COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=50462

Honghua Ye

yehonghua@medmail.com.cn

2020-03-16

Recruiting

RCT

Randomized

Parallel

Not reported

unclear

Treatment

1. Patients aged 18 or older, and meet the diagnostic criteria of Diagnosis and Treatment Scheme of Novel Coronavirus Infected Pneumonia published by the National Health Commission. Criteria for diagnosis (meet all the following criteria): (1) With epidemiological history, (2) Clinical manifestations (meet any 2 of the following): fever, normal or decreased white blood cell count or lymphopenia in the early stage of onset, and Chest radiology in the early stage shows multiple small patchy shadowing and interstitial changes which is especially significant in periphery pulmonary. Furthermore, it develops into bilateral multiple ground-glass opacity and infiltrating shadowing. Pulmonary consolidation occurs in severe cases. Pleural effusion is rare, (3) Confirmed case (suspected case obtained one of the following etiologic evidences): a positive result to real-time reverse-transcriptase PCR for respiratory specimen or blood specimen, or Genetic sequencing result of virus in respiratory or blood specimens are highly homologous to SARS-CoV-2, 2. The person is treated with de-isolation and meets hospital discharge criteria according to the 'Diagnosis and treatment of novel coronavirus pneumonia (trial edition 5)'. However, the respiratory nucleic acid turned positive and there were changes in lung imaging, 3. Gastrointestinal anatomy and function allowed and use safely, without nausea, vomiting and other gastrointestinal symptoms.

1. Gestational female patients, 2. Patients with other malignant diseases such as malignant tumours, chronic liver or kidney diseases, and reaching the end stage, 3. Patients with known psychiatric disorders, 4. Patients withdrawing from other clinical trial within 4 weeks.

2

HwaMei Hospital; University of Chinese Academy of Sciences

18

None

China

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

20

serum albumin;siderophilin;prealbumin;lung CT scanning result;

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

Not reported

[{"arm_notes": "", "treatment_id": 881, "treatment_name": "Newgen beta-gluten probiotic composite powder", "treatment_type": "Microbiota intervention", "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"}]