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

NCT04594460 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2020-10-22

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Guangzhou Institute of Respiratory Disease

    lead OTHER

Principal Investigators

  • Wei-jie Guan, PhD · Guangzhou Institute of Respiratory Disease

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-31
Primary Completion
2021-10-31
Completion
2021-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04594460 on ClinicalTrials.gov