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

Sponsor

Pryanka Relan (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04918875

Collaborator

(none)

2,400

Enrollment

Location

10.6

Anticipated Duration (Months)

225.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 COVID-19 Pneumonia

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

2400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 25, 2022

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Dec 15, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Proportion of patients receiving oxygen via each of various delivery devices. [Over first 7 days of hospitalization]
Oxygen delivery devices analysed: nasal cannulae, face mask, Venturi, NRB, HFNO, CPAP, NIV, IMV
Proportion of patients progressing to invasive mechanical ventilation [Over first 7 days of hospitalization]
If available at facility
Total oxygen requirements in patients receiving oxygen via each of various delivery devices. [Over first 7 days of hospitalization]
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	World Health Organization	Geneva	Other	Switzerland	1202

Sponsors and Collaborators

Pryanka Relan

Investigators

Study Director: WHO, World Health Organization

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pryanka Relan, Technical officer, World Health Organization

ClinicalTrials.gov Identifier:

NCT04918875

Other Study ID Numbers:

CERC.0040

First Posted:

Jun 9, 2021

Last Update Posted:

Apr 27, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pryanka Relan, Technical officer, World Health Organization

oxygen

covid-19

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Apr 27, 2022