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Many patients who die from COVID-19 have blood clots forming in the smallest blood vessels.
also show blood clots in young COVID-19 patients that can lead to stroke, heart attacks and other potentially fatal complications.
to address these challenges, the ACTIV-4 program was launched.
National Institutes of Health (NIH) recently launched two Phase 3 clinical trials to determine whether anticoagulant drugs can help improve the health of PATIENTs with COVID-19.
project, known as the "ACTIV-4 antithrombosis drug" trial, will test heparin and other anticoagulant drugs to help patients with severe COVID-19 conditions, as well as those with mild or discharged conditions.
BMS and Pfizer will donate Eliquis and aspirin for trial use to the study, as well as other drugs.
the program, known as the ACTIV-4-Antithrombosis Program, is the fourth large-scale pilot program initiated by the National Institutes of Health (NIH) in a partnership with 20 biopharmaceutical and biotechnology companies.
other current research programs are testing engineered antibodies and immunomodulation drugs.
's ACTIV Partner Program, established in April this year, uses a "master protocol" approach through public-private partnerships, while evaluating multiple drugs and adjusting trial designs in a timely manner;
research projects covered by the ATCTIV program include testing immunomodulation drugs such as Lilly's Olumiant, based on Gilead Sciences' antiviral drug, Redsyvir.
second and third programs were launched in August this year to assess the effects of engineered antibody drugs on patients with mild, moderate or severe COVID-19.
the launch of the ACTIV-4 program in response to the deadly clotting problems in patients with COVID-19.
a study of 2,773 patients published last month in the Journal of the American College of Cardiology by researchers from the Icahn School of Medicine in Mount Sinai suggested that anticoagulant drugs may help patients with symptoms.
but there is no clear evidence to support the use of these drugs.
there is also a lack of understanding of which patients will benefit the most, when they should be treated, and which medications should be taken with the appropriate dose.
ACTIV-4 research program includes three trials for hospitalized COVID-19 patients, COVID-19 patients who do not need to be hospitalized, and COVID-19 patients who have been discharged.
more than 100 test sites worldwide will participate in the ACTIV-4 research program.
photo source: Reference : Inpatients will receive low or high doses of generic heparin, which is used to prevent or reduce blood clot formation.
non-hospitalized patients will be given a placebo, aspirin, or low-dose apixaban.
researchers will assess whether these treatments can reduce potentially fatal heart or lung disease.
who are discharged from the hospital will receive anticoagulant drugs that have not yet been specified, in the hope of reducing the risk of heart disease, stroke, or other complications within 45 days of discharge.
research progresses, research institutions may stop using some of these drugs or use different combinations of therapies.
researchers will also take blood samples from patients for clues to patients at high risk of complications.
Francis Collins, director of the
NIH, said in a statement that there is currently no standard of care for anticoagulant therapy for hospitalized COVID-19 patients and that clinical evidence is urgently needed to support specific medical norms.
trials for patients with COVID-19 who have been discharged from hospital have not yet started, niH said the study would begin "later" but did not mention a specific start date.
References: . . . . . . . . . . . . . . . . . . . . . NIH ACTIV initiative launcheses adaptive clinical trials of blood-clotting treatments for COVID-19. Sept 10, 2002. Retrieved Sept 12, 2020 from Ben Fidler. NIH spearheads broad partnership with drugmakers, regulators to speed COVID-19 therapies. Apr 17, 2020. Retrieved Apr 20, 2020 from Therapeutics Accelerator. Advancing research into accessible coronavirus treatments. Retrieved Sept 12, 2020 from Jocelyn Kaiser. To streamline coronavirus vaccine and drug efforts, NIH and firms join forces. Apr 17, 2020. Retrieved Apr 18, 2020 from Drug Ming Kant Content Team. Try this sharp Swiss Army knife to solve the problem of clinical trials of COVID-19 drugs. Apr 20, 2020. Retrieved Apr 20, 2020 from Crystal Phend. Blood Thinners Again Linked to COVID-19 Survival in Hospital. Aug 26, 2020. Retrieved Aug 27, 2020 from Ben Fidler. NIH starts broad set of studies testing blood thinners against COVID-19. Sept 11, 2020. Retrieved Sept 12, 2020 from LAUREN MARTZ. Master protocols emerge as a critical clinical tool against COVID-19. Apr 11, 2020. Retrieved Apr 12, 2020 from the public number of WeChat.