Clinical trial NCT04918875: Oxygen Requirements and Use in Patients With COVID-19 in LMICs
Official title: Oxygen Requirements and Approaches to Respiratory Support in Patients With COVID-19 in LMICs: A WHO Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Covid19
COVID-19 Pneumonia
Keywords: oxygen
covid-19
Lead sponsor: World Health Organization
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 2400
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who access emergency unit/department (if available) or anywhere acutely ill patients are first assessed.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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
3. Admitted to health care facility

Exclusion Criteria:

1. Is not receiving oxygen or does not have clinical criteria for oxygen treatment specified above oxygen therapy
2. Does not have suspected or confirmed COVID-19 (as per criteria above)
3. Patient younger than 12 years of age
4. Lack of commitment to full supportive care

Primary outcomes:
measure: Proportion of patients receiving oxygen via each of various delivery devices.
timeFrame: Over first 7 days of hospitalization
measure: Proportion of patients progressing to invasive mechanical ventilation
timeFrame: Over first 7 days of hospitalization
measure: Total oxygen requirements in patients receiving oxygen via each of various delivery devices.
timeFrame: Over first 7 days of hospitalization
Secondary outcomes:
measure: Demographics and outcomes at hospital discharge of cohort of hospitalized patients
timeFrame: Until patient discharge from hospital or death, censored at 30 days.
measure: Quantification of total oxygen supply at each facility
timeFrame: One time at beginning of enrolment
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: World Health Organization
state: Other
Study officials:
affiliation: World Health Organization
name: WHO
role: STUDY_DIRECTOR
References: