Sequential Oxygen Therapy Strategy for Patients With COVID-19

Coronavirus Disease-2019 Clinical Trial

— SOTSPC  

Official title:

Sequential Oxygen Therapy Strategy for Patients With COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04312100
• Other study ID #: SOT-C
• Status: Recruiting
• Start date: February 1, 2020
• Est. completion date: February 2021

Study information

• Verified date: March 2020
• Source: Henan Provincial People's Hospital
• Contact: Ziqi Wang, MD
• Phone: +86-13781919609
• Email: 13781919609[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with COVID-19

• Aged between 18-75 years;

• Willing to sign the informed consent voluntarily.

Exclusion Criteria:

• Patients with active tuberculosis, idiopathic pulmonary fibrosis, bronchial asthma, bronchiectasis, pulmonary embolism, chronic respiratory failure or other serious respiratory diseases; ? patients with serious cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina, acute myocardial infarction, cardiac function grade 3 or above, stroke, cerebral hemorrhage, etc.); ? 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); ? tumor patients who have undergone resection, radiotherapy and chemotherapy within 5 years; ? patients who have difficulty in activity due to neuromuscular diseases; ? patients with serious arthritis; ? patients with serious peripheral vascular diseases; ? Pregnant and lactating women; ? with severe cognitive and mental disorders; ? the clinical researchers who were participating in other interventions within one month before selection;

Related Conditions & MeSH terms

• Coronavirus Disease-2019
• Coronavirus Infections

Intervention

Other:
• oxygen treatment
different kinds of oxygen treatments will be given to patients according to their state of illness

Locations

Country	Name	City	State
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Provincial People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Review. — View Citation

Wu 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). doi: 10.2807/1560-7917.ES.2020.25.3.2000044. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of respiratory failure	Incidence of respiratory failure at day 28 after enrollment	28 day
Secondary	28 day mortality rate	mortality rate at day 28 after enrollment	28 day

External Links

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