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

NCT04918875 | Unknown

• 1 other identifier: CERC.0040
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; COVID-19 Pneumonia

Keywords

oxygen; covid-19

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Demographics and outcomes at hospital discharge of cohort of hospitalized patients

  Until patient discharge from hospital or death, censored at 30 days.

• Quantification of total oxygen supply at each facility

  One time at beginning of enrolment

Study Arms (1)

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

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who access emergency unit/department (if available) or anywhere acutely ill patients are first assessed.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pryanka Relan: lead

Study Sites (1)

World Health Organization

Geneva, Other, 1202, Switzerland

Location

Related Publications (2)

• Relan P, Rylance J, Arabi YM, Convocar P, Rolland M, Diaz JV; O2CoV2 investigators. Medical oxygen and respiratory support requirements for patients hospitalised with COVID-19 in 23 low-income and middle-income countries: a prospective, observational cohort study. Lancet Glob Health. 2026 Feb;14(2):e233-e241. doi: 10.1016/S2214-109X(25)00480-2.

  PMID: 41519152 DERIVED

• Relan P, Murthy S, Marshall JC, Annane D, Chevret S, Arabi YM, Waweru-Siika W, Dominguez Rodriguez S, Convocar P, Diaz J; World Health Organization Respiratory Support Research Group; World Health Organization O2CoV2 International Study Steering Committee. 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. BMJ Open. 2023 Aug 17;13(8):e071346. doi: 10.1136/bmjopen-2022-071346.

  PMID: 37591648 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• WHO

  World Health Organization

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Technical officer

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 9, 2021
• Study Start: January 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: October 30, 2023
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)