Covid19O2CoV2NCT04918875
Oxygen Requirements and Use in Patients With COVID-19 in LMICs
An observational study of Covid19 and COVID-19 Pneumonia, run by Pryanka Relan at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Covid19, COVID-19 Pneumonia
- How many people
- 2,400 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2022to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who access emergency unit/department (if available) or anywhere acutely ill patients are first assessed.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oxygen Requirements and Approaches to Respiratory Support in Patients With COVID-19 in LMICs: A WHO Study
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.
Read the 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.
- Conditions
- Covid19, COVID-19 Pneumonia
- Keywords
- oxygen, covid-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients 12 years of age or older with suspected or confirmed COVID-19, deemed to require oxygen. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Over first 7 days of hospitalization
Proportion of patients progressing to invasive mechanical ventilation
If available at facility
Measured: 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
Measured: Over first 7 days of hospitalization
Secondary outcomes (2)
Demographics and outcomes at hospital discharge of cohort of hospitalized patients
Baseline characteristics, daily parameters over 7 days, hospital outcomes
Measured: Until patient discharge from hospital or death, censored at 30 days.
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
Measured: One time at beginning of enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start1 Jan 2022
- Primary completion30 Apr 2023
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pryanka Relan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pryanka Relan, World Health Organization
- Investigators
- WHO, Study director, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918875
- Sponsor's protocol ID
- CERC.0040
- Acronym
- O2CoV2
- Status last verified
- Aug 2023
- First submitted
- 31 May 2021
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41519152Relan 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.
PubMed 37591648
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Requirements and Approaches to Respiratory Support in Patients With COVID-19 in LMICs: A WHO Study
- ClinicalTrials.gov ID
- NCT04918875
- Acronym / sponsor ID
- O2CoV2 / CERC.0040
- Conditions
- Covid19, COVID-19 Pneumonia
- Keywords
- oxygen, covid-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Pryanka RelanUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients 12 years of age or older with suspected or confirmed COVID-19, deemed to require oxygen. | – | – |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who access emergency unit/department (if available) or anywhere acutely ill patients are first assessed.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Proportion of patients progressing to invasive mechanical ventilation
Time frame: Over first 7 days of hospitalization
If available at facility
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
2 secondary outcomes
Demographics and outcomes at hospital discharge of cohort of hospitalized patients
Time frame: Until patient discharge from hospital or death, censored at 30 days.
Quantification of total oxygen supply at each facility
Time frame: One time at beginning of enrolment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Derived from this study: PubMed 41519152Relan 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.
- Derived from this study: PubMed 37591648Relan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WHO study director
World Health Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and COVID-19 Pneumonia, run by Pryanka Relan at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients receiving oxygen via each of various delivery devices. (time frame: Over first 7 days of hospitalization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04918875, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.