Oxygen Requirements and Use in Patients With COVID-19 in LMICs

Study Overview
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Brief Summary
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This observational cohort study will enroll patients in LMICs with suspected or confirmed COVID-19 on oxygen or deemed to require oxygen therapy based on objective criteria. Demographics and risk factor information will be collected from participants. Participants will be followed for 7 days or until outcome (hospital discharge or death). Facility level metrics on oxygen availability will also be collected at the beginning of site enrolment.

Detailed Description
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The COVID-19 pandemic has highlighted, more than ever, the acute need for scale up of oxygen therapy. WHO has provided an inventory tool to quantify facility-level provision of infrastructure to deliver oxygen therapy. However, data on the use of oxygen therapy at the patient-level remains lacking. This observational cohort study will enroll patients in LMICs with suspected or confirmed COVID-19 on oxygen or deemed to require oxygen therapy based on objective criteria. Demographics and risk factor information will be collected from participants. Participants will be followed for 7 days or until outcome (hospital discharge or death). Facility level metrics on oxygen availability will also be collected at the beginning of site enrolment.

Official Title
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Oxygen Requirements and Approaches to Respiratory Support in Patients With COVID-19 in LMICs: A WHO Study

Conditions
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Covid19, COVID-19 Pneumonia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspected SARS-CoV-2 infection as determined by treating clinical provider, or confirmed SARS-CoV-2 infection confirmed virologically in the lab by RT-PCR via nasopharyngeal or oropharyngeal sample or by SARS-CoV-2 Ag-RDTs that meet the minimum performance requirements of ≥80% sensitivity and ≥97% specificity compared to a NAAT reference assay. Receiving supplemental oxygen or showing clinical evidence of need for supplemental respiratory support as reflected in a respiratory rate ≥30 breaths per minute or an SpO2 ≤ 90%, SpO2 < 94 % if any emergency signs are present Admitted to health care facility Exclusion Criteria: Is not receiving oxygen or does not have clinical criteria for oxygen treatment specified above oxygen therapy Does not have suspected or confirmed COVID-19 (as per criteria above) Patient younger than 12 years of age Lack of commitment to full supportive care

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients 12 years of age or older with suspected or confirmed COVID-19, deemed to require oxygen.<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients receiving oxygen via each of various delivery devices. | Oxygen delivery devices analysed: nasal cannulae, face mask, Venturi, NRB, HFNO, CPAP, NIV, IMV | Over first 7 days of hospitalization | 
| Proportion of patients progressing to invasive mechanical ventilation | If available at facility | Over first 7 days of hospitalization | 
| Total oxygen requirements in patients receiving oxygen via each of various delivery devices. | Daily oxygen use measured in liters. For nasal cannula, facemask, and non-rebreather FiO2 is assumed to be 1.0 and flow rates are adjustable in liters per minute. Liter per day consumption of O2 = device flow rate L/minute x 60 minutes/hr x 24 hr/day For high flow nasal cannula FiO2 is adjustable (defaulted to 1.0) and flow rate is adjustable in liters per minute. Liter per day consumption of O2 = device flow rate L/minute x 60 minutes/hr x 24 hr/day; flow rate in LPM = device flow rate x (FiO2 - 0.21)/0.79 For ventilator, CPAP, BIPAP/NIPPV FiO2 is adjustable (defaulted to 1.0) and flow rate is adjustable in liters per minute and dependent on multiple factors. Liter per day consumption of O2 = device O2 consumption rate L/minute x 60 minutes/hr x 24 hr/day Device O2 consumption rate in LPM = (Minute ventilation + (bias flow x RR x expiratory time/60) + leak) x (FiO2 - 0.21)/0.79 | Over first 7 days of hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics and outcomes at hospital discharge of cohort of hospitalized patients | Baseline characteristics, daily parameters over 7 days, hospital outcomes | Until patient discharge from hospital or death, censored at 30 days. | 
| Quantification of total oxygen supply at each facility | Description of oxygen source, distribution and biomedical equipment at facility level and estimated oxygen capacity at the facility level | One time at beginning of enrolment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxygen, covid-19