Clinical trial NCT04312100: Sequential Oxygen Therapy Strategy for Patients With COVID-19
Official title: Sequential Oxygen Therapy Strategy for Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Disease-2019
Keywords: SARS-CoV-2
COVID-19
oxygen treatment
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only patients diagnosed with COVID-19 will be enrolled, diagnosis will depend on RT-PRC provided by China CDC

Brief 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


Eligibility criteria: 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; 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;

Primary outcomes:
measure: Incidence of respiratory failure
timeFrame: 28 day
Secondary outcomes:
measure: 28 day mortality rate
timeFrame: 28 day
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
Study officials:
affiliation: Henan Provincial People's Hospital
name: Xiaoju Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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):2000044. doi: 10.2807/1560-7917.ES.2020.25.3.2000044.