WHO O2CoV2 : oxygen requirements and respiratory support in patients with COVID-19 in low-and-middle income countries-protocol for a multicountry, prospective, observational cohort study
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ..
INTRODUCTION: SARS-CoV-2 has been identified as the cause of the disease officially named COVID-19, primarily a respiratory illness. COVID-19 was characterised as a pandemic on 11 March 2020. It has been estimated that approximately 20% of people with COVID-19 require oxygen therapy. Oxygen has been listed on the WHO Model List of Essential Medicines List and Essential Medicines List for Children for almost two decades. The COVID-19 pandemic has highlighted, more than ever, the acute need for scale-up of oxygen therapy. Detailed data on the use of oxygen therapy in low-and-middle income countries at the patient and facility level are needed to target interventions better globally.
METHODS AND ANALYSIS: We aim to describe the requirements and use of oxygen at the facility and patient level of approximately 4500 patients with COVID-19 in 30 countries. Our objectives are specifically to characterise type and duration of different modalities of oxygen therapy delivered to patients; describe demographics and outcomes of hospitalised patients with COVID-19; and describe facility-level oxygen production and support. Primary analyses will be descriptive in nature. Respiratory support transitions will be described in Sankey plots, and Kaplan-Meier models will be used to estimate probability of each transition. A multistate model will be used to study the course of hospital stay of the study population, evaluating transitions of escalating respiratory support transitions to the absorbing states.
ETHICS AND DISSEMINATION: WHO Ad Hoc COVID-19 Research Ethics Review Committee (ERC) has approved this global protocol. When this protocol is adopted at specific country sites, national ERCs may make require adjustments in accordance with their respective national research ethics guidelines. Dissemination of this protocol and global findings will be open access through peer-reviewed scientific journals, study website, press and online media.
TRIAL REGISTRATION NUMBER: NCT04918875.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
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| Enthalten in: |
BMJ open - 13(2023), 8 vom: 17. Aug., Seite e071346 |
| Sprache: |
Englisch |
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| Links: |
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| Themen: |
ACCIDENT & EMERGENCY MEDICINE |
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| Anmerkungen: |
Date Completed 21.08.2023 Date Revised 14.12.2023 published: Electronic ClinicalTrials.gov: NCT04918875 Citation Status MEDLINE |
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| doi: |
10.1136/bmjopen-2022-071346 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 500 | |a Date Revised 14.12.2023 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04918875 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a INTRODUCTION: SARS-CoV-2 has been identified as the cause of the disease officially named COVID-19, primarily a respiratory illness. COVID-19 was characterised as a pandemic on 11 March 2020. It has been estimated that approximately 20% of people with COVID-19 require oxygen therapy. Oxygen has been listed on the WHO Model List of Essential Medicines List and Essential Medicines List for Children for almost two decades. The COVID-19 pandemic has highlighted, more than ever, the acute need for scale-up of oxygen therapy. Detailed data on the use of oxygen therapy in low-and-middle income countries at the patient and facility level are needed to target interventions better globally | ||
| 520 | |a METHODS AND ANALYSIS: We aim to describe the requirements and use of oxygen at the facility and patient level of approximately 4500 patients with COVID-19 in 30 countries. Our objectives are specifically to characterise type and duration of different modalities of oxygen therapy delivered to patients; describe demographics and outcomes of hospitalised patients with COVID-19; and describe facility-level oxygen production and support. Primary analyses will be descriptive in nature. Respiratory support transitions will be described in Sankey plots, and Kaplan-Meier models will be used to estimate probability of each transition. A multistate model will be used to study the course of hospital stay of the study population, evaluating transitions of escalating respiratory support transitions to the absorbing states | ||
