Beijing Youan Hospital launched a study on February 23, 2020, to investigate the efficacy and safety of a drug developed in China called Carrimycin against COVID-19. Developed for upper respiratory infections among other things, the drug was approved by the National Medical Products Administration and launched in June 2019 to little press. The drug was the result of a collaboration between Institute of Medicinal Biotechnlogy (Chinese Academy of Medical Sciences) and the Shenyang Tonglian Group Co. The study, funded by the national government, includes a large list of prominent Chinese research institution collaborators and is enrolling 520 patients. Interestingly, researchers had to dig fairly deep for readily available information about this drug until the advent of the pandemic. Then it has been touted as a potential treatment but no results have been shared with the world as of yet.
What is Carrimycin?
A drug touted as developed in China was approved by the country’s National Medical Products Administration on June 24, 2019. This drug was specifically developed to treat upper respiratory infections. With a trade name of “Bite,” the new antibiotic was developed by a team led by Professor Yiguang Wang, Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences with “synthetic technology” and a Class I innovative drug developed in cooperation with Shenyang Tonglian Group Co. Ltd. As reported in the website of the Chinese Academy of Medical Sciences, Peking Union Medical College, “China possess the completely proprietary intellectual property rights and key core technology of this drug.”
History of Carrimycin
The history of this treatment goes back to 2003 when the Institute of Medicinal Biotechnology and Shenyang Tonglian Group Co. Ltd initiated a collaboration to develop this treatment. In that span of time, the group accumulated 16 domestic patents, 4 of which were authorized in 12 PCT member countries including the U.S., Canada, EU, etc. The drug has strong antibacterial activity and according to its sponsors, significant inhibitory activity against mycoplasma and chlamydia without obvious cross resistance to similar drugs.
As well as drug-resistant gram-positive bacterial, the drug, its sponsors tout, isvery effective against some bacteria producing β-lactamase, and active against some gram-negative bacteria (such as clostridium difficile and bacillus influenzae ) and fungal candida albicans. The sponsors tout they have patented the drug’s resistance against mycobacterium tuberculosis infection.
The study Phase 4 (approved) study was published on Clinicaltrials.gov on February 27, 2020 and sponsored by Beijing Youan Hospital, Capital Medical University. This multicenter, randomized (1:1), open-controlled study (one of lopinavir/ritonavir or Arbidol or chloroquine phosphate). Ambitious in objective, the sponsor seeks to establish the criteria for clinical cure and the early predictive model of COVID-19 progression. The study team seeks the primary efficiency outcomes including 1) fever to normal time (day); 2) pulmonary inflammation resolution time (HCRT) (day); and 3) negative conversion (%) of SARS-CoV-2 RNA at the end of treatment. The study end date is published as February 28, 2021.
Hence, in this study, the patients were given either the approved drug Carrimycin or one of the active controls of either lopinavir/ritonavir or chloroquine. We include the study’s informed consent form.
This study attracted a lot of interest from some prominent center in China. With a pandemic now raging, medical professionals worldwide sought to get involved and do whatever is possible to help find a treatment. Participating research centers include:
- 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
According to the Chinese Trial Registry, the funder of this study is the national government’s Ministry of Science and Technology of the People’s Republic of China.
Professor Yiguang Wang, Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences, one of the developers of the product
Ronghua Jin, Principal Investigator, Beijing You’an Hospital, Capital Medical University
Call to Action: TrialSite News will reach out to try to secure some updates on this study. If others are interested, let us know—the more support the better!