
18Dept of Respiratory Diseases, AZ Delta, Roeselare, Belgium
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Jean-Benoît Martinot
19Dept of Respiratory Diseases, Centre Hospitalier Universitaire-UC Louvain, Namur, Belgium
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Lynn Decoster
20Dept of Respiratory Diseases, AZ Turnhout, Turnhout, Belgium
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Kurt Vandeurzen
21Dept of Respiratory Diseases, Mariaziekenhuis Noord Limburg, Pelt, Belgium
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Rob Schildermans
22Dept of Respiratory Diseases, AZ Sint Lucas, Bruges, Belgium
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Peter Verhamme
23Dept of Cardiovascular Diseases, UZ Leuven and Centre for Molecular and Vascular Biology, KU Leuven, Leuven, Belgium
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Wim Janssens
1Dept of Respiratory Diseases, UZ Leuven and CHROMETA, Research group BREATHE, KU Leuven, Leuven, Belgium
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Robin Vos
1Dept of Respiratory Diseases, UZ Leuven and CHROMETA, Research group BREATHE, KU Leuven, Leuven, Belgium
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  • Article
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Figures

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  • FIGURE 1
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    FIGURE 1

    Primary end-point: cumulative incidence function of sustained clinical improvement or live discharge (full analysis set). AZITHRO: azithromycin; SOC: standard of care.

  • FIGURE 2
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    FIGURE 2

    Forest plot subgroup analyses for primary end-point: time to sustained clinical improvement or discharge (full analysis set). AZITHRO: azithromycin; SOC: standard of care; NC: not calculated.

  • FIGURE 3
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    FIGURE 3

    Bar chart of daily clinical status (full analysis set). AZITHRO: azithromycin; SOC: standard of care; Hosp.: hospitalised; inv: invasive; MV: mechanical ventilation; ECMO: extracorporeal membrane oxygenation.

