Oxygen Requirements and Use in Patients With COVID-19 in LMICs (O2CoV2)

Pryanka Relan

Status: Active, not recruiting

Conditions: COVID-19 Pneumonia; Covid19

Study type: Observational

Funder types: Other

Identifiers

NCT04918875

CERC.0040

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,400 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,400 participants in 1 patient group

Patients 12 years of age or older with suspected or confirmed COVID-19, deemed to require oxygen.