The Coronavirus Clinical Trial Landscape
The Coronavirus Clinical Trial Landscape: The first known case of pneumonia due to an unknown cause was reported to the World Health Organization (WHO) office in China on December 31, 2019. It happened in Wuhan, Hubei Province.
This mysterious respiratory syndrome was later identified, and the etiological pathogen was named a new type of coronavirus on January 7, 2020. Following this, the medical world entered clinical trials and research to discover a new drug to fight this virus.
The role of translational research
Translational research applies knowledge from biology and clinical studies to tools and techniques that meet critical medical needs. In contrast to the applied sciences translational research is specially formulated to improve health outcomes.
This method employs a team of experts who focus on translating useful data from research laboratories to doctor’s offices and hospitals. This is followed by a “bench to bed” model.
This method serves as an aid for clinical studies. Several mammalian species and naturally occurring diseases are studied in veterinary clinical studies. This method ensures a quick medical solution for veterinary cases while helping in the development of human medicines.
To date, Coronavirus 2, an acute respiratory syndrome, has caused approximately 38 million cases of COVID-19, a disease that killed 1,083,234 people worldwide in a short period of time.
The coronavirus outbreak poses a challenge to the scientific community worldwide. They are able to expedite the development and testing of new treatments and vaccines to end this pandemic.
The efficacy and safety of small molecule drugs has been contested in over 2,000 clinical studies conducted from the start of the pandemic through July 2020. There are four web-based clinical trial databases that register these trials for the treatment of COVID-19.
These numbers show the extent of the ongoing global effort to combat this challenging disease. Efforts to develop vaccines also meet needs.
Over 180 investigated drug applicants are registered in more than one clinical study. They are tested either alone or in combination with other drugs.
The possibilities for repositioning medicines
These low molecular weight drug tests reveal an interesting chemical diversity. It highlights the significant role of the drug repositioning method in clinical trials for the treatment of COVID-19.
Repositioning drugs is a chemical strategy in medicine. It is used to identify new uses for existing approved drugs. It also includes candidates in advanced clinical research. One of the key benefits of drug repositioning is the minimal development time since preclinical and clinical exams.
Both in animals and in humans as well as formulation and production processes on an industrial scale have already been successfully completed. Although relatively less well known to the public, drug repositioning has a long history in drug discovery.
For example, the drug zidovudine (ZDV or AZT) manufactured in 1964 was originally developed for the treatment of cancer. It was effectively and successfully converted and in 1987 it was approved as the first drug for the treatment of HIV / AIDS.
Similarly, sildenafil, or Viagra, was originally developed to treat coronary disease in the 1980s. It later became the first effective oral erectile dysfunction treatment.
So far, combination therapy has been considered more effective and convenient in treating COVID-19 because of the low efficacy of current clinical candidates. Treatment for HIV-AIDS is a well-known example of this strategy.
A mixture of antiretroviral drugs is essential to control the replication of the virus. It also improved the patient’s conditions clinically. Studies show that patients who strictly adhere to extremely active antiretroviral therapy (HAART) live normally within the constraints imposed by lifelong treatment.
Potential drug candidates
So far, no specific vaccine or drug for COVID-19 has been officially approved by regulatory agencies such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Health Products Regulatory Authority (MHRA).
Favipiravir, an antiviral drug, was recently approved in Russia for the treatment of COVID-19. The drug has been studied in 25 medical studies registered on ClinicalTrials.gov.
However, to date there is no convincing scientific evidence of effectiveness against this disease.
Another controversial issue is the ineffectiveness of chloroquine and hydroxychloroquine. These anti-malarial drugs rank first in the number of ongoing clinical trials worldwide.
Although they have more than 220 records on ClinicalTrials.gov, the effectiveness of these drugs for COVID-19 has never been proven.
The Food and Drug Administration (FDA) revoked the use of hydroxychloroquine and chloroquine on June 15, 2020. As there is no reliable scientific evidence of its effectiveness in treating COVID-19 patients with mild, moderate, or severe manifestations.
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The Coronavirus Clinical Trial Landscape
Coronavirus clinical studies