NCT04594460

Hydrogen-oxygen Gas Mixture Inhalation in Patients With Convalescent Coronavirus Disease 2019 (COVID-19)

A Clinical Trial to Evaluate the Efficacy and Safety of Hydrogen-oxygen Mixed Gas Inhalation in Convalescent Severe/Critically Ill Patients With Novel Coronavirus Pneumonia (COVID-19)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Guangzhou Institute of Respiratory Disease · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, open, parallel-controlled study. Qualified subjects will randomly be assigned to the experimental arm or the control arm according to the ratio of 1:1, with age (\> 60 years or ≤ 60 years), smoking status (yes/no) and forced expiratory volume in one second/prediction (FEV1 %pred \> 60% or ≤ 60%) as the random stratification factors.

Detailed description

Subjects in the experimental arm and the control arm will receive hydrogen-oxygen mixed gas inhalation (Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03, output: 3 L/min (hydrogen concentration: 66.7%, oxygen concentration: 33.3%)) and oxygen inhalation (OLO-1 Medical Molecular Sieve Oxygen Generator, output: 3 L/min (oxygen concentration: 33.3%), Shanghai Ouliang Medical Devices Co., Ltd.), respectively; the treatment duration will not be less than 8 hours per day, for 12 weeks. Subjects in the experimental arm and the control arm will also receive other medications (excluding antiviral drugs) by the investigator as clinically indicated. Six visits are required for each subject in this study, including Visit 1 (D-7\~-1), Visit 2 (D1), Visit 3 (D14±3d), Visit 4 (D28±3d), Visit 5 (D56±7d), Visit 6 (D84±7d).

Conditions

• Covid19
• Hydrogen-oxygen Gas
• AMS-H-03

Interventions

Type	Name	Description
DEVICE	Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03	the experimental arm will receive hydrogen-oxygen mixed gas inhalation (Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03, output: 3 L/min (hydrogen concentration: 66.7%, oxygen concentration: 33.3%)) ,the treatment duration will be 8 hours per day, for 12 weeks.
DEVICE	OLO-1 Medical Molecular Sieve Oxygen Generator	the control arm will receive oxygen inhalation (OLO-1 Medical Molecular Sieve Oxygen Generator, output: 3 L/min (oxygen concentration: 33.3%), Shanghai Ouliang Medical Devices Co., Ltd.)the treatment duration will be 8 hours per day, for 12 weeks.

Timeline

• Start date: 2020-10-31
• Primary completion: 2021-10-31
• Completion: 2021-12-31
• First posted: 2020-10-20
• Last updated: 2020-10-22

Locations

2 sites across 1 country: China