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In the US, use of the Mitra device with blood is limited to research and non-diagnostic applications. In many countries outside the US, the Mitra device is approved as a remote blood sample collection device for some clinical applications, as referenced in some content.

hydroxychloroquine to treat COVID-19: at-home specimen collection examined

by Neoteryx | 4 min read

At the beginning of April 2020, it was reported by Johns Hopkins University that the number of COVID-19 infections had surpassed the 1 million mark globally, and the number of cases was still rising. In the face of the devastating novel coronavirus that causes COVID-19 infections, the race is on to find effective treatments as well as an effective vaccine.

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Treatments being investigated include a trial in New York, where plasma enriched in antibodies from recently recovered patients was given to newly infected patients, in an attempt to assist their immune systems in making their own antibodies. Other potential treatments include repurposing antiviral drugs and others designed to help inhibit the immune system from overreacting to foreign invaders, including viruses. This overreactive response is called a cytokine storm, which in some patients can cause sepsis that results in organ failure, or even death.

Investigating Hydroxychloroquine as a Possible Treatment for COVID-19

Of all the potential treatments that have been highlighted in the popular press, the prophylactic antimalarial drugs Chloroquine (CQ) and Hydroxychloroquine (HCQ) are creating the most buzz. According to a review from The Centre for Evidence-Based Medicine (CEBM) at Oxford University (UK) on the current clinical evidence, there appears to be a growing and encouraging dataset that indicates these drugs may help. However, the CEBM review emphasizes that the firm science around the efficacy that these antimalarials have on treating COVID-19 is not yet confirmed. More research is needed before scientists recommend the wide-spread use of CQ and HCQ as a COVID-19 therapy.

Hydroxychloroquine: Proposed Modes of Action

There appears to be a number of potential modes of action against the SARS-CoV-2 virus to treat those suffering with COVID-19. According to the CEMB review, one mode of action is that CQ and HCQ could inhibit viral cell binding by reducing glycosylation of angiotensin converting enzyme 2. Another mode is inhibition of proinflammatory cytokines, which would prevent the aforementioned cytokine storms. Researchers report that CQ also appears to accumulate in lysosomes, which could prevent the virus from causing endosome rupture, thus reducing cellular viral spread.

At-Home Specimen Collection: A Safer Way to Prove Efficacy of COVID-19 Treatments

As COVID-19 cases continue to multiply at a worrying rate, the need to conduct rapid but safe clinical trials is paramount. One way to achieve this is by running virtual clinical trials in which remote specimen collection options are provided to people. They can use at-home collection kits to self-collect specimens. People can then send their samples back in the regular mail. The samples collected with at-home kits from Neoteryx utilize volumetric absorptive microsampling (VAMS) technology, which enables precise and validated analysis.

At-home collection kits from Neoteryx are currently being used to conduct COVID-19 studies, and new studies are launching every day. In fact, the National Institutes of Health (NIH) announced the use of Mitra® microsamplers from Neoteryx for a large study of COVID-19 immunity. NIH researchers are confident in using these remote microsamplers because, for a number of years, Mitra microsampling has been used in worldwide clinical trials. Last year for example, UCB Biopharmaceuticals announced at the EUMED conference that they implement the Neoteryx remote microsamplers in their worldwide drug trials.

Established Use of Mitra & VAMS Microsamplers in a Hydroxychloroquine Bridging Study for RA patients

In 2017, a clinical bridging study was conducted on HCQ and its metabolites by researchers focused on improving Rheumatoid Arthritis (RA) care in the US. It has been observed that CQ and HCQ, are not only effective against malaria, they are also effective against autoimmune diseases and are used as a treatment for Lupus and RA. Unfortunately, it has been reported that medical adherence of HCQ is quite poor. Indeed, out of 750,000 patients taking HCQ it has been estimated (2016) that only 50% of patients have beneficial circulating levels of the drug. Therefore, it was proposed that regular therapeutic drug monitoring of HCQ could improve adherence levels and improve outcomes.

The 2017 paper, published by Ying Qu et al, reported on how they conducted a bridging study. Fifty-four HCQ patients from a wide demographic participated in the study. The results were very promising, and the study authors report that the Deming regression analysis indicated that the concentrations of HCQ and its metabolites in remote microsamples correlated exactly with those found in venous blood. They also reported that the HCQ and its metabolites were stable at ambient temperature for up to 10 days on the Mitra microsamplers. Moreover, the samples were shown to be stable at 50 °C when incubated for 24 hours.

Conclusions

Qu and co-investigators concluded that the Mitra with VAMS samplers could be used to remotely collect bio-fluids for Therapeutic Drug Monitoring (TDM), and concentrations of HCQ. Their conclusions mirror many examples in the literature reporting similar results using Mitra devices. These examples show that using Mitra with VAMS technology for remote microsampling is a practical option for a broad range of studies. Therefore, an at-home specimen collection option that is self-managed by remote study participants is a promising alternative for those looking to embark on virtual clinical trials exploring COVID-19 therapies during the Coronavirus Pandemic and beyond.

Topics: Viral Pathogens, Remote Patient Monitoring, COVID-19

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Sources

https://www.niaid.nih.gov/news-events/nih-begins-study-quantify-undetected-cases-coronavirus-infection

https://www.bbc.co.uk/news/world-52144390

https://news.sky.com/story/coronavirus-new-york-trials-experimental-treatment-with-recovered-patients-blood-11962651

https://www.cebm.net/covid-19/chloroquine-and-hydroxychloroquine-current-evidence-for-their-effectiveness-in-treating-covid-19/

https://www.eufemed.eu/wp-content/uploads/3.5-Chanteux-with-video-1.pdf

https://www.sciencedirect.com/science/article/abs/pii/S0731708517301528

https://www.exagen.com/wp-content/uploads/Exagen-Diagnostics-Announces-Release-of-Novel-Test-to-Empower-Patients-161003.pdf 

 

 

 

 

Originally published Apr 13, 2020 10:00:00 AM, updated on February 15, 2021

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