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Clinical Trials for Covid-19 – update #1

COVID-19, the new disease caused by SARS-CoV-2, a newly identified virus since the beginning of December 2019 is terrifying every country in the world. Since January 2020 almost 430,000 people have fallen ill and more than 19,000 have died.

Scientists and clinicians are still trying to figure out how to deal with this virus and to create a new drug or vaccine which could help in the fight against it. Across the globe, an unprecedented volume of clinical trials focused on both potential treatment and vaccination against COVID-19 have been planned or initiated in the hope of helping those affected. This, however, is just the beginning with more and more trials planned daily and at the time of this article, a similar volume of trials are in the planning stage.

At Pratia, with the leading Site Network, we follow clinical research activities with COVID-19 and the ways of dealing with it by constantly looking for new sources of reliable information. Read a summary of the most interesting discoveries on the COVID-19:

  •  In recent days, a group of scientists led by Professor Katherine Kedzierska from Australia has announced the results of a study detailing how the immune system responds to COVID-19 in mild to moderate disease states which require hospitalization. They have shown the kinetics of immune responses concerning the clinical and virological features of a patient. According to them, the key role of the body’s immune response to SARS-CoV-3 has got the increasing level of antibody-secreting cells, follicular helper T cells, activated CD4+ T cells and CD8+ T cells and immunoglobulin M (IgM) and IgG antibodies. The changes in levels of them were detected in blood before symptomatic recovery. One of the most important cells is ASCs – antibody-secreting cells which are key for the rapid production of antibodies following infection with Ebola virus and infection with and vaccination against the influenza virus. By infection with SARS-CoV-2, ASCs appeared in the blood at the time of viral clearance and increased day by day.
  • mRNA-1273 is the first human vaccine against SARS-CoV-2 entering testing by ModernaTX Inc. The first 45 patients who have been vaccinated in recent days are reported to be in very good health. The vaccine has been projected as a novel lipid nanoparticle (LNP) – an encapsulated mRNA-based vaccine that encodes the full length, prefusion stabilized spike (S) protein of the virus, because of the S and N proteins as these are known to induce potent and long-lived responses in SARS-CoV. In the Phase 1 study which is evaluating the safety and immunogenicity, the patients got three dose levels of vaccine (25, 100, 250 ug), administered on a two-dose vaccination schedule, given 28 days apart. All of the participants of the study will be followed through 12 months after the second vaccination. The primary objective of scientists is to evaluate the safety and reactogenicity of vaccination of mRNA-1273. The second goal is to evaluate the immunogenicity of the SARS-CoV-2 S protein.
    • Right now on ClinicalTrials.gov, there are 4 other trials on vaccines – Each of them is step by step closer to test it on humans and to be the prevention against newly identified coronavirus. Two of them are based on the minigene vaccine and one on the recombinant adenovirus type 5 vector. The closest time will show which vaccine has a chance to be the protection against this new coronavirus.
  • Are hydroxychloroquine and azithromycin the key to solving the treatment conundrum for patients with COVID-19? This hot topic began after information from the French lab of The Mediterranee Infection University Hospital Institute in Marseille emerged. The scientists from this University found that currently reported data showed these two long-standing drugs could give a new chance at managing symptoms and potentially allow patients to recover. The experiments were carried out on 36 patients (6 were asymptomatic, 22 had upper respiratory tract infection symptoms and 8 had lower respiratory tract infection symptoms). Twenty cases were treated with hydroxychloroquine in this study and showed a significant reduction of the viral load carriage at day 6 post inclusion compared to the controls. Furthermore, azithromycin added to hydroxychloroquine was significantly efficient for virus elimination.

We at Pratia are interested in sharing reliable information that could help us, our patients and partners in the fight against COVID-19!

In our sites we are maintaining operations to proceed with medical innovation, re-evaluating the model we work with and putting significant attention to the safety of our patients, employees, clients and our families.

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