| 520 | |a ETHICS AND DISSEMINATION: WHO Ad Hoc COVID-19 Research Ethics Review Committee (ERC) has approved this global protocol. When this protocol is adopted at specific country sites, national ERCs may make require adjustments in accordance with their respective national research ethics guidelines. Dissemination of this protocol and global findings will be open access through peer-reviewed scientific journals, study website, press and online media | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT04918875 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a ACCIDENT & EMERGENCY MEDICINE | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a Health policy | |
| 650 | 4 | |a INTENSIVE & CRITICAL CARE | |
| 650 | 4 | |a Protocols & guidelines | |
| 650 | 4 | |a RESPIRATORY MEDICINE (see Thoracic Medicine) | |
| 650 | 7 | |a Oxygen |2 NLM | |
| 650 | 7 | |a S88TT14065 |2 NLM | |
| 700 | 1 | |a Murthy, Srinivas |e verfasserin |4 aut | |
| 700 | 1 | |a Marshall, John C |e verfasserin |4 aut | |
| 700 | 1 | |a Annane, Djillali |e verfasserin |4 aut | |
| 700 | 1 | |a Chevret, Sylvie |e verfasserin |4 aut | |
| 700 | 1 | |a Arabi, Yaseen M |e verfasserin |4 aut | |
| 700 | 1 | |a Waweru-Siika, Wangari |e verfasserin |4 aut | |
| 700 | 1 | |a Dominguez Rodriguez, Sara |e verfasserin |4 aut | |
| 700 | 1 | |a Convocar, Pauline |e verfasserin |4 aut | |
| 700 | 1 | |a Diaz, Janet |e verfasserin |4 aut | |
| 700 | 0 | |a World Health Organization Respiratory Support Research Group |e verfasserin |4 aut | |
| 700 | 0 | |a World Health Organization O2CoV2 International Study Steering Committee |e verfasserin |4 aut | |
| 700 | 1 | |a Adhikari, Neill |e investigator |4 oth | |
| 700 | 1 | |a Aryal, Diptesh |e investigator |4 oth | |
| 700 | 1 | |a Baker, Tim |e investigator |4 oth | |
| 700 | 1 | |a Christopher, Devasahayam J |e investigator |4 oth | |
| 700 | 1 | |a Fowler, Rob |e investigator |4 oth | |
| 700 | 1 | |a Gartley, Martha |e investigator |4 oth | |
| 700 | 1 | |a Goligher, Ewan |e investigator |4 oth | |
| 700 | 1 | |a Haniffa, Rashan |e investigator |4 oth | |
| 700 | 1 | |a Jayakumar, Devachandran |e investigator |4 oth | |
| 700 | 1 | |a Kallet, Richard H |e investigator |4 oth | |
| 700 | 1 | |a Kojan, Richard |e investigator |4 oth | |
| 700 | 1 | |a Kwizera, Arthur |e investigator |4 oth | |
| 700 | 1 | |a Li, Jie |e investigator |4 oth | |
| 700 | 1 | |a Mekontso-Dessap, Armand |e investigator |4 oth | |
| 700 | 1 | |a Paletta, Christian |e investigator |4 oth | |
| 700 | 1 | |a Rendon, Ingrid Lara |e investigator |4 oth | |
| 700 | 1 | |a Riviello, Elisabeth |e investigator |4 oth | |
| 700 | 1 | |a Salluh, Jorge |e investigator |4 oth | |
| 700 | 1 | |a Sterne, Jonathan Ac |e investigator |4 oth | |
| 700 | 1 | |a Tomazini, Bruno Martins |e investigator |4 oth | |
| 700 | 1 | |a Vijayaraghavan, Bharath Kumar Tirupakuzhi |e investigator |4 oth | |
| 700 | 1 | |a Zampieri, Fernando |e investigator |4 oth | |
| 700 | 1 | |a Amrahli, Gasim |e investigator |4 oth | |
| 700 | 1 | |a Appiah, John |e investigator |4 oth | |
| 700 | 1 | |a Aryal, Diptesh |e investigator |4 oth | |
| 700 | 1 | |a Batra, Neale |e investigator |4 oth | |
| 700 | 1 | |a Bligh, Kieran |e investigator |4 oth | |
| 700 | 1 | |a Christopher, Devasahayam J |e investigator |4 oth | |
| 700 | 1 | |a Derow, Mohammed |e investigator |4 oth | |
| 700 | 1 | |a Gaitan, Laura Alejandra Velez Ruiz |e investigator |4 oth | |
| 700 | 1 | |a Garcia, Itziar Carrasco |e investigator |4 oth | |
| 700 | 1 | |a Griffith, Bridget |e investigator |4 oth | |
| 700 | 1 | |a Guitton, Christophe |e investigator |4 oth | |
| 700 | 1 | |a Hashmi, Madiha |e investigator |4 oth | |
| 700 | 1 | |a Kamara, Rashidatu |e investigator |4 oth | |
| 700 | 1 | |a Kawano-Dourado, Leticia |e investigator |4 oth | |
| 700 | 1 | |a Kodama, Chiori |e investigator |4 oth | |
| 700 | 1 | |a Kojan, Richard |e investigator |4 oth | |
| 700 | 1 | |a Kuniyoshi, Gary |e investigator |4 oth | |
| 700 | 1 | |a Kwizera, Arthur |e investigator |4 oth | |
| 700 | 1 | |a Mendes, Maria |e investigator |4 oth | |
| 700 | 1 | |a Pfeifer, Dina |e investigator |4 oth | |
| 700 | 1 | |a Procopio, Cinzia DeBrito |e investigator |4 oth | |
| 700 | 1 | |a Rendon, Ingrid Lara |e investigator |4 oth | |
| 700 | 1 | |a Reveiz, Ludovic |e investigator |4 oth | |
| 700 | 1 | |a Riviello, Elisabeth |e investigator |4 oth | |
| 700 | 1 | |a Rolland, Matthieu |e investigator |4 oth | |
| 700 | 1 | |a Seck, Amadou |e investigator |4 oth | |
| 700 | 1 | |a Stanway, Elizabeth |e investigator |4 oth | |
| 700 | 1 | |a Viry, Julie |e investigator |4 oth | |
| 700 | 1 | |a Wijesinghe, Pushpa |e investigator |4 oth | |
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