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

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)

Interventions

DRUG

Carrimycin

Carrimycin

DRUG

lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate

lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate

DRUG

basic treatment

basic treatment

Sponsors & Collaborators

• Shenyang Tonglian Group CO., Ltd

  collaborator INDUSTRY

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  collaborator OTHER

• Huangshi Central Hospital

  collaborator OTHER

• Shenyang Pharmaceutical University

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• No.2 People's Hospital of Fuyang City

  collaborator UNKNOWN

• The First Affiliated Hospital of Bengbu Medical University

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• The Sixth People's Hospital of Shenyang

  collaborator OTHER

• Nanyang Central Hospital

  collaborator OTHER

• Beijing YouAn Hospital

  lead OTHER

Principal Investigators

• Ronghua Jin · Beijing YouAn Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-23

Primary Completion

2021-02-28

Completion

2021-02-28