Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2026-01-01 @ 12:02 AM
Study NCT ID:
NCT05770206
Status:
UNKNOWN
Last Update Posted:
2023-03-15
First Post:
2023-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydrogen-Oxygen Generator With Nebulizer for Adjuvant Treatment of Novel Coronavirus Disease 2019 (COVID-19)
Sponsor:
Guangzhou Institute of Respiratory Disease
Organization:
Study Overview
Official Title:
A Multi-center, Randomized, Parallel Controlled, Double-Blinded Clinical Trial to Evaluate the Effectiveness and Safety of Hydrogen-Oxygen Generator With Nebulizer for Adjuvant Treatment of Novel Coronavirus Disease 2019 (COVID-19)
Status:
UNKNOWN
Status Verified Date:
2023-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center, randomized, parallel controlled, double-blinded clinical trial to evaluate the effectiveness and safety of Hydrogen-Oxygen Generator with Nebulizer for adjuvant treatment of COVID-19 patients. The test group is expected to be superior to the control group in the primary endpoint (percentage of subjects achieving clinical recovery at Day 7 of study treatment). Subjects in the test group will receive treatment by using Hydrogen-Oxygen Generator with Nebulizer (manufactured by Shanghai Asclepius Meditec Co., Ltd., flow rate: 3L/min) combined with conventional basic supportive treatment (symptomatic support treatment determined by the investigator based on the condition of the subjects); and subjects in the control group will receive treatment by using Medical Molecular Sieve Oxygen Generator (manufactured by Shanghai Ouliang Medical Devices Co., Ltd., flow rate: 3L/min, provided by the sponsor) combined with conventional basic supportive treatment (same with that in the test group).
Detailed Description:
Data of the following effectiveness and safety endpoints of subjects in the two groups will be collected and analyzed in this study, including of the primary effectiveness endpoint: percentage of subjects achieving clinical recovery at Day 7 of study treatment; and the secondary effectiveness endpoints: percentage of subjects achieving clinical recovery on Day 2, 3, 5, 10 of study treatment and that before discharge; percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more on Day 2, 3, 5, 7, 10 of study treatment and before discharge; reduction of WHO Clinical Progression Scale score on Day 2, 3, 5, 7, 10 of study treatment and before discharge; changes in COVID-19 symptom scores on Day 2, 3, 5, 7, 10 of study treatment and before discharge; total length of hospital stay; time from randomization to conversion to general COVID-19; time from randomization to conversion to mild COVID-19 disease; percentage of patients with no fever, shortness of breath and chest pain on Day 2, 3, 5, 7, 10 of study treatment and before discharge; Oxygen saturation based on finger blood samples in resting non-oxygen inhalation state; and safety evaluation variables including incidences of AEs, SAEs and device deficiencies.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: