Sequential Oxygen Therapy Strategy for Patients With COVID-19

• Conditions: Coronavirus Disease-2019
• Interventions: Other: oxygen treatment

• Registration Number: NCT04312100
• Lead Sponsor: Henan Provincial People's Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Status Verified: 2020-03
• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-14
• Last Update Submitted: 2020-03-14
• Study First Posted: 2020-03-18
• Last Update Posted: 2020-03-18
• Primary Completion: 2020-10
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Moderate/Severe cases with non-invasive ventilation	oxygen treatment	COVID-19 patients who were considered Moderate/Severe cases will receive non-invasive positive pressure ventilation in addition to standard treatment
Mild cases with conventional oxygen therapy	oxygen treatment	COVID-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	oxygen treatment	COVID-19 patients who were considered Moderate/Severe cases will receive nasal high flow oxygen inhalation in addition to standard treatment

Primary Outcome Measures

Name	Time	Method
Incidence of respiratory failure	28 day	Incidence of respiratory failure at day 28 after enrollment

Secondary Outcome Measures

Name	Time	Method
28 day mortality rate	28 day	mortality rate at day 28 after enrollment

Trial Locations

Locations (1)

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China