Skip to content

The efficacy and safety of carrimycin treatment in patients with novel coronavirus pneumonia (COVID-19): a multicenter, randomized, open-label, controlled trial

The efficacy and safety of carrimycin treatment in patients with novel coronavirus pneumonia (COVID-19): a multicenter, randomized, open-label, controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029867
Enrollment
Unknown
Registered
2020-02-15
Start date
2020-02-15
Completion date
Unknown
Last updated
2020-02-17

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

Experimental group:Carrimycin
Control group:Lopinavir and Ritonavir Tablets

Sponsors

Beijing You'an Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Subjects have signed informed consent; agree not to participate in other clinical studies within 30 days from the first administration of the research drug to the last administration. 2. Aged >= 18 and = 30 times / minute. (2) In the resting state, the oxygen saturation is <= 93%. (3) Arterial blood oxygen partial pressure (PaO2) / oxygen concentration (FiO2) <= 300mmHg (1mmHg = 0.133kPa). 4. Critical type (n = 80): One of the following criteria: (1) Respiratory failure (ARDS) occurs and requires mechanical ventilation. (2) Shock. (3) Combined failure of other organs requires ICU monitoring and treatment.

Exclusion criteria

Exclusion criteria: 1. Patients who have received immunotherapy (such as PD-1 / L1, CTLA4, etc.) and inflammatory factor modulators (such as Ulinastatin) within one month. 2. Patients who have used antibacterial drugs such as macrolides within one week. 3. Patients who have received other anti-2019-nCOV potentially effective drugs such as Lopinavir and Ritonavir within one week. 4. Those who have undergone organ transplantation or surgery planning within 6 months. 5. Patients with coma or intestinal obstruction can not eat or take medicine. 6. With severe illness affected survival, including uncontrolled malignant tumors that have been metastatic and can not be removed, blood diseases, cachexia, active bleeding, severe malnutrition, HIV, etc.. 7. Pregnant and lactating women, subjects (including male subjects) have a pregnancy plan (including sperm donation, egg donation plan) within the next 6 months or are unable to take effective contraceptive measures. 8. Patients with allergies or allergies to macrolide drugs, lopinavir / ritonavir tablets. 9. Patients with contraindications to using lopinavir / ritonavir tablets who plan or are using drugs that interact with the drug (including: highly dependent on CYP3A clearance and increased plasma concentrations can be severe and / or Life-threatening events [narrow therapeutic index] drugs, CYP3A inducers [see the instructions for details]), and can not be stopped or switched to other drugs. 10. Elevated alanine aminotransferase (ALT) / glutaminase (AST) is more than five times the upper limit of normal, total bilirubin is three times the upper limit of normal, or child-Pugh grade C cirrhosis. 11. Extracorporeal life support (ECMO, ECCO2R, RRT). 12. Critical patients with an estimated survival time of < 48 h. 13. Participants in other clinical research in the past month. 14. At the investigator's discretion, patients were deemed unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Body temperature returns to normal time;Pulmonary inflammation resolution time (HRCT);Mouthwash (pharyngeal swab) at the end of treatment COVID-19 RNA negative rate;

Countries

China

Contacts

Public ContactRonghua Jin

Beijing You'an Hospital, Capital Medical University

dinghuiguo@medmail.com.cn+86 13811611118

Outcome results

None listed

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