Doxycycline for the prevention of progression of COVID-19 to severe disease requiring intensive care unit (ICU) admission: A randomized, controlled, open-label, parallel group trial (DOXPREVENT.ICU).
<h4>Background</h4>After admission to hospital, COVID-19 progresses in a substantial proportion of patients to critical disease that requires intensive care unit (ICU) admission.<h4>Methods</h4>In a pragmatic, non-blinded trial, 387 patients aged 40-90 years were randomised t...
| Үндсэн зохиолчид: | , , , , , , , , , , , |
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| Формат: | Өгүүллэг |
| Хэл сонгох: | English |
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Public Library of Science (PLoS)
2023-01-01
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| Цуврал: | PLoS ONE |
| Онлайн хандалт: | https://doi.org/10.1371/journal.pone.0280745 |
| _version_ | 1828053959064944640 |
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| author | Raja Dhar John Kirkpatrick Laura Gilbert Arjun Khanna Mahavir Madhavdas Modi Rakesh K Chawla Sonia Dalal Venkata Nagarjuna Maturu Marcel Stern Oliver T Keppler Ratko Djukanovic Stephan D Gadola |
| author_facet | Raja Dhar John Kirkpatrick Laura Gilbert Arjun Khanna Mahavir Madhavdas Modi Rakesh K Chawla Sonia Dalal Venkata Nagarjuna Maturu Marcel Stern Oliver T Keppler Ratko Djukanovic Stephan D Gadola |
| author_sort | Raja Dhar |
| collection | DOAJ |
| description | <h4>Background</h4>After admission to hospital, COVID-19 progresses in a substantial proportion of patients to critical disease that requires intensive care unit (ICU) admission.<h4>Methods</h4>In a pragmatic, non-blinded trial, 387 patients aged 40-90 years were randomised to receive treatment with SoC plus doxycycline (n = 192) or SoC only (n = 195). The primary outcome was the need for ICU admission as judged by the attending physicians. Three types of analyses were carried out for the primary outcome: "Intention to treat" (ITT) based on randomisation; "Per protocol" (PP), excluding patients not treated according to randomisation; and "As treated" (AT), based on actual treatment received. The trial was undertaken in six hospitals in India with high-quality ICU facilities. An online application serving as the electronic case report form was developed to enable screening, randomisation and collection of outcomes data.<h4>Results</h4>Adherence to treatment per protocol was 95.1%. Among all 387 participants, 77 (19.9%) developed critical disease needing ICU admission. In all three primary outcome analyses, doxycycline was associated with a relative risk reduction (RRR) and absolute risk reduction (ARR): ITT 31.6% RRR, 7.4% ARR (P = 0.063); PP 40.7% RRR, 9.6% ARR (P = 0.017); AT 43.2% RRR, 10.8% ARR (P = 0.007), with numbers needed to treat (NTT) of 13.4 (ITT), 10.4 (PP), and 9.3 (AT), respectively. Doxycycline was well tolerated with not a single patient stopping treatment due to adverse events.<h4>Conclusions</h4>In hospitalized COVID-19 patients, doxycycline, a safe, inexpensive, and widely available antibiotic with anti-inflammatory properties, reduces the need for ICU admission when added to SoC. |
| first_indexed | 2024-04-10T20:15:22Z |
| format | Article |
| id | doaj.art-30d33b5ca76b4674aa72c79f6b2bc62d |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-04-10T20:15:22Z |
| publishDate | 2023-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-30d33b5ca76b4674aa72c79f6b2bc62d2023-01-26T05:31:54ZengPublic Library of Science (PLoS)PLoS ONE1932-62032023-01-01181e028074510.1371/journal.pone.0280745Doxycycline for the prevention of progression of COVID-19 to severe disease requiring intensive care unit (ICU) admission: A randomized, controlled, open-label, parallel group trial (DOXPREVENT.ICU).Raja DharJohn KirkpatrickLaura GilbertArjun KhannaMahavir Madhavdas ModiRakesh K ChawlaSonia DalalVenkata Nagarjuna MaturuMarcel SternOliver T KepplerRatko DjukanovicStephan D Gadola<h4>Background</h4>After admission to hospital, COVID-19 progresses in a substantial proportion of patients to critical disease that requires intensive care unit (ICU) admission.<h4>Methods</h4>In a pragmatic, non-blinded trial, 387 patients aged 40-90 years were randomised to receive treatment with SoC plus doxycycline (n = 192) or SoC only (n = 195). The primary outcome was the need for ICU admission as judged by the attending physicians. Three types of analyses were carried out for the primary outcome: "Intention to treat" (ITT) based on randomisation; "Per protocol" (PP), excluding patients not treated according to randomisation; and "As treated" (AT), based on actual treatment received. The trial was undertaken in six hospitals in India with high-quality ICU facilities. An online application serving as the electronic case report form was developed to enable screening, randomisation and collection of outcomes data.<h4>Results</h4>Adherence to treatment per protocol was 95.1%. Among all 387 participants, 77 (19.9%) developed critical disease needing ICU admission. In all three primary outcome analyses, doxycycline was associated with a relative risk reduction (RRR) and absolute risk reduction (ARR): ITT 31.6% RRR, 7.4% ARR (P = 0.063); PP 40.7% RRR, 9.6% ARR (P = 0.017); AT 43.2% RRR, 10.8% ARR (P = 0.007), with numbers needed to treat (NTT) of 13.4 (ITT), 10.4 (PP), and 9.3 (AT), respectively. Doxycycline was well tolerated with not a single patient stopping treatment due to adverse events.<h4>Conclusions</h4>In hospitalized COVID-19 patients, doxycycline, a safe, inexpensive, and widely available antibiotic with anti-inflammatory properties, reduces the need for ICU admission when added to SoC.https://doi.org/10.1371/journal.pone.0280745 |
| spellingShingle | Raja Dhar John Kirkpatrick Laura Gilbert Arjun Khanna Mahavir Madhavdas Modi Rakesh K Chawla Sonia Dalal Venkata Nagarjuna Maturu Marcel Stern Oliver T Keppler Ratko Djukanovic Stephan D Gadola Doxycycline for the prevention of progression of COVID-19 to severe disease requiring intensive care unit (ICU) admission: A randomized, controlled, open-label, parallel group trial (DOXPREVENT.ICU). PLoS ONE |
| title | Doxycycline for the prevention of progression of COVID-19 to severe disease requiring intensive care unit (ICU) admission: A randomized, controlled, open-label, parallel group trial (DOXPREVENT.ICU). |
| title_full | Doxycycline for the prevention of progression of COVID-19 to severe disease requiring intensive care unit (ICU) admission: A randomized, controlled, open-label, parallel group trial (DOXPREVENT.ICU). |
| title_fullStr | Doxycycline for the prevention of progression of COVID-19 to severe disease requiring intensive care unit (ICU) admission: A randomized, controlled, open-label, parallel group trial (DOXPREVENT.ICU). |
| title_full_unstemmed | Doxycycline for the prevention of progression of COVID-19 to severe disease requiring intensive care unit (ICU) admission: A randomized, controlled, open-label, parallel group trial (DOXPREVENT.ICU). |
| title_short | Doxycycline for the prevention of progression of COVID-19 to severe disease requiring intensive care unit (ICU) admission: A randomized, controlled, open-label, parallel group trial (DOXPREVENT.ICU). |
| title_sort | doxycycline for the prevention of progression of covid 19 to severe disease requiring intensive care unit icu admission a randomized controlled open label parallel group trial doxprevent icu |
| url | https://doi.org/10.1371/journal.pone.0280745 |
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