Tables

  • Figures
  • Supplementary Materials
  • TABLE 1

    Subject disposition and baseline information: full analysis set/safety set

    Full analysis set=safety setStatisticAZITHRO + SOCSOCTotal
    Total number of patientsn11964183
    Demographics
     Age yearsMean±sd63±1559±1562±15
     Femalen/N (%)40/119 (33.61)30/64 (46.88)70/183 (38.25)
    Ethnicity
     Caucasiann/N (%)104/119 (87.39)55/64 (85.94)159/183 (86.89)
     North Africa and Middle Eastn/N (%)11/119 (9.24)5/64 (7.69)16/183 (8.74)
     Black or sub-Sahara (Africa)n/N (%)3/119 (2.52)1/64 (1.56)4/183 (2.19)
     Othern/N (%)1/119 (0.84)3/64 (4.68)4/183 (2.19)
    Medical history
     Diabetes mellitusn/N (%)22/119 (18.49)9/64 (14.06)31/183 (16.94)
     Arterial hypertensionn/N (%)55/119 (46.22)27/64 (42.19)82/183 (44.81)
     Arrhythmian/N (%)19/119 (15.97)12/64 (18.75)31/183 (16.94)
     Smoking status
      Activen/N (%)5/110 (4.55)4/55 (7.27)9/165 (5.45)
      Formern/N (%)37/110 (33.64)20/55 (36.36)57/165 (34.55)
      Nevern/N (%)68/110 (61.82)31/55 (56.36)99/165 (60.00)
     Chronic pulmonary disease#n/N (%)4/119 (3.36)2/63 (3.17)6/182 (3.30)
     COPDn/N (%)7/119 (5.88)8/64 (12.50)15/183 (8.20)
     Asthman/N (%)10/119 (8.40)5/64 (7.81)15/183 (8.20)
     Heart failuren/N (%)8/119 (6.72)3/64 (4.69)11/183 (6.01)
     Ischaemic heart diseasen/N (%)10/119 (8.40)8/64 (12.50)18/183 (9.84)
     Chronic kidney diseasen/N (%)10/119 (8.40)6/64 (9.38)16/183 (8.74)
    Respiratory status at first presentation
     Signs of respiratory distress at first  presentation (i.e. oxygen saturation  <93%, PaO2/FIO2 <300 mmHg,  respiratory rate >30 breaths·min−1)n/N (%)57/119 (47.90)33/61 (54.10)90/180 (50.00)
     Respiratory support within first 2 h
      Oxygen support (oxygen mask or   nasal prongs)n/N (%)89/119 (74.79)46/63 (73.02)135/182 (74.18)
      High-flow oxygen support or   noninvasive ventilationn/N (%)5/119 (4.20)4/64 (6.25)9/183 (4.92)
      Mechanical ventilationn/N (%)0/119 (0.00)3/64 (4.69)3/183 (1.64)
      ECMOn/N (%)1/119 (0.84)0/64 (0.00)1/183 (0.55)
    Clinical status at baseline
     3)  Hosp., not requiring supplemental oxygenn/N (%)22/119 (18.49)14/64 (21.88)36/183 (19.67)
     4)  Hosp., requiring supplemental oxygenn/N (%)88/119 (73.95)43/64 (67.19)131/183 (71.58)
     5)  Hosp., on noninvasive ventilationn/N (%)9/119 (7.56)5/64 (7.81)14/183 (7.65)
     6)  Hosp., on invasive MV or ECMOn/N (%)0/119 (0.00)2/64 (3.13)2/183 (1.09)
     7)  Deathn/N (%)0/119 (0.00)0/64 (0.00)0/183 (0.00)
    Laboratory parameters at baseline
     CRP mg·L−1Ref. ≤5Median (Q1–Q3)73.8 (35.2–125.8)59.5 (23.5–93.3)68.0 (33.1–119.2)
     WBC 109/LRef. 4.0–10.0Median (Q1–Q3)6.0 (4.2–8.0)5.6 (4.1–8.0)5.8 (4.2–8.0)
     Lymphocytes 109/LRef. 1.2–3.6Median (Q1–Q3)1.0 (0.7–1.4)1.0 (0.7–1.3)1.0 (0.7–1.4)
     Neutrophils 109/LRef. 2.5–7.8Median (Q1–Q3)4.4 (2.9–6.5)4.5 (3.4–6.7)4.5 (3.0–6.6)
     Ferritin µg·L−1Ref. 30–400Median (Q1–Q3)722.5 (408.0–1057.0)748.0 (529.0–1420.0)736.0 (492.0–1259.0)
     D-dimer µg·L−1Ref. ≤500Median (Q1–Q3)743.0 (466.0–1174.0)670.0 (378.0–958.0)723.5 (455.5–1160.0)
     Fibrinogen g·L−1Ref. 2.0–3.93Median (Q1–Q3)7.7 (5.6–560.0)139.2 (4.5–547.0)9.3 (5.3–547.0)
     eGFR mL·min−1Ref. ≥60Median (Q1–Q3)82.0 (64.0–90.0)88.0 (74.0–90.0)85.0 (65.0–90.0)
    ECG at baseline
     QTc (MS) (Fridericia formula)n, mean±sdn=111, 418.9±25.3n=57, 416.5±28.6n=168, 418.1±26.4
    Symptom onset
     Time from symptom onset to  randomisation, daysMedian (Q1–Q3)7 (4–10)7 (5–10)7 (5–10)

    AZITHRO: azithromycin; SOC: standard of care; PaO2: arterial oxygen tension; FIO2: inspiratory oxygen fraction; ECMO: extracorporeal membrane oxygenation; Hosp.: hospitalised; MV: mechanical ventilation; Ref: reference value; CRP: C-reactive protein; WBC: white blood cell count; eGFR: estimated glomerular filtration rate. #: not COPD or asthma.

