StemCell Therapy

Welcome to the Regulatory Focus COVID-19 Therapeutics Tracker, your go-to resource for information on developing COVID-19 treatment candidates.As COVID-19 continues to spread around the globe, researchers and manufacturers are moving potential therapeutics into clinical trials at a dizzying pace.In the US, funding is led by the National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health (NIH), while some companies also are funding their own COVID-19 research. Internationally, the UK Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) have called for targeted efforts to develop therapies against COVID-19.While no specifically approved treatments, stakeholders are looking to repurpose approved drugs that have worked against similar coronaviruses in the past or are hypothesized to attack or immobilize SARS-CoV-2 based on the mechanism of action. Plasma and stem cells from patients who have recovered from COVID-19 also are being investigated.This tracker will be updated weekly with the latest in developments for these treatment candidates.Investigational candidates for COVID-19Drug: RemdesivirMedication class: AntiviralDeveloper: Gilead SciencesOriginal use: Treatment for Ebola and Marburg virus infectionsRationale: Remdesivir, an intravenous drug that inhibits viral replication, has shown in vitro and in vivo activity against SARS-CoV-2. It was originally developed as a treatment for Ebola that ultimately proved less effective than other therapies, but has shown effectiveness in animal studies against other coronaviruses.Trials: Two Phase 3 trials in China from Capital Medical University looking at mild and moderate (NCT04252664) and severe COVID-19 cases (NCT04257656); the Phase 3 ACTT trial from National Institute of Allergy and Infectious Diseases (NIAID); two phase 3 international studies from Gilead examining moderate (NCT04292730) and severe COVID-19 cases (NCT04292899); and a treatment arm of the World Health Organization (WHO) SOLIDARITY trial.Status: All Phase 3 trials except SOLIDARITY are currently recruiting. Capital Medical Universitys trials are expected to be completed in late April and early May 2020. Gilead Sciences international trials have an estimated study completion date of May 2020. NIAIDs trial is recruiting, with an estimated completion date in April 2023.

Therapy: Convalescent plasmaMedication class: ImmunoglobulinRationale: Researchers have theorized that convalescent plasma could be used as passive immunotherapy in other coronaviruses such as MERS and in SARS-CoV-2 to help neutralize the virus.Trials: Eight studies in China examining inactivated convalescent plasma are in various stages, both recruiting and not recruiting.Outcome: Preliminary findings indicate convalescent plasma may be beneficial for patients with COVID-19. A case series of 5 patients in China with COVID-19 and acute respiratory distress syndrome treated with convalescent plasma showed the therapy improved their clinical status.Status: On 24 March, the FDA allowed the use of convalescent plasma from recovered cases of COVID-19 as an emergency investigational new drug (eIND) for patients with serious or immediately life-threatening COVID-19 infections.

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COVID-19 Therapeutics Tracker - Regulatory Focus

This entry was posted on March 31, 2020 at 5:50 am and is filed under Stem Cell Complications. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |