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A medical records based study for safety and effectiveness analysis of data from novel coronavirus pneumonia (COVID-19) patients with conventional therapy

Safety and effectiveness analysis of data from novel coronavirus pneumonia (COVID-19) patients with conventional therapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000031376
Enrollment
Unknown
Registered
2020-03-29
Start date
2020-03-28
Completion date
Unknown
Last updated
2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Mild:No
severe:No

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Patients with confirmed cases meeting the following criteria: (1) Epidemiology history; (2) Clinical manifestations (epidemiological history and in accordance with any of the following 2 items; no clear epidemiology history, conforms to 3 items in clinical manifestations): Fever and / or respiratory symptoms; In the early stage of the disease, the total leukocyte count was normal or decreased, or the lymphocyte count decreased; Early chest imaging showed multiple small plaques and interstitial changes, which were evident in the extraneous lung. Further, multiple ground-glass shadows and infiltration shadows were found in both lungs, and lung consolidation and pleural effusion were rare in severe cases; (3) Having one of the following etiological evidence: Respiratory tract, blood or fecal samples RT-PCR confirmed infection with 2019-nCoV; The virus genes of the above samples were sequenced and highly homologous to the 2019-nCoV; 3. Patients who meet the following mild and normal criteria; Mild: mild clinical symptoms, no signs of pneumonia on imaging; Normal: fever, respiratory symptoms, imaging manifestations of pneumonia; 4.Patients who meet the following criteria of severe and critical severity (one of 3 and 4 is enough): (1) Criteria for severe patients (if any of them meet the criteria, they will be involved): Respiratory distress, RR >=30 times/min; (2) In the resting state, the oxygen saturation <=93%; (3) PaO2 / FiO2 <=300 mmHg; (4) Lung imaging showed that the lesions progressed more than 50% in 24-48 hours, which was managed according to heavy duty; Criteria for critical patients (only those who meet the conditions in Article 1 can be selected): (1) respiratory failure and mechanical ventilation is required; (2) shock; (3) Other organ failure should be monitored and treated by ICU. 5. The antimalarial drugs of chloroquine phosphate and hydroxychloroquine sulfate were not used within 3 months; 6. From February 19, 2020, hospitalized patients in Wuhan Tongji Hospital, the First Affiliated Hospital of Nanchang University, the Third Hospital of Beijing Medical University (Wuhan Center), the first hospital of Peking University, the people's Hospital of Peking University, and Haidian Hospital of the Third Hospital of Beijing Medical University.

Exclusion criteria

Exclusion criteria: 1. Patients with server diseases of the blood system; Patients with identified severe liver disease, underlying cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevation more than 3 times the normal upper limit; Patients with renal impairment (estimated glomerular filtration rate [eGFR]= 480ms; 4. Uncorrected patients with hypokalemia or hypokalemia; 5. Patients with psychiatric disorders; 6. Patients with pancreatitis; 7. Pregnant or breastfeeding women or female with positive pregnancy test at child-bearing age.

Design outcomes

Primary

MeasureTime frame
Safety;Effectiveness;

Countries

China

Contacts

Public ContactDongyang Liu

Peking University Third Hospital

liudongyang@vip.sina.com+86 18610966092

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026