COVID-19 — PAxlovid loNg cOvid-19 pRevention triAl With recruitMent In the Community in Norway
Citation(s)
Blomberg B, Cox RJ, Langeland N Long COVID: A growing problem in need of intervention. Cell Rep Med. 2022 Feb 14;3(3):100552. doi: 10.1016/j.xcrm.2022.100552. eCollection 2022 Mar 15.
Cevik M, Tate M, Lloyd O, Maraolo AE, Schafers J, Ho A SARS-CoV-2, SARS-CoV, and MERS-CoV viral load dynamics, duration of viral shedding, and infectiousness: a systematic review and meta-analysis. Lancet Microbe. 2021 Jan;2(1):e13-e22. doi: 10.1016/S2666-5247(20)30172-5. Epub 2020 Nov 19.
Kim PS, Read SW, Fauci AS Therapy for Early COVID-19: A Critical Need. JAMA. 2020 Dec 1;324(21):2149-2150. doi: 10.1001/jama.2020.22813. No abstract available.
Laouenan C, Guedj J, Mentre F Clinical trial simulation to evaluate power to compare the antiviral effectiveness of two hepatitis C protease inhibitors using nonlinear mixed effect models: a viral kinetic approach. BMC Med Res Methodol. 2013 Apr 25;13:60. doi: 10.1186/1471-2288-13-60.
Stokel-Walker C The search for antivirals for covid-19. BMJ. 2021 Sep 20;374:n2165. doi: 10.1136/bmj.n2165. No abstract available.
PAxlovid loNg cOvid-19 pRevention triAl With recruitMent In the Community in Norway
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
