hydroxychloroquine to treat COVID-19: at-home blood collection examined
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 Coronavirus pandemic that is causing the COVID-19 infections, the race is on to find effective treatments as well as an effective vaccine.
Treatments being investigated include a trial now underway in New York, where plasma enriched in antibodies from recently recovered patients is being 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 showing the most promise and getting 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. They 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 Blood 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 lab testing and clinical trials is paramount. One way to achieve this is by running virtual clinical trials in which remote blood sampling is provided to patients so they can use at-home blood collection kits to collect capillary blood specimens themselves. Patients can then send their dried blood samples back to a laboratory in the regular mail. The blood samples collected with at-home kits from Neoteryx utilize volumetric absorptive microsampling (VAMS) technology, which enables precise and validated testing to occur in the lab.
At-home blood collection kits from Neoteryx are currently being used by labs to conduct COVID-19 testing, and new studies are launching every day. In fact, the National Institutes of Health (NIH) have just 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 now, Mitra microsampling has been used in worldwide clinical trials. Last year for example, UCB Biopharmaceuticals announced at the EUMED conference that they are implementing 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 in treating 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 between venous blood and capillary blood using 10 uL Mitra microsamplers with VAMS that employ easy-to-use tips for sampling small amounts of blood. Fifty-four HCQ patients from a wide demographic participated in the study. A majority (44) of the patients were also asked to sample their blood onto DBS cards for comparison.
The DBS method proved problematic, because 20% of the patients failed to produce enough blood to fill the 6mm-diameter spots on the DBS cards; compared to all patients able to sample successfully with the Mitra microsampling devices. 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 capillary blood 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 blood samples were shown to be stable at 50 °C when incubated for 24 hours.
Qu and co-investigators concluded that the Mitra with VAMS samplers could be used to collect blood by fingerpick for Therapeutic Drug Monitoring (TDM), and concentrations of HCQ and its metabolites were comparable to those measured in venous blood. These conclusions, mirror many examples in the literature reporting similar results using Mitra, comparing it to venous blood draws. 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 blood collection option that is self-managed by remote patients is a promising alternative for those looking to embark on virtual clinical trials exploring COVID-19 therapies during the Coronavirus pandemic and beyond.