SOTSPC: Sequential Oxygen Therapy Strategy for Patients With COVID-19

• Sponsor: Henan Provincial People's Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04312100
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Disease-2019	Other: oxygen treatment

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Sequential Oxygen Therapy Strategy for Patients With COVID-19
• Actual Study Start Date: Feb 1, 2020
• Anticipated Primary Completion Date: Oct 1, 2020
• Anticipated Study Completion Date: Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Mild cases with conventional oxygen therapy COVID-19 patients who were considered mild cases will receive conventional oxygen therapy in addition to standard treatment	Other: oxygen treatment; different kinds of oxygen treatments will be given to patients according to their state of illness
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	Other: oxygen treatment; different kinds of oxygen treatments will be given to patients according to their state of illness
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	Other: oxygen treatment; different kinds of oxygen treatments will be given to patients according to their state of illness

Outcome Measures

Primary Outcome Measures

1. Incidence of respiratory failure [28 day]

   Incidence of respiratory failure at day 28 after enrollment

Secondary Outcome Measures

1. 28 day mortality rate [28 day]

   mortality rate at day 28 after enrollment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henan Provincial People's Hospital	Zhengzhou	Henan	China	450000

Sponsors and Collaborators

• Henan Provincial People's Hospital

Investigators

• Principal Investigator: Xiaoju Zhang, PhD, Henan Provincial People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

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. Review.
• 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.

• Responsible Party: Henan Provincial People's Hospital
• ClinicalTrials.gov Identifier: NCT04312100
• Other Study ID Numbers: SOT-C
• First Posted: Mar 18, 2020
• Last Update Posted: Mar 18, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Henan Provincial People's Hospital: SARS-CoV-2; COVID-19; oxygen treatment
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Mar 18, 2020