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

Covid19 Clinical Trial

— O2CoV2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04918875
• Other study ID #: CERC.0040
• Status: Active, not recruiting
• Start date: January 1, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: August 2023
• Source: World Health Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2400
• Est. completion date: October 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Covid19

Locations

Country	Name	City	State
Switzerland	World Health Organization	Geneva	Other

Sponsors (1)

Lead Sponsor	Collaborator
Pryanka Relan

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Proportion of patients progressing to invasive mechanical ventilation	If available at facility	Over first 7 days of hospitalization
Primary	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	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.
Secondary	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