Baden LR, Rubin EJ Covid-19 - The Search for Effective Therapy. N Engl J Med. 2020 May 7;382(19):1851-1852. doi: 10.1056/NEJMe2005477. Epub 2020 Mar 18.
Cao J, Hu X, Cheng W, Yu L, Tu WJ, Liu Q Clinical features and short-term outcomes of 18 patients with corona virus disease 2019 in intensive care unit. Intensive Care Med. 2020 May;46(5):851-853. doi: 10.1007/s00134-020-05987-7. Epub 2020 Mar 2. Erratum in: Intensive Care Med. 2020 Apr 14;:.
Casadevall A, Pirofski LA The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003.
Casadevall A, Scharff MD Return to the past: the case for antibody-based therapies in infectious diseases. Clin Infect Dis. 1995 Jul;21(1):150-61. Review.
Casadevall A Passive antibody therapies: progress and continuing challenges. Clin Immunol. 1999 Oct;93(1):5-15. Review.
Crowe JE Jr, Firestone CY, Murphy BR Passively acquired antibodies suppress humoral but not cell-mediated immunity in mice immunized with live attenuated respiratory syncytial virus vaccines. J Immunol. 2001 Oct 1;167(7):3910-8.
Cui J, Li F, Shi ZL Origin and evolution of pathogenic coronaviruses. Nat Rev Microbiol. 2019 Mar;17(3):181-192. doi: 10.1038/s41579-018-0118-9. Review.
Del Rio C, Malani PN COVID-19-New Insights on a Rapidly Changing Epidemic. JAMA. 2020 Apr 14;323(14):1339-1340. doi: 10.1001/jama.2020.3072.
Dresser R Research Involving Persons with Mental Disabilities: A Review of Policy Issues and Proposals. Rockville: U.S. Government Printing Office; 1998:5-28.
Fauci AS, Lane HC, Redfield RR Covid-19 - Navigating the Uncharted. N Engl J Med. 2020 Mar 26;382(13):1268-1269. doi: 10.1056/NEJMe2002387. Epub 2020 Feb 28.
National Bioethics Advisory Commitee (NBAC) Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. U.S. Government Printing Office; 1998.
Niewiesk S Maternal antibodies: clinical significance, mechanism of interference with immune responses, and possible vaccination strategies. Front Immunol. 2014 Sep 16;5:446. doi: 10.3389/fimmu.2014.00446. eCollection 2014. Review.
Wang Y, Liu Y, Liu L, Wang X, Luo N, Li L Clinical Outcomes in 55 Patients With Severe Acute Respiratory Syndrome Coronavirus 2 Who Were Asymptomatic at Hospital Admission in Shenzhen, China. J Infect Dis. 2020 May 11;221(11):1770-1774. doi: 10.1093/infdis/jiaa119.
Whitehead J Sample size calculations for ordered categorical data. Stat Med. 1993 Dec 30;12(24):2257-71. Erratum in: Stat Med 1994 Apr 30;13(8):871.
Wilson N, Kvalsvig A, Barnard LT, Baker MG Case-Fatality Risk Estimates for COVID-19 Calculated by Using a Lag Time for Fatality. Emerg Infect Dis. 2020 Jun;26(6):1339-1441. doi: 10.3201/eid2606.200320. Epub 2020 Jun 17.
Wu XX, Gao HN, Wu HB, Peng XM, Ou HL, Li LJ Successful treatment of avian-origin influenza A (H7N9) infection using convalescent plasma. Int J Infect Dis. 2015 Dec;41:3-5. doi: 10.1016/j.ijid.2015.10.009. Epub 2015 Oct 23.
Xiao AT, Gao C, Zhang S Profile of specific antibodies to SARS-CoV-2: The first report. J Infect. 2020 Jul;81(1):147-178. doi: 10.1016/j.jinf.2020.03.012. Epub 2020 Mar 21.
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.