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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04918875
Recruitment Status : Active, not recruiting
First Posted : June 9, 2021
Last Update Posted : August 23, 2023
Sponsor:
Information provided by (Responsible Party):
Pryanka Relan, World Health Organization

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
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.

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Study Type : Observational
Estimated 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 : January 1, 2022
Actual Primary Completion Date : April 30, 2023
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Proportion of patients receiving oxygen via each of various delivery devices. [ Time Frame: Over first 7 days of hospitalization ]
    Oxygen delivery devices analysed: nasal cannulae, face mask, Venturi, NRB, HFNO, CPAP, NIV, IMV

  2. Proportion of patients progressing to invasive mechanical ventilation [ Time Frame: Over first 7 days of hospitalization ]
    If available at facility

  3. Total oxygen requirements in patients receiving oxygen via each of various delivery devices. [ Time Frame: 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 :
  1. Demographics and outcomes at hospital discharge of cohort of hospitalized patients [ Time Frame: Until patient discharge from hospital or death, censored at 30 days. ]
    Baseline characteristics, daily parameters over 7 days, hospital outcomes

  2. Quantification of total oxygen supply at each facility [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who access emergency unit/department (if available) or anywhere acutely ill patients are first assessed.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04918875


Locations
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Switzerland
World Health Organization
Geneva, Other, Switzerland, 1202
Sponsors and Collaborators
Pryanka Relan
Investigators
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Study Director: WHO World Health Organization
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Responsible Party: Pryanka Relan, Technical officer, World Health Organization
ClinicalTrials.gov Identifier: NCT04918875    
Other Study ID Numbers: CERC.0040
First Posted: June 9, 2021    Key Record Dates
Last Update Posted: August 23, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pryanka Relan, World Health Organization:
oxygen
covid-19
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases