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

NCT04286503 | Unknown Phase 4

• 1 other identifier: BeijingYouan Hospital
• Study Type: interventional
• Target: 520
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Novel Coronavirus Infectious Disease (COVID-19)

Outcome Measures

Primary Outcomes (3)

• Fever to normal time (day)

  Fever to normal time (day)

  30 days

• Pulmonary inflammation resolution time (HRCT) (day)

  Pulmonary inflammation resolution time (HRCT) (day)

  30 days

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

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

  30 days

Study Arms (2)

Carrimycin

EXPERIMENTAL

basic treatment + Carrimycin

Drug: Carrimycin; Drug: basic treatment

lopinavir/ritonavir or Arbidol or chloroquine phosphate

ACTIVE COMPARATOR

any of basic treatment + lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate

Drug: lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate; Drug: basic treatment

Interventions

Carrimycin DRUG

Carrimycin

Carrimycin

lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate DRUG

lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate

lopinavir/ritonavir or Arbidol or chloroquine phosphate

basic treatment DRUG

basic treatment

Carrimycin; lopinavir/ritonavir or Arbidol or chloroquine phosphate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Clinical stratification:
• 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).
• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing YouAn Hospital: lead
• Shenyang Tonglian Group CO., Ltd: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• Huangshi Central Hospital: collaborator
• Shenyang Pharmaceutical University: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• No.2 People's Hospital of Fuyang City: collaborator
• The First Affiliated Hospital of Bengbu Medical University: collaborator
• Renmin Hospital of Wuhan University: collaborator
• The Sixth People's Hospital of Shenyang: collaborator
• Nanyang Central Hospital: collaborator

MeSH Terms

Conditions

COVID-19

Interventions

carrimycin; Lopinavir; Ritonavir; umifenovir; chloroquine diphosphate

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Study Officials

• Ronghua Jin

  Beijing YouAn Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huiguo Ding

CONTACT

+86-13911683832; dinghuiguo@medmail.com.cn

Ying Han

CONTACT

+86-13520809804; gladyshanying@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 27, 2020
• Study Start: February 23, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: February 27, 2020

Record last verified: 2020-02