Guest Author – Grace Guo, Technical Specialist
Remdesivir, a nucleoside analog investigation antiviral drug developed by Gilead Sciences, is being studied in several clinical trials as an experimental treatment for COVID-19. On April 29th, three clinical trials reported their results, which varies slightly depending on different rules of enrolling patients and the endpoint.
The first clinical trial that launched globally was a randomized, double-blind, placebo-controlled, and multi-center study in Hubei, China. It began enrolling patients on Feb 6th, 2020 with 237 patients involved. The result was published in The Lancet on April 29th (China study in patients with severe disease: NCT04257656). The researchers found that Remdesivir was not associated with statistically significant clinical benefits, but patients receiving the antiviral drug did have a faster time to clinical improvement than those receiving placebo.
The first clinical trial that launched in US was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) (NIAID study: NCT04280705), and they were able to also released the preliminary data analysis and result on April 29th. The data showed that there was a 31% faster time to recovery for the patient who received Remdesivir comparing to the placebo group. It also showed a lower mortality rate of 8.0% versus 11.6% for the group who received placebo.
In addition, Gilead Sciences Inc. released data on a Gilead sponsored Phase 3 simple trial in patients with severe COVID-19 disease on the same day (Gilead study in patients with severe disease: NCT04292899). It was a randomized, open-label multi-center study. The data showed that patients who received 5 days of treatment had similar clinical improvements as those who had 10 days of treatment. This data showed the suggested treatment duration for sever patients and helped to make room for other COVID-19 patients who need treatment in ICU.
The reason why those three clinical trials showed varied results is because they had different rules of enrolling patients and different endpoints. The China clinical trial had a more strict requirement for patients, which is that they had to have an interval from symptom onset to enrollment of 12 days or less. Also, the primary endpoint for China trial was the time (in days) from randomization to the point of a decline of two levels on a six-point ordinal scale of clinical status (1=discharged and 6=death). NIAID trial’s primary endpoint was time to recovery, which was defined as being well enough for hospital discharge or returning to normal activity level. On May 1st, U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for Remdesivir to treat hospitalized patients with severe COVID-19 virus.
How does Phenomenex fit into all of this?
Phenomenex HPLC preparative columns (ex. AXIA™) and silica gel flash columns (ex. Claricep™) can help to separate and purify compounds during the synthesis of different pro-drugs and intermediates. Also, the Kinetex® C18, 2.6 μm, 100 ×4.6 mm (Part No. 00D-4462-E0) is recommended to be used in QC for purity assessment during the whole synthesis process of Remdesivir.
Phenomenex was able to run a technical application focusing on the significance of HPLC in the development and production of Remdesivir. You can read more about it in this link or image below: Significance of HPLC in Development and Products of the Antiviral Drug Remdesivir
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