COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49887

Wei Yang

hydyangwei@tom.com

2020-02-26

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

(1) Adults aged >=18 years understand and agree to sign informed consent, (2) a novel coronavirus infection confirmed by laboratory RT-PCR. (3) Hospitalized patients with fever (axillary temperature >=37.0 degree C) or respiratory symptoms, (4) The interval between symptom onset and immediate enrollment is within 14 days, (5) Those who did not participate in other clinical trials within 3 months, (6) No other antiviral drugs were involved in the follow-up study within 14 days.

(1) novel coronavirus pneumonia is a disease or condition beyond the pneumonia. That is, according to the researchers' judgement, the subjects will be at risk for taking part in the research, or will have an impact on the results of the study and the ability of the subjects to participate in the study, (2) A woman who is pregnant or breastfeeding or who plans to be pregnant during the study period, (3) Combined with heart, liver, kidney, hematopoietic system and other important organs or systems of serious primary diseases, (4) Severe and critical patients: respiratory distress, RR >=30 times / min, in resting state, oxygen saturation <= 93%, arterial partial pressure of oxygen (PaO2) / concentration of oxygen (FiO2) < 300MMHG, respiratory failure, mechanical ventilation, shock, other organ failure requiring ICU monitoring and treatment, (5) Patients over 70 years old, (6) Patients with mental disorders and cognitive disorders, (7) Those who have poor compliance, are unwilling to participate in the project or do not sign the informed consent during their stay in the hospital. There are doubts about the validity of informed consent: subjects with mental illness, mental retardation, poor motivation, drug abuse (including drugs and alcohol) or other disease history restricting the validity of informed consent in this study, (8) Patients with glucocorticoid, (9) The researchers think it is not suitable to participate in this study.

2

The Fourth Affiliated Hospital of Harbin Medical University

18

70

China

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

60

temperature;respiratory rate;Blood oxygen saturation;Cough symptom;Lung CT;Fatality rate;

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 0

[{"arm_notes": "", "treatment_id": 604, "treatment_name": "Hydrogen inhalation", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]