Coronavirus Disease-2019SOTSPCNCT04312100
Sequential Oxygen Therapy Strategy for Patients With COVID-19
An observational study of Coronavirus Disease-2019, run by Henan Provincial People's Hospital at 1 site in China.
Trial summary
All patients with COVID-19 were divided into three groups according to their illness: mild patient who receive conventional oxygen therapy, severe patients who receive nasal high flow oxygen inhalation or non-invasive positive pressure ventilation，all the oxygen therapy will be used as part of the standard of care. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronavirus Disease-2019
- What is being tested?
- oxygen treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to Feb 2021
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Only patients diagnosed with COVID-19 will be enrolled, diagnosis will depend on RT-PRC provided by China CDC
Who may be able to join
- Patients diagnosed with COVID-19
- Aged between 18-75 years;
- Willing to sign the informed consent voluntarily.
Who cannot join
- Patients with active tuberculosis, idiopathic pulmonary fibrosis, bronchial asthma, bronchiectasis, pulmonary embolism, chronic respiratory failure or other serious respiratory diseases; ② patients with serious cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina, acute myocardial infarction, cardiac function grade 3 or above, stroke, cerebral hemorrhage, etc.); ③ Patients with serious hepatorenal diseases (serious liver diseases refer to cirrhosis, portal hypertension and varicose bleeding, and serious kidney diseases include dialysis and kidney transplantation); ④ tumor patients who have undergone resection, radiotherapy and chemotherapy within 5 years; ⑤ patients who have difficulty in activity due to neuromuscular diseases; ⑥ patients with serious arthritis; ⑦ patients with serious peripheral vascular diseases; ⑧ Pregnant and lactating women; ⑨ with severe cognitive and mental disorders; ⑩ the clinical researchers who were participating in other interventions within one month before selection;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
Li Li, Master, +86-13619842879, sykyxmbgs@163.com
About this study
All patients with COVID-19 were divided into three groups according to their illness: mild patient who receive conventional oxygen therapy, severe patients who receive nasal high flow oxygen inhalation or non-invasive positive pressure ventilation，all the oxygen therapy will be used as part of the standard of care. Each group will enroll 10 patients, the treatment of all patients will be continuously optimized during observation, and the incidence of respiratory failure, intubation rate, 28 day mortality rate, ICU hospitalization days, etc will be recorded and analyzed so to optimize the treatment time window of sequential oxygen therapy
- Conditions
- Coronavirus Disease-2019
- Being tested
- oxygen treatment
- Keywords
- SARS-CoV-2, COVID-19, oxygen treatment
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygen treatmentOther
different kinds of oxygen treatments will be given to patients according to their state of illness
| Study group | Role | What they receive |
|---|---|---|
| Mild cases with conventional oxygen therapy | COVID-19 patients who were considered mild cases will receive conventional oxygen therapy in addition to standard treatment Receives: Other: oxygen treatment | |
| Moderate/Severe cases with nasal high flow oxygen inhalation | COVID-19 patients who were considered Moderate/Severe cases will receive nasal high flow oxygen inhalation in addition to standard treatment Receives: Other: oxygen treatment | |
| Moderate/Severe cases with non-invasive ventilation | COVID-19 patients who were considered Moderate/Severe cases will receive non-invasive positive pressure ventilation in addition to standard treatment Receives: Other: oxygen treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of respiratory failure
Incidence of respiratory failure at day 28 after enrollment
Measured: 28 day
Secondary outcomes (1)
28 day mortality rate
mortality rate at day 28 after enrollment
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start1 Feb 2020
- Primary completionOct 2020 (estimated)
- Study completionFeb 2021 (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 Coronavirus Disease-2019Studies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoju Zhang, PhD, Principal investigator, Henan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312100
- Sponsor's protocol ID
- SOT-C
- Acronym
- SOTSPC
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan JF, Lau SK, To KK, Cheng VC, Woo PC, Yuen KY. Middle East respiratory syndrome coronavirus: another zoonotic betacoronavirus causing SARS-like disease. Clin Microbiol Rev. 2015 Apr;28(2):465-522. doi: 10.1128/CMR.00102-14.
PubMed 25810418Wu P, Hao X, Lau EHY, Wong JY, Leung KSM, Wu JT, Cowling BJ, Leung GM. Real-time tentative assessment of the epidemiological characteristics of novel coronavirus infections in Wuhan, China, as at 22 January 2020. Euro Surveill. 2020 Jan;25(3):2000044. doi: 10.2807/1560-7917.ES.2020.25.3.2000044.
PubMed 31992388
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Oxygen Therapy Strategy for Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04312100
- Acronym / sponsor ID
- SOTSPC / SOT-C
- Conditions
- Coronavirus Disease-2019
- Keywords
- SARS-CoV-2, COVID-19, oxygen treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 18 Mar 2020 (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.
All patients with COVID-19 were divided into three groups according to their illness: mild patient who receive conventional oxygen therapy, severe patients who receive nasal high flow oxygen inhalation or non-invasive positive pressure ventilation，all the oxygen therapy will be used as part of the standard of care. Each group will enroll 10 patients, the treatment of all patients will be continuously optimized during observation, and the incidence of respiratory failure, intubation rate, 28 day mortality rate, ICU hospitalization days, etc will be recorded and analyzed so to optimize the treatment time window of sequential oxygen therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild cases with conventional oxygen therapy | – | Other: oxygen treatmentCOVID-19 patients who were considered mild cases will receive conventional oxygen therapy in addition to standard treatment |
| Moderate/Severe cases with nasal high flow oxygen inhalation | – | Other: oxygen treatmentCOVID-19 patients who were considered Moderate/Severe cases will receive nasal high flow oxygen inhalation in addition to standard treatment |
| Moderate/Severe cases with non-invasive ventilation | – | Other: oxygen treatmentCOVID-19 patients who were considered Moderate/Severe cases will receive non-invasive positive pressure ventilation in addition to standard treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Only patients diagnosed with COVID-19 will be enrolled, diagnosis will depend on RT-PRC provided by China CDC
Key inclusion criteria (3 listed)
- Patients diagnosed with COVID-19
Key exclusion criteria (1 listed)
- Patients with active tuberculosis, idiopathic pulmonary fibrosis, bronchial asthma, bronchiectasis, pulmonary embolism, chronic respiratory failure or other serious respiratory diseases; ② patients with serious cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina, acute myocardial infarction, cardiac function grade 3 or above, stroke, cerebral hemorrhage, etc.); ③ Patients with serious hepatorenal diseases (serious liver diseases refer to cirrhosis, portal hypertension and varicose bleeding, and serious kidney diseases include dialysis and kidney transplantation); ④ tumor patients who have undergone resection, radiotherapy and chemotherapy within 5 years; ⑤ patients who have difficulty in activity due to neuromuscular diseases; ⑥ patients with serious arthritis; ⑦ patients with serious peripheral vascular diseases; ⑧ Pregnant and lactating women; ⑨ with severe cognitive and mental disorders; ⑩ the clinical researchers who were participating in other interventions within one month before selection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxygen treatmentdifferent kinds of oxygen treatments will be given to patients according to their state of illness | Other | Mild cases with conventional oxygen therapy, Moderate/Severe cases with nasal high flow oxygen inhalation, Moderate/Severe cases with non-invasive ventilation |
Primary outcome
Incidence of respiratory failure
Time frame: 28 day
Incidence of respiratory failure at day 28 after enrollment
1 secondary outcome
28 day mortality rate
Time frame: 28 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Background: PubMed 25810418Chan JF, Lau SK, To KK, Cheng VC, Woo PC, Yuen KY. Middle East respiratory syndrome coronavirus: another zoonotic betacoronavirus causing SARS-like disease. Clin Microbiol Rev. 2015 Apr;28(2):465-522. doi: 10.1128/CMR.00102-14.
- Background: PubMed 31992388Wu P, Hao X, Lau EHY, Wong JY, Leung KSM, Wu JT, Cowling BJ, Leung GM. Real-time tentative assessment of the epidemiological characteristics of novel coronavirus infections in Wuhan, China, as at 22 January 2020. Euro Surveill. 2020 Jan;25(3):2000044. doi: 10.2807/1560-7917.ES.2020.25.3.2000044.
- Related InfoLink provided by the sponsor.
- 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.
Xiaoju Zhang, PhD principal investigator
Henan Provincial People's Hospital
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 Coronavirus Disease-2019, run by Henan Provincial People's Hospital at 1 site in China.
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 1 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 18 Mar 2020. 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 China. 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?
Contact Ziqi Wang, MD (+86-13781919609, 13781919609@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of respiratory failure (time frame: 28 day). 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 NCT04312100, 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 18 Mar 2020.