COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49165

Qu Jieming

jmqu0906@163.com

2020-02-07

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Sign the informed consent form, 2. Aged >=18 years, 3. Subjects diagnosed as 2019-nCoV pneumonia, (1) Detection of 2019-nCoV nucleic acid positive by RT-PCR in respiratory tract or blood samples, (2) The virus gene sequence of respiratory tract or blood samples is highly homologous to the known 2019-nCoV, 4. According to the standard of 2019-nCoV pneumonia diagnosis and treatment Program of New Coronavirus infection (trial Fifth Edition) issued by National Health Commission of China, clinical classification: mild, ordinary subjects, (1) Mild type, the clinical symptoms were mild and no pneumonia was found in imaging, (2) Common type, With fever, respiratory tract and other symptoms, the manifestations of pneumonia can be seen on imaging.

1. Critical type: If one of the following conditions is met (1) Respiratory failure occurs and mechanical ventilation is needed, (2) Shock occurred, (3) Patients with other organ failure need ICU monitoring treatment, 2. Severe type: If one of the following conditions is met (1) Respiratory distress, RR >= 30 beats / min, (2) In resting state, finger oxygen saturation (SaO2) <= 93%, (3) Partial pressure of arterial oxygen (PaO2) / concentration of oxygen inhaled (FiO2)<= 300mmHg, 3. Those who have a history of allergy to this class of drugs and / or severe allergic constitution, 4. The results of laboratory tests are abnormal: (1) Hematological dysfunction is defined as: 1) Platelet (PLT) count <100x10^9/L, 2) Hemoglobin (Hb) level <90g/L, (2) Abnormal liver function is defined as: 1) Level of total bilirubin(TBil) >2 ULN, 2) The levels of aspartate aminotransferase (AST) and Alanine transaminase (ALT)>3 ULN, 3) Definition of renal dysfunction: Serum creatinine>1.5 ULN, or calculated creatinine clearance<50ml/min, 4) Definition of abnormal blood coagulation: International normalized ratio(INR) >1.5 ULN, and the prothrombin time ((PT)) or activated partial thromboplastin time (aPTT) 1.5 ULN, unless the subject is receiving anticoagulant therapy, 5. Abidor was used before inclusion(Tablets, capsules, granules), 6. Women who are nursing or pregnant, 7. Serum or urine pregnancy tests were positive for women of child-bearing age, 8. Immunodeficient patient(Patients with malignant tumors, Organ or bone marrow transplant, HIV patient, those who took immunosuppressive drugs within 3 months before the screening test ), 9. With the following history of present illness: (1) Neurological and neurodevelopmental disorders, These include diseases of the brain, spinal cord, peripheral nerves and muscles(Such as cerebral palsy, epilepsy, stroke, mental retardation, moderate to severe developmental delay, muscular malnutrition or spinal cord injury ), (2) Circulation system disease( congenital heart disease, Congestive heart failure or coronary artery disease), (3) Severe heart disease or a history of clinically significant arrhythmias that the researchers believe will affect participants' safety (According to the ECG or medical history), 10. Other patients considered ineligible for this study were considered ineligible by the investigators.

2

Ruijin Hospital; Shanghai Jiao Tong University School of Medicine

18

None

China

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

380

Virus negative conversion rate in the first week;

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

Phase 4

[{"arm_notes": "", "treatment_id": 1336, "treatment_name": "Umifenovir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]