The Clinical Study of Carrimycin on Treatment Patients With COVID-19
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|ClinicalTrials.gov Identifier: NCT04286503|
Recruitment Status : Unknown
Verified February 2020 by Jin Ronghua, Beijing YouAn Hospital.
Recruitment status was: Not yet recruiting
First Posted : February 27, 2020
Last Update Posted : February 27, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Novel Coronavirus Infectious Disease (COVID-19)||Drug: Carrimycin Drug: lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate Drug: basic treatment||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||520 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy and Safety of Carrimycin Treatment in Patients With Novel Coronavirus Infectious Disease (COVID-19) : A Multicenter, Randomized, Open-controlled Study|
|Estimated Study Start Date :||February 23, 2020|
|Estimated Primary Completion Date :||February 28, 2021|
|Estimated Study Completion Date :||February 28, 2021|
basic treatment + Carrimycin
Drug: basic treatment
Active Comparator: lopinavir/ritonavir or Arbidol or chloroquine phosphate
any of basic treatment + lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate
Drug: lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate
lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate
Drug: basic treatment
- Fever to normal time (day) [ Time Frame: 30 days ]Fever to normal time (day)
- Pulmonary inflammation resolution time (HRCT) (day) [ Time Frame: 30 days ]Pulmonary inflammation resolution time (HRCT) (day)
- Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment [ Time Frame: 30 days ]Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subjects or their legal representatives have signed the informed consent form(ICF); agree not to participate in other clinical studies within 30 days after the last administration from the first administration of the study drug.
- Subjects are aged ≥ 18 and ≤ 75;
- Meet the diagnostic criteria for 2019-nCoV pneumonia (V5.0);
- SOFA score: 1 ~ 13 points.
A retreated patient or the relapsed patient meets any of the following criteria:
- Have fever again or aggravated clinical symptoms; ② 2019nCOVRNA in the throat swabs converts from negative to positive; ③ The clinical symptoms don't improve or 2019nCOVRNA continues to be positive; ④ The chest CT shows pneumonia or fibrosis progression.
- Mild type: clinical symptoms mild or asymptomatic, no pneumonia performance in CT, but positive 2019-nCoV in throat swabs or gargle.
- Ordinary type: fever, respiratory symptoms, etc., pneumonia performance visible in CT.
- Severe type: meeting any of the following criteria:
(1) Respiratory distress, RR≥30 times/min; (2) Finger oxygen saturation ≤93% in rest state; (3) Arterial partial pressure of oxygen (PaO2)/concentration of oxygen inhalation (FiO2)≤300mmHg (1mmHg=0.133kPa).
4. Critical type: meeting any of the following criteria:(1)Respiratory failure occurs and mechanical ventilation is required;(2)Patients go into shock;(3)ICU is needed for other organ failure.
- Other viral pneumonia
- Patients who have received tumor immunotherapy (such as PD-1/L1, CTLA4, etc.) in the past 1 month, and inflammatory factor modulators such as Ulinastatin;
- Patients who have taken anti-bacterial drugs such as macrolide in the past 1 week;
- Patients who have received organ transplantation or surgery planning in the past 6 months;
- Patients who can't take food or drugs due to coma or intestinal obstruction;
- Patients who have severe underlying diseases that affects survival, including uncontrolled malignant tumor with multiple metastases that cannot be resected, blood diseases, dyscrasia, active bleeding, severe malnutrition, etc.
- Women subjects that are pregnant or lactating, or subjects (including male subjects) having a pregnancy plan (including plans for sperm donation or egg donation), or subjects that may fail to take effective contraceptive measures within the next 6 months;
- Patients with allergic constitution, or patients allergic to macrolides and lopinavir/ritonavir tablets;
- Patients with contraindications to lopinavir/ritonavir tablets who plan or are using drugs that interact with the drug (including: drugs that are highly dependent on CYP3A clearance and whose elevated plasma concentrations can be associated with severe and/or life-threatening events [with a narrow therapeutic index], CYP3A inducer [see instruction for details]) and cannot stop using or use other drugs instead;
- Patients whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal, or patients with child-Pugh grade C cirrhosis.
- ECLS (ECMO, ECCO2R, RRT)
- Critical patients with expected life<48 hours
- Patients who have participated in any other clinical study within 1 month;
- The investigators conclude that the patients not suitable for the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04286503
|Contact: Huiguo Dingemail@example.com|
|Contact: Ying Hanfirstname.lastname@example.org|
|Principal Investigator:||Ronghua Jin||Beijing YouAn Hospital|
Documents provided by Jin Ronghua, Beijing YouAn Hospital:
|Responsible Party:||Jin Ronghua, Director, Beijing YouAn Hospital|
|Other Study ID Numbers:||
|First Posted:||February 27, 2020 Key Record Dates|
|Last Update Posted:||February 27, 2020|
|Last Verified:||February 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
HIV Protease Inhibitors
Viral Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors