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The Clinical Study of Carrimycin on Treatment Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04286503
Recruitment Status : Not yet recruiting
First Posted : February 27, 2020
Last Update Posted : February 27, 2020
Sponsor:
Collaborators:
Shenyang Tonglian Group Co., Ltd.
Institute of Medicine and Biotechnology, Chinese Academy of Medical Sciences
Huangshi Central Hospital
Shenyang Pharmaceutical University
First Affiliated Hospital of Chongqing Medical University
The Second Affiliated Hospital of Harbin Medical University
No.2 People's Hospital of Fuyang City
First Affiliated Hospital Bengbu Medical College
Renmin Hospital of Wuhan University
The sixth people's hospital of Shenyang
Nanyang Central Hospital
Information provided by (Responsible Party):
Jin Ronghua, Beijing YouAn Hospital

Brief Summary:
The novel coronavirus infectious disease ( COVID-19") induced by novel coronavirus(SARS-CoV-2) in December 2019 has outbreaked in Wuhan. It may lead to epidemic risk in global. As the COVID-19 is an emerging infectious disease, it has not scientifically recognized and has no effective drugs for treatment currently. Therefore, we will launch a scientific project "The efficacy and safety of carrimycin treatment in 520 patients with COVID-19 stratificated clinically: A multicenter, randomized (1:1), open-controlled (one of lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate) study" . We try to establish the criteria for clinical cure and the early predictive model of COVID-19 progression. The primary efficiency outcomes were:(1) Fever to normal time (day); (2) Pulmonary inflammation resolution time (HRCT) (day); and (3)Negative conversion (%) of SARS-CoV-2 RNA at the end of treatment. The secondary efficiency outcomes and adverse events were observed.

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

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Carrimycin
basic treatment + Carrimycin
Drug: Carrimycin
Carrimycin

Drug: basic treatment
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
basic treatment




Primary Outcome Measures :
  1. Fever to normal time (day) [ Time Frame: 30 days ]
    Fever to normal time (day)

  2. Pulmonary inflammation resolution time (HRCT) (day) [ Time Frame: 30 days ]
    Pulmonary inflammation resolution time (HRCT) (day)

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Subjects are aged ≥ 18 and ≤ 75;
  3. Meet the diagnostic criteria for 2019-nCoV pneumonia (V5.0);
  4. SOFA score: 1 ~ 13 points.
  5. 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.

Clinical stratification:

  1. Mild type: clinical symptoms mild or asymptomatic, no pneumonia performance in CT, but positive 2019-nCoV in throat swabs or gargle.
  2. Ordinary type: fever, respiratory symptoms, etc., pneumonia performance visible in CT.
  3. 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.

Exclusion Criteria:

  1. Other viral pneumonia
  2. 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;
  3. Patients who have taken anti-bacterial drugs such as macrolide in the past 1 week;
  4. Patients who have received organ transplantation or surgery planning in the past 6 months;
  5. Patients who can't take food or drugs due to coma or intestinal obstruction;
  6. 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.
  7. 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;
  8. Patients with allergic constitution, or patients allergic to macrolides and lopinavir/ritonavir tablets;
  9. 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;
  10. 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.
  11. ECLS (ECMO, ECCO2R, RRT)
  12. Critical patients with expected life<48 hours
  13. Patients who have participated in any other clinical study within 1 month;
  14. The investigators conclude that the patients not suitable for the study.

Information from the National Library of Medicine

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


Contacts
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Contact: Huiguo Ding +86-13911683832 dinghuiguo@medmail.com.cn
Contact: Ying Han +86-13520809804 gladyshanying@163.com

Sponsors and Collaborators
Beijing YouAn Hospital
Shenyang Tonglian Group Co., Ltd.
Institute of Medicine and Biotechnology, Chinese Academy of Medical Sciences
Huangshi Central Hospital
Shenyang Pharmaceutical University
First Affiliated Hospital of Chongqing Medical University
The Second Affiliated Hospital of Harbin Medical University
No.2 People's Hospital of Fuyang City
First Affiliated Hospital Bengbu Medical College
Renmin Hospital of Wuhan University
The sixth people's hospital of Shenyang
Nanyang Central Hospital
Investigators
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Principal Investigator: Ronghua Jin Beijing YouAn Hospital
  Study Documents (Full-Text)

Documents provided by Jin Ronghua, Beijing YouAn Hospital:
Study Protocol  [PDF] February 20, 2020
Informed Consent Form  [PDF] February 20, 2020


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Responsible Party: Jin Ronghua, Director, Beijing YouAn Hospital
ClinicalTrials.gov Identifier: NCT04286503    
Other Study ID Numbers: BeijingYouan Hospital
First Posted: February 27, 2020    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Ritonavir
Lopinavir
Chloroquine
Chloroquine diphosphate
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents