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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; DOI: 10.1183/23120541.00610-2021
Iwein Gyselinck
1Department 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, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU 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
4Department of Cardiovascular Diseases, UZ Leuven and Centre for Molecular and Vascular Biology, KU Leuven, Leuven, Belgium
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Albrecht Betrains
5Department of General Internal Medicine, University Hospitals Leuven and Department of Microbiology, Immunology, and Transplantation, KU Leuven, Leuven, Belgium
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Quentin Van Thillo
6Center for Cancer Biology, Vlaams Instituut voor Biotechnologie (VIB), Leuven and Center for Human Genetics, KU Leuven, Leuven, Belgium
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Pham Anh Hong Nguyen
7Department of Respiratory Diseases, Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium
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Pieter Goeminne
8Department of Respiratory Diseases, AZ Nikolaas, Sint-Niklaas, Belgium
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Ann-Catherine Soenen
9Department of Respiratory Diseases, Jan Yperman Ziekenhuis, Ypres, Belgium
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Nikolaas De Maeyer
10Department of Respiratory Diseases, Heilig Hart Ziekenhuis, Leuven, Belgium
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Charles Pilette
11Department of Respiratory Diseases, Cliniques Universitaires Saint-Luc, Brussels, Belgium
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Emmanuelle Papleux
12Department of Respiratory Diseases, Hôpitaux Iris Sud, Brussels, Belgium
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Eef Vanderhelst
13Department of Respiratory Diseases, University Hospital UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium
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Aurélie Derweduwen
14Department of Respiratory Diseases, AZ klina, Brasschaat, Belgium
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Patrick Alexander
15Department of Respiratory Diseases, AZ Glorieux, Ronse, Belgium
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Bernard Bouckaert
16Department of Respiratory Diseases, AZ Delta, Roeselare, Belgium
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Jean-Benoît Martinot
17Department of Respiratory Diseases, Centre Hospitalier Universitaire-UC Louvain, Namur, Belgium
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Lynn Decoster
18Department of Respiratory Diseases, AZ Turnhout, Turnhout, Belgium
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Kurt Vandeurzen
19Department of Respiratory Diseases, Mariaziekenhuis Noord Limburg, Pelt, Belgium
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Rob Schildermans
20Department of Respiratory Diseases, AZ Sint Lucas, Bruges, Belgium
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Peter Verhamme
21Department of Cardiovascular Diseases, UZ Leuven and Centre for Molecular and Vascular Biology, KU Leuven, Leuven, Belgium
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Wim Janssens
1Department of Respiratory Diseases, UZ Leuven and CHROMETA, Research group BREATHE, KU Leuven, Leuven, Belgium
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Robin Vos
1Department of Respiratory Diseases, UZ Leuven and CHROMETA, Research group BREATHE, KU Leuven, Leuven, Belgium
22The DAWn-azithro investigators are: Van Assche Thomas, Devos Timothy, Meyfroidt Geert, Ceunen Helga, Debaveye Barbara, ‘t Lam Maylorie, Haesendonck Kaat, Goegebeur Lies, Neyts Johan, Van Wijngaerden Eric, De Munter Paul
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  • FIGURE 1
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    FIGURE 1

    Primary Endpoint: Cumulative Incidence Function of Sustained Clinical Improvement or Live Discharge (FAS).

  • FIGURE 2
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    FIGURE 2

    Forest Plot Subgroup analyses for Primary Endpoint: Time to Sustained Clinical Improvement or Discharge (FAS).

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    FIGURE 3

    Bar Chart of Daily Clinical Status (FAS).

Tables

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  • TABLE 1

    Subject Disposition & Baseline Information (FAS/SS)

    Full Analysis Set=Safety SetStatisticAZITHRO + SOCSOCTotal
    Total Number of PatientsN11964183
    Demographics
     Age [y]Mean (SD)63 (15)59 (15)62 (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 African 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%)
      Ischemic 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/min)n/N (%)57/119 (47.90%)33/ 61 (54.10%)90/180 (50.00%)
      Respiratory Support within First 2 Hours
    -­ 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 non-invasive 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 non-invasive ventilationn/N (%)9/119 (7.56%)5/64 (7.81%)14/183 (7.65%)
    6. Hosp., on inv. 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] Ref. ≤ 5Median (Q1; Q3)73.8 (35.2; 125.8)59.5 (23.5; 93.3)68.0 (33.1; 119.2)
     WBC [109/L]Ref. 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/L]Ref. 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/L]Ref. 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]Ref. 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]Ref. ≤ 500Median (Q1; Q3)743.0 (466.0; 1174.0)670.0 (378.0; 958.0)723.5 (455.5; 1160.0)
     Fibrinogen [g/L]Ref. 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]Ref. ≥ 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 (SD)[111] 418.9 (25.3)[57] 416.5 (28.6)[168] 418.1 (26.4)
    Symptom onset
     Time from Symptom Onset to Randomisation [days]Median (Q1; Q3)7 (4; 10)7 (5; 10)7 (5; 10)
    • Abbreviations: Ref: reference value, CRP: C-reactive protein, WBC: white blood cell count.

  • TABLE 2

    Trial Primary and Secondary Endpoints – 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 suppl. oxygen7/97 (7.22%)2/53 (3.77%)
    4. Hosp., requiring oxygen10/97 (10.31%)4/53 (7.55%)
    5. Hosp., NIV5/97 (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 meanΣ42.61 (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%)Hazard Ratio◊1.799 (0.201; 16.09)0.5996
    -­ 29-daysKM (%)7.6% (4.0%; 14.0%)6.5% (2.5%; 16.3%)Hazard Ratio◊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 hospital discharge*
    -­ Occurrence of live hospital dischargeCIF# (%)85.8% (78.0%; 91.0%)84.4% (72.5%; 91.4%)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 endpoint (hs-Troponin >0.5 ng/ml and/or ventricular arrhythmia requiring intervention and/or sudden cardiac death)n/N (%)24/119 (20.17%)12/64 (18.75%)Odds Ratio¥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%)Odds Ratio‡1.56 (0.64;3.79)0.3233
     DLCO (% predicted)Estimated meanΩ (%)66.49 (59.96; 73.02)67.00 (57.91; 76.09)Treatment difference###0.22 (−11.1; 11.51)0.9695
     6-min walking testEstimated meanΩ (meters)496.5 (465.0; 528.0)456.3 (413.2; 499.3)Treatment difference###32.51 (−21.2; 86.25)0.2383
    • Abbreviations: NIV: non-invasive ventilation, MV: mechanical ventilation, ECMO: extracorporeal membrane oxygenation.

    • #Event rates were estimated as cumulative incidence functions (CIF), taking into account the competing risk of death.

    • *Score>1 favours azithromycin. Hazard ratio was obtained using a Fine & Gray model for competing risk data including treatment, study site and study period as factors.

    • $Score>1 favours azithromycin. Odds ratio was obtained from a multinomial logistic regression with factors for treatment, disease severity and Clinical Status on Day 0.

    • ΣGeometric 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. (Notes: Data were log-transformed prior to statistical analysis).

    • †Score>1 favours SOC. Hazard ratio was obtained using a Fine & Gray model for competing risk data including treatment, study site and study period as factors.

    • ◊Score>1 favours SOC. Hazard ratio was obtained using Log-Rank test after event rates were estimated using Kaplan-Meier methodology.

    • ‡Score>1 favours azithromycin. Odds ratios were obtained using logistic regression including treatment, study site and study period as factors in the model.

    • ¥Score>1 favours SOC. Odds ratios were obtained using logistic regression including treatment, study site and study period as factors in the model.

    • ΩObtained using a general linear model including treatment as factor.

    • ΔScore>1 favours SOC. Hazard ratio was obtained using a Fine & Gray model for competing risk data including treatment, study site and study period as factors

    • ###Higher score (> 0) favours azithromycin. Obtained using a general linear model including treatment, study site and period as factors.

    • **Missing data are accounted for by multiple imputation.

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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 Jan 2022, 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, for the DAWn-AZITHRO investigators
ERJ Open Research Jan 2022, 00610-2021; DOI: 10.1183/23120541.00610-2021
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