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A Message from LINK-J's Chairperson

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Chairman of the Board Hideyuki Okano
As the COVID-19 pandemic continues to spread rapidly, the well-being, healthcare, economy, and daily lives of people all around the world are undergoing significant changes. Under these circumstances, we have been flooded with a deluge of information on COVID-19 through Internet, social media, and media reports. In the midst of this "infodemic" where much of the information being circulated is false, the ability to grasp accurate information backed by science without being overwhelmed is essential for overcoming the threat of this virus. LINK-J considers it an important mission of ours to bring together as many people as possible in an organic manner even during a crisis. Therefore, we have decided to share information related to the novel coronavirus with everyone through this website. The content here will feature, correct methods how to prevent infection, the current R&D status on potential treatment drugs and vaccines, healthcare institutions, universities, venture companies, as well as updates on the COVID-19 situation and a summary of major publications. Through our effort to disseminate this information, we hope to come together with everyone to find a way to overcome the COVID-19 pandemic, as well as to contemplate how we can revitalize the post-coronavirus world and what the future of science, healthcare, industries, and society should look like.(April 28th, 2020)

Contents

  1. What you can do to protect you and your family from COVID-19
  2. Research and Development; medicine and vaccines
  3. Major resources for COVID-19 articles
  4. LINK-J membership medical institutions, universities and startups in action
  5. Others

1. What you can do to protect you and your family from COVID-19

COVID-19 Information and Resources (Office for Novel Coronavirus Disease Control, Cabinet Secretariat, Government of Japan)

Useful Information on the Novel Coronavirus Disease (Cabinet Public Relations Office, Cabinet Secretariat)

What you need about handwashing (Centers for Disease Control and Prevention: CDC Youtube channel)

How to wear a face covering (Ministry of Health, Labour and Welfare: MHLW Youtube channel)Japanese Only

Avoid the 3 Cs (MHLW)

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Coughing Manners (MHLW)

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2. Research and Development; medicine and vaccines

The development of medicine and vaccines is essential to overcome the COVID-19 pandemic. Currently, many projects are underway around the world through the collaboration between industries, the academia, and the government. Nevertheless, it is also imperative to verify the safety and effectiveness of these medicine and vaccines before they are used. It is important for us to keep up with the accurate current status of R&D, not worrying about the news reports.

2-1. Government support for R&D related to COVID-19

  1. Government of Japan invests +80billion JPY in Coronavirus R&D(Cabinet Secretariat, Office of Healthcare Policy)Japanese text Only
  2. Information on novel Coronavirus for research institutes, researchers, and science & technology administive agencies (Ministry of Education, Culture, Sports, Science and Technology: MEXT)Japanese text Only

  3. Support for R&D on the novel Coronavirus disease (COVID-19)(Japan Agency for Medical Research and Development: AMED)

  4. Research data and database information for SARS-CoV-2 and COVID-19   (Japan Science and Technology Agency: JST / National Bioscience Database Center: NBDC)Japanese text Only

  5. Efforts to Combat COVID-19 (Pharmaceuticals and Medical Devices Agency: PMDA)

  6. "Information on the exceptional approval process of pharmaceutical drugs for COVID-19" (published on May 12th, 2020) (PMDA)Japanese text Only

    The guidelines clearly state that all pharmaceutical drugs that can potentially treat COVID-19 have high priority to undergo the approval process. In addition, in the event that a drug demonstrates a certain level of effectiveness and safety in research carried out by public research initiatives such as those funded by the Ministry of Health, Labour and Welfare, this "may be considered legitimate grounds for the new drug application without submitting trial-related materials, e.g., the results of clinical trials" under certain conditions, as with public knowledge-based applications.

2-2. Development of drugs to treat COVID-19

This section outlines clinical trials for potential treatment drugs and vaccines that have been registered in databases. (For the latest information, access the databases directly.)

  1. Clinical trials (Japan)
    • Search Clinical Trials in Japan (National Institute of Public Health)
      As of May 7th, 2020, the following clinical trials for potential treatment drugs for COVID-19 have been registered: one Phase-3 trial for Favipiravir; one Phase-3 trial for Sarilumab; two Phase-3 trials for Remdesivir; one Phase-3 trial for Tocilizumab; one specified clinical study for the three-drug combination of Lopinavir, Ritonavir, and hydroxychloroquine; two specified clinical studies for Favipiravir; one specified clinical study for the combination of Favipiravir and Nafamostat; one investigator-initiated clinical trial for Remdesivir; and one specified clinical study for Ciclesonide.

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  2. Clinical trials (Global)(ClinicalTrials.gov)(ClinicalTrials.gov)
    Searched results with keywords 'SARS-CoV-2' 'COVID19', Disease:COVID-19, other terms:treatment

  3. Development of drugs to treat COVID-19 (ClinicalTrials.gov)
    • Abigan(favipiravir) (ClinicalTrials.gov)
    • Veklury(remdesivir) (ClinicalTrials.gov)
      On May 7th, 2020, the Minister of Health, Labor, and Welfare (MHLW) granted special approval for Veklury®︎ (remdesivir) based on Article 14-3 of the Pharmaceuticals and Medical Devices Act.(https://www.pmda.go.jp/english/int-activities/0004.pdf

      On May 1st, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization for remdesivir, which is being developed by Gilead Sciences. https://www.fda.gov/media/137564/download The remdesivir covered by this authorization will be used only to treat adults and children with suspected or laboratory confirmed COVID-19 and severe disease defined as SpO2 ≤ 94% on room air, requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO);  This Emergency Use Authorization was issued based on review of the topline data from the randomized, double-blinded, placebo-controlled trial conducted by NIAID (Japan's National Center for Global Health and Medicine collaborated) and from the Gilead-sponsored open-label trial that evaluated different durations of remdesivir, it is reasonable to believe that the known and potential benefits of RDV outweigh the known and potential risks of the drug for the treatment of patients hospitalized with severe COVID-19.  The NIAID clinical trial with hospitalized COVID-19 patients as subjects and their time to recovery as the primary endpoint. Analysis of the preliminary data of 1,063 patients showed that patients who received remdesivir had a 31% faster recovery time than the placebo group (11 days vs. 15 days, p<0.001). Patients who received remdesivir also had a lower mortality rate, which was the secondary endpoint, although the difference was not statistically significant (8.0% vs. 11.6%, p<0.059). https://www.niaid.nih.gov/news-events/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19

      Analysis of the top-line results of the nonblinded Phase-3 trial published by Gilead Sciences which evaluated the 5-day and 10-day administration of remdesivir for hospitalized patients in critical condition demonstrated the same extent of clinical improvements in both groups. According to the company, these results indicate the possibility of prescribing a 5-day treatment regimen, which could significantly increase the number of patients who can be treated with the current supply of remdesivir.

    • Hydroxychloroquine(ClinicalTrials.gov) (ClinicalTrials.gov)
    • Kaletra(Lopinavir, Ritonavir)(ClinicalTrials.gov) (ClinicalTrials.gov)
    • convalescent plasma (ClinicalTrials.gov) (ClinicalTrials.gov)

2-3. Development of vaccines to prevent COVID-19

Global regulatory workshop on COVID-19 vaccine development (International Coalition of Medicines Regulatory Authorities: ICMRA)

  • http://www.icmra.info/drupal/
    On March 18th, 2020, representatives of over 20 regulators of pharmaceutical drugs from 17 different countries gathered with experts from WHO and EC to discuss regulatory considerations pertaining to the development of potential vaccines for SARS-CoV-2 as well as the non-clinical-trial data required for launching first-in-humans (FIH) trials.
  • The Coalition for Epidemic Preparedness Innovation: CEPI
    CEPI (Coalition for Epidemic Preparedness Innovations) is a partnership between governments and private sectors that was launched at the WEF conference in Davos in January 2017 with the aim of promoting vaccine development through global collaboration. The Japanese government is also a contributor of CEPI funding. CEPI has requested contributions from governments for the development of a COVID-19 vaccine. Its goal is to raise US$2 billion in funds, of which it has raised US$765 million to date. So far, it has launched partnerships with eight vaccine development companies, etc. (as of April 16th, 2020)

2-4. Assay techniques and Test Development for COVID-19

  1. Information on genetic tests for SARS-CoV-2
  2. Preliminary study on the performance of four different detection kits for SARS-CoV-2 antibodies (The Japanese Association for Infectious Diseases)Japanese text Only

3. Major resources for COVID-19 articles

  1. Articles of clinical trials and studies for drugs to treat COVID-19 (National Institute of Health Sciences)

    English written articles that report the results of clinical trials and in-vitro studies for hydroxychloroquine, Lopinavir/Ritonavir (Kaletra®), Remdesivir, Favipiravir (Avigan®), and convalescent plasma therapy. There are some articles that have not been peer-reviewed.

  2. Springer Nature
  3. Global Health & Medicine
  4. The NEW ENGLAND JOURNAL of MEDICINE
  5. Inflammation and Regeneration
  6. National Institutes for Health (NIH)
  7. Annals of Internal Medicine
  8. British Medical Journal (BMJ)
  9. THE LANCET
  10. The Journal of the American Medical Association
  11. CellPress

4. LINK-J membership medical institutions, universities and startups in action

  • Nanosponges Could Intercept Coronavirus Infection(UC San Diego)
  • Coronavirus Resource Center(BIOCOM)

Check our Bulletin board for our members' COVID-19 news.

LINK-J calls for COVID-19 information from our members. Click here to post your information.

5. Others

Current state of the COVID-19 pandemic
The number of new cases and total number of cases are being reported on a daily basis through media reports. Although the ultimate determination on how we should handle an infectious disease should be based on its mortality rate instead of the number of cases, the data on the number of cases is useful for predicting whether and when the current explosive spike in cases will give way to a containment phase.
Trajectory of COVID-19 Confirmed Cases

COVID-19 situation in different countries. While it is difficult to make a direct comparison between different countries due to differences in COVID-19 testing guidelines and diagnostic criteria, successful infection control after an exponential spike in cases as represented by the straight line will present as a sharp decrease in the number of new cases thereafter.

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