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The Efficacy and Safety of Carrimycin Treatment in Patients With Novel Coronavirus Infectious Disease (COVID-19) : A Multicenter, Randomized, Open-controlled Study

Trial Profile

The Efficacy and Safety of Carrimycin Treatment in Patients With Novel Coronavirus Infectious Disease (COVID-19) : A Multicenter, Randomized, Open-controlled Study

Status: Not yet recruiting
Phase of Trial: Phase IV

Latest Information Update: 22 Jun 2020

At a glance

  • Drugs Carrimycin (Primary) ; Chloroquine; Lopinavir/ritonavir; Umifenovir
  • Indications COVID 2019 infections; Pneumonia; Respiratory distress syndrome
  • Focus Therapeutic Use
  • Most Recent Events

    • 06 Mar 2020 New trial record

Trial Overview

Purpose

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.

Primary Endpoints

Fever to normal time (day)

description: Fever to normal time (day)
time_frame: 30 days

Pulmonary inflammation resolution time (HRCT) (day)

description: Pulmonary inflammation resolution time (HRCT) (day)
time_frame: 30 days

Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment

description: Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment
time_frame: 30 days

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Pneumonia treatment -
Respiratory distress syndrome treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 520

  • Sex male & female
  • Age Group 18-75 years; adult; elderly

Patient 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.

Patient 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.

Trial Details

Identifiers

Identifier Owner
ChiCTR2000029867 Chinese Clinical Trial Register
NCT04286503 ClinicalTrials.gov: US National Institutes of Health

Organisations

  • Affiliations Shenyang Tonglian Group

Trial Dates

  • Initiation Dates

    Planned : 23 Feb 2020

  • Primary Completion Dates

    Planned : 28 Feb 2021

  • End Dates

    Planned : 28 Feb 2021

Other Details

  • Design multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase IV
  • Location China
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
CarrimycinPrimary Drug Oral Tablet
Chloroquine
-
-
Lopinavir/ritonavir Oral Tablet
Umifenovir
-
-

Carrimycin

basic treatment + Carrimycin
Drug: Carrimycin (Carrimycin)
Drug: basic treatment (basic treatment)

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)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Huiguo Ding
+86-13911683832
dinghuiguo@medmail.com.cn
show details
-
Ronghua Jin Beijing YouAn Hospital
-
Ying Han
+86-13520809804
gladyshanying@163.com
show details
-

Centres

Centre Name Location Trial Centre Country
-
-
-
Beijing YouAn Hospital
-
-
First Affiliated Hospital Bengbu Medical College
-
-
First Affiliated Hospital of Chongqing Medical University
-
-
Huangshi Central Hospital
-
-
Institute of Medicine and Biotechnology, Chinese Academy of Medical Sciences
-
-
Nanyang Central Hospital
-
-
No.2 People's Hospital of Fuyang City
-
-
Renmin Hospital of Wuhan University
-
-
Shenyang Pharmaceutical University
-
-
Shenyang Tonglian Group Co., Ltd.
-
-
The Second Affiliated Hospital of Harbin Medical University
-
-
The sixth people's hospital of Shenyang
-
-

Trial History

Event Date Event Type Comment
22 Jun 2020 Other trial event New source identified and integrated (Chinese Clinical Trial Register: ChiCTR2000029867) Updated 22 Jun 2020
06 Mar 2020 New trial record New trial record Updated 06 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Chinese Clinical Trial Register. Trial-Reg 2016;.

    Available from: URL: http://www.chictr.org
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