COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=58343

Lu Hongzhou

luhongzhou@shphc.org.cn

2021-09-30

Recruiting

RCT

Randomized

Parallel

Not reported

single-center

Treatment

All inclusion criteria must be met to qualify for inclusion: 1. The age should be over 18 years old and under 70 years old, with no gender limit. Those who meet the diagnostic criteria of clinical pneumonia 2. According to the clinical diagnosis of viral pneumonia: (1) Fever (oral temperature >= 38 degrees C, or axillary temperature >= 37.5 degrees C, or fever history within 24 hours before baseline, whether taking antipyretics or not, or having fever symptoms within 48 hours before baseline), with or without respiratory symptoms (respiratory rate > 30 beats / min), (2) White blood cell count was normal or low, with or without thrombocytopenia, (3) Chest imaging (chest CT): unilateral or bilateral chest imaging showed multiple (at least 2 lesions) or diffuse patchy or ground glass infiltration (with or without consolidation), 3. SARS-COV-2 is positive for pathogens. After respiratory virus screening, oropharyngeal test pieces with one or more virus nucleic acid positive can be selected into the group. The SARS-COV-2 in the samples were further evaluated by qPCR according CT valune, 4. Prior to the start of the study, a written informed letter should be signed (for the incompetent subjects, if the researcher thinks that it is in their own interests to participate in the trial, the informed consent shall be signed by the legal guardian of the subject, and it shall be explained in the original medical record and other relevant documents).

Those who meet any of the following criteria shall not be included in the group: 1. There were serious noninfectious pulmonary diseases, including pulmonary tumor, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophilic infiltration and pulmonary vasculitis, 2. Severe liver and kidney dysfunction: (1) ALT and AST value were more than 10 times higher than the upper limit of normal value, (2) Serum creatinine value was more than 1.5 times higher than the upper limit of normal value, (3) Total bilirubin was more than 2 times the upper limit of normal value, 3. Patients with biliary obstruction, 4. Pregnant women (urine or serum pregnancy test positive) or lactating women, 5. Other subjects considered unsuitable by the researchers for this trial, or the researchers think that there may be any situation that may increase the risk of subjects or interfere with the clinical trial.

2

Shanghai Public Health Clinical Center

18

70

China

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

300

Hyaluronic acid;Virus negative time;

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

Phase 0

[{"arm_notes": "", "treatment_id": 2021, "treatment_name": "Hymecromone", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]