    • TABLE 2

      Trial primary and secondary end-points: full analysis set (FAS)

      Full analysis set (n=183)StatisticEstimate (95% CI)Treatment effectEstimate (95% CI)p-value
      AZITHROSOC
      Primary outcome
       Incidence of clinical improvement or live  dischargeSubdistribution HR#1.023 (0.758–1.379)0.8839
        At 15 daysCIF¶ (%)78.2 (69.5–84.6)81.3 (69.0–89.0)
        At 29 daysCIF¶ (%)86.6 (78.9–91.6)89.1 (77.8–94.8)
       Time to sustained clinical improvement or live  dischargeMedian (days)6 (6–8)8 (6–10)
      Secondary outcomes (compared to FAS, total n-values may be lower than n=119 for AZITHRO and n=64 for SOC due to missing values+)
       Clinical status at day 15n/N (%)Common OR of having lower clinical status at day 15§0.83 (0.47–1.53)0.5776
        1) Not hosp., no limitations14/97 (14.58)11/53 (20.75)
        2) Not hosp., limitations50/97 (51.55)28/53 (52.83)
        3) Hosp., no supplemental oxygen7/97 (7.22)2/53 (3.77)
        4) Hosp., requiring oxygen10/97 (10.31)4/53 (7.55)
        5) Hosp., noninvasive ventilation5/97 (5.15)3/53 (5.66)
        6) Hospitalised, MV or ECMO7/97 (7.22)4/53 (7.55)
        7) Death4/97 (4.12)1/53 (1.89)
       Cumulative clinical status up to day 15Geometric meanƒ42.61 (39.66–45.77)42.60 (38.64–46.98)Treatment ratio##1.00 (0.90–1.12)0.9508
       All-cause mortality
        15 daysKM (%)3.4 (1.3–8.7)1.6 (0.2–10.6)HR¶¶1.799 (0.201–16.09)0.5996
        29 daysKM (%)7.6 (4.0–14.0)6.5 (2.5–16.3)HR¶¶1.109 (0.339–3.628)0.8666
       ICU (29 days)
        Incidence (all patients)¶¶¶CIF¶ (%)26.1 (18.5–34.2)23.4 (13.9–34.4)Subdistribution HR#1.066 (0.572–1.985)0.8412
        Duration of ICU stay (ICU admitted patients)Median (days)11 (7–18)17 (3–28)Subdistribution HR for live discharge from ICU#1.293 (0.661–2.529)0.4534
       Mechanical ventilation (29 days)
        Incidence (all patients)¶¶¶CIF¶ (%)12.0 (6.9–18.6)15.6 (8.0–25.6)Subdistribution HR#0.738 (0.313–1.741)0.4838
        Duration of MV (MV patients)Median (days)13 (NC–NC)19 (NC–NC)Subdistribution HR for live weaning from MV#0.897 (0.263–3.034)0.8609
       Supplemental oxygen (29 days)
        Incidence (all patients)¶¶¶CIF¶ (%)83.2 (75.1–88.9)79.7 (67.4–87.8)Subdistribution HR#0.998 (0.837–1.191)0.7811
        Duration of supplemental oxygen (patients with   supplemental oxygen)#Median (days)6 (5–8)7 (5–11)Subdistribution HR for live weaning from oxygen#1.042 (0.737–1.479)0.9465
       Hospital stay (29 days)Subdistribution HR for live
        Occurrence of live hospital dischargeCIF¶ (%)85.8 (78.0–91.0)84.4 (72.5–91.4) hospital discharge#1.064 (0.780–1.451)0.6954
        Duration of hospital stay (days)#Median (days)7 (6–8)8 (6–9)
      Safety outcome
       Combined cardiac end-point (hs-troponin  >0.5 ng·mL−1 and/or ventricular arrhythmia  requiring intervention and/or sudden cardiac  death)n/N (%)24/119 (20.17)12/64 (18.75)OR++1.40 (0.61–3.19)0.4265
      Exploratory outcomes
       Normal CT at 5–7 weeksn/N (%)25/75 (33.33)12/40 (30.00)OR§§1.56 (0.64–3.79)0.3233
       DLCO % predictedEstimated meanƒƒ (%)66.49 (59.96–73.02)67.00 (57.91–76.09)Treatment difference###0.22 (−11.1–11.51)0.9695
       6-min walk testEstimated meanƒƒ (m)496.5 (465.0–528.0)456.3 (413.2–499.3)Treatment difference###32.51 (−21.2–86.25)0.2383

