COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=53048

Shuihua Lu

tubercle@shphc.org

2020-04-29

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

1. Meet the diagnostic criteria for COVID-19 Suspected cases: Epidemiological history: Travel history or residence history in Wuhan and surrounding areas or other communities with case reports within 14 days before the onset of illness, Have a history of contact with SARS-CoV-2(i.e. novel coronavirus 2019) infected persons (positive nucleic acid test) within 14 days before onset, Patients with fever or respiratory symptoms from Wuhan and surrounding areas or from communities with case reports within 14 days before the onset of illness, Cluster onset (within 2 weeks in a small area such as home, office, school class, etc., 2 or more cases of fever and / or respiratory symptoms occurred. Clinical manifestations: Fever and / or respiratory symptoms, The imaging features of the COVID-19, The total number of white blood cells is normal or decreased in the early stage of onset, and the lymphocyte count is normal or decreased, Have any one of the epidemiological history and meet any two of the clinical manifestations. If there is no clear epidemiological history, it meets 3 of the clinical manifestations. Confirmed cases: Suspected cases have one of the following etiology or serological evidence: Real-time fluorescent RT-PCR detection of new coronavirus nucleic acid positive, Viral gene sequencing, highly homologous to known new coronaviruses, Serum ARS-oV-2-specific IgM antibodies and IgG antibodies were positive, serum nSARS-CoV-2-specific IgG antibodies changed from negative to positive or the recovery period was 4 times or more higher than in the acute phase, 2. Patients within 7 days of onset, or patients without clinical symptoms but confirmed within 7 days, 3. Patients who are over 18 years of age and have normal autonomous judgment ability are not limited to men and women, 4. Patients who volunteered to participate in the trial and signed informed consent.

1. Patients who are clinically classified as severe and meet any of the following: 1) Shortness of breath, RR >=30 times / minute, 2) In the resting state, the oxygen saturation <=93%, 3) Arterial blood oxygen partial pressure (PaO2) / oxygen concentration (FiO2) <=300mmHg (1mmHg = 0.133kPa). At high altitudes (above 1000 meters), PaO2 / FiO2 is corrected according to the following formula: PaO2 / FiO2 x [Atmospheric Pressure (mmHg) / 760], Chest CT-scan showed that the lesions progressed significantly within 24 to 48 hours, 2. Have a significant disease other than SARS-CoV-2 infection, that is, a disease that, according to the investigator's judgment, may cause the subject to be at risk because of participation in the research, or have an impact on the results of the research and the ability of the subject to participate in the research, 3. A history of severe heart disease such as acute myocardial infarction, congestive heart failure (NYHA Class III and above), severe arrhythmia, and other patients with acute heart disease, 4. There are serious primary diseases of important organs and systems: such as acute stroke, moderate or higher hypertension after treatment, active gastric ulcer, diabetes (serious complications), malignant tumor, etc ., 5. Limited understanding and poor compliance, 6. Does not have legal capacity or is restricted, 7. Pregnant, lactating women and women of childbearing age who do not agree to effective contraception during the study, 8. Researchers do not consider it appropriate to participate in this research.

2

Shanghai Public Health Clinical Center

18

65

China

Moderate disease at enrollment

3: Moderate disease at enrollment

100

Improvement of anxiety; depression;CAP symptoms improvement;

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

Not reported

[{"arm_notes": "", "treatment_id": 943, "treatment_name": "Oxygen", "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"}]