      AZITHRO: azithromycin; SOC: standard of care; CIF: cumulative incidence functions; HR: hazard ratio; OR: odds ratio; Hosp.: hospitalised; MV: mechanical ventilation; ECMO: extracorporeal membrane oxygenation; KM: Kaplan-Meier; ICU: intensive care unit; NC: not calculated; CT: computed tomography; DLCO: diffusing capacity of the lung for carbon monoxide. #: score >1 favours azithromycin; HR was obtained using a Fine & Gray model for competing risk data including treatment, study site and study period as factors. ¶: event rates were estimated as CIF, taking into account the competing risk of death. +: missing data are accounted for by multiple imputation. §: score >1 favours azithromycin; OR was obtained from a multinomial logistic regression with factors for treatment, disease severity and clinical status on day 0. ƒ: geometric mean was obtained using a general linear model including treatment as factor. ##: score >1 favours SOC; treatment ratio was calculated as the ratio of geometric means, obtained using a general linear model including treatment, study site, study period and clinical status on day 0 as factors (note: data were log-transformed prior to statistical analysis). ¶¶: score >1 favours SOC; HR was obtained using log-rank test after event rates were estimated using Kaplan–Meier methodology. ++: score >1 favours SOC; ORs were obtained using logistic regression including treatment, study site and study period as factors in the model. §§: score >1 favours azithromycin; ORs were obtained using logistic regression including treatment, study site and study period as factors in the model. ƒƒ: obtained using a general linear model including treatment as factor. ###: higher score (>0) favours azithromycin; obtained using a general linear model including treatment, study site and period as factors. ¶¶¶: score >1 favours SOC; HR was obtained using a Fine & Gray model for competing risk data including treatment, study site and study period as factors.

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      Azithromycin for treatment of hospitalised COVID-19 patients: a randomised, multicentre, open-label clinical trial (DAWn-AZITHRO)
      Iwein Gyselinck, Laurens Liesenborghs, Ann Belmans, Matthias M. Engelen, Albrecht Betrains, Quentin Van Thillo, Pham Anh Hong Nguyen, Pieter Goeminne, Ann-Catherine Soenen, Nikolaas De Maeyer, Charles Pilette, Emmanuelle Papleux, Eef Vanderhelst, Aurélie Derweduwen, Patrick Alexander, Bernard Bouckaert, Jean-Benoît Martinot, Lynn Decoster, Kurt Vandeurzen, Rob Schildermans, Peter Verhamme, Wim Janssens, Robin Vos
      ERJ Open Research Jan 2022, 8 (1) 00610-2021; DOI: 10.1183/23120541.00610-2021

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      Azithromycin for treatment of hospitalised COVID-19 patients: a randomised, multicentre, open-label clinical trial (DAWn-AZITHRO)
      Iwein Gyselinck, Laurens Liesenborghs, Ann Belmans, Matthias M. Engelen, Albrecht Betrains, Quentin Van Thillo, Pham Anh Hong Nguyen, Pieter Goeminne, Ann-Catherine Soenen, Nikolaas De Maeyer, Charles Pilette, Emmanuelle Papleux, Eef Vanderhelst, Aurélie Derweduwen, Patrick Alexander, Bernard Bouckaert, Jean-Benoît Martinot, Lynn Decoster, Kurt Vandeurzen, Rob Schildermans, Peter Verhamme, Wim Janssens, Robin Vos
      ERJ Open Research Jan 2022, 8 (1) 00610-2021; DOI: 10.1183/23120541.00610-2021
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