Publication Information

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609, 1895], 'infections': [546, 562, 610, 1893], '(4).': [547], 'Concentrated,': [548], 'virus-specific': [549], 'immunoglobulin': [550, 1885, 3118], 'preparations': [551], 'postexposure': [557], 'prophylaxis': [558], 'such': [560, 1618], 'as': [563, 852, 1376], 'hepatitis': [564], 'B,': [565], 'varicella,': [566], 'rabies': [568], '(5).': [569], 'Recently,': [570], 'randomized': [572, 1121, 2049], 'controlled': [573, 1849, 2372, 3280], 'trial': [574, 1850], '(RCT)': [575], 'demonstrated': [576, 1633], '2': [580, 878, 1935], 'different': [581, 3094], 'monoclonal': [582], 'antibody': [583, 866, 1232], 'Ebola': [587, 633, 1438, 1852, 1996, 2262], 'virus': [588, 634, 1853, 1997], '(6).The': [590], 'situation': [591], 'is': [592, 763, 1217, 1388, 1585, 1615, 1683, 2348, 2352], 'less': [593], 'clear': [594], 'regarding': [595, 804], 'plasma,': [602, 809, 1449, 1490], 'which': [603, 1255], 'been': [605, 783], 'from': [611, 792, 1119, 1184, 1190, 1237, 1242, 3187, 3251, 3448], '1918': [613], 'influenza': [614], 'recent': [618], 'epidemics': [619], 'severe': [621, 711, 1890, 1929, 3258], 'acute': [622, 1891], 'respiratory': [623, 630, 1892, 1964], 'syndrome': [624], '(SARS),': [625], 'H1N1': [626], 'influenza,': [627], 'Middle': [628, 1962], 'East': [629, 1963], 'syndrome,': [631], '(7–10).': [636], 'only': [638, 1284], 'RCT': [639], 'demonstrating': [640], 'infectious': [647], 'was': [649, 668, 729, 742, 981, 1064, 1431, 3042, 3338], 'conducted': [650], 'more': [651], 'than': [652, 961, 1188], '40': [653], 'years': [654, 963], 'ago,': [655], 'Argentine': [658, 2025], 'hemorrhagic': [659], 'fever': [660, 2027], '(11).Early': [661], 'in': [662, 670, 685, 690, 731, 778, 888, 903, 908, 1066, 1072, 1097, 1178, 1213, 1234, 1261, 1440, 1550, 1799, 1961, 1999, 2022, 2236, 2309, 2446, 3083, 3123, 3156, 3225, 3237, 3254, 3263, 3290, 3335, 3390, 3441, 3443, 3456], 'pandemic,': [665, 1609], 'China': [671], 'hospitalized': [674, 2167, 2310, 3147, 3256], 'patients': [675, 686, 829, 893, 912, 919, 957, 1044, 1098, 1238, 1280, 1288, 1568, 2168, 2311, 3086, 3149, 3190, 3255], '(7).': [678], 'Shortly': [679], 'thereafter,': [680], 'RCTs': [681, 774, 1310, 1345, 1470, 1518, 1535, 1614], 'evaluating': [682], 'began': [689], 'several': [691, 1205, 1445], 'countries,': [692], 'including': [693, 1116, 1207, 1447, 1671], 'United': [695, 780], 'States': [696, 781], '(12).': [697], 'March': [699], 'authorized': [703], 'expanded': [704], 'life-threatening': [713], 'under': [715], 'individual-patient': [716], 'Investigational': [718, 2106], 'applications.': [721], 'Mayo': [723, 815, 995, 1084, 2064], "Clinic's": [724], 'Expanded': [725, 1554, 2066, 2103], 'Access': [726, 1555, 2104], 'Program': [727], '(EAP)': [728], 'developed': [730], 'parallel': [732], 'provide': [734, 1521, 1564, 1696], 'broader': [735], 'plasma;': [739], 'however,': [740], 'it': [741, 765, 1375, 2405], 'designed': [744, 1517], 'generate': [746, 1594, 1691], 'definitive': [747, 1522], 'data': [748, 791, 1118, 1150, 1200, 1326], 'evaluate': [753], '(13).': [755], 'One': [756], 'requirements': [759], 'EAP': [762, 825, 1019, 1149, 1199, 1279, 1294, 1303], 'interfere': [767], 'pivotal': [769], 'trials': [770, 1122, 2050, 2373, 3281], '(14).': [771], 'Adequately': [772], 'powered': [773, 794, 1344, 1613], 'have': [782, 841, 1240, 1366, 1506, 1573, 2387], 'slow': [784], 'enroll': [786], 'patients.Given': [787], 'lack': [789, 1166, 1530], 'properly': [793, 1516], 'RCTs,': [795], 'need': [798], 'inform': [800], 'regulatory': [801], 'decision': [802], 'making': [803], 'continued': [805], 'both': [810], 'Clinic': [816, 996, 1085], 'performed': [817], 'retrospective,': [818], 'indirect': [819], 'evaluations': [820], 'using': [824, 874, 1030], 'data,': [826, 1115], 'hypothesizing': [827], 'who': [830, 894, 899, 913, 929, 942, 958, 975, 1000, 1013, 1099, 1239, 1289, 1569], 'received': [831, 895, 900, 930, 943, 976, 1002, 1015, 1100, 1290], 'units': [833], 'higher': [835], 'titers': [836, 867, 1026, 1233], 'neutralizing': [838, 865, 1228, 3108, 3249], 'antibodies': [839, 3109, 3223, 3250], 'would': [840, 2397, 2409], 'better': [842], 'clinical': [843, 1580, 3116], 'outcomes.': [844], 'results': [846], 'analyses': [849, 1089, 1146, 1250, 1273, 1300], 'were': [850, 868, 914, 959, 1027, 1041, 1450], 'supporting': [853], 'EUA.The': [857], 'analysis': [859, 884, 954, 992, 1677], 'included': [860, 997], '4330': [861], 'patients,': [862], 'donor': [864], 'measured': [869, 1028], 'Broad': [872], 'Institute,': [873], 'SARS': [876, 3362, 3486], '(SARS-CoV-2)': [879, 3420], 'neutralization': [880], 'assay': [881, 1035], '(15).': [882], 'revealed': [885], 'difference': [887, 1077], '7-day': [889, 971], 'mortality': [890, 972, 1062, 2165, 3144], 'high-titer': [896, 931, 1051, 1074, 1095, 1191], 'those': [898, 924, 928, 974, 1423], 'low-titer': [901, 944, 979, 1068, 1185], 'overall': [905], 'population': [906], 'subset': [910, 1277], 'intubated.': [915], 'However,': [916], 'among': [917, 1008, 1043, 1649, 2166, 3189], 'nonintubated': [918, 956], '(approximately': [920], 'two': [921], 'thirds': [922], 'analyzed),': [925], '11%': [926], 'died': [933], 'within': [934, 966, 1102], '7': [935, 1732, 1831, 2059, 2208], 'days': [936, 1104, 3455], 'transfusion': [938], 'compared': [939, 1042], '14%': [941], '(P': [946, 986], '=': [947, 987], '0.03)': [948], '(16).': [949], 'post': [952, 1086], 'hoc': [953, 1087], 'younger': [960], '80': [962], 'treated': [965], '72': [967], 'hours': [968], 'diagnosis,': [970], 'high-': [977], 'versus': [978], '6.3%': [982], '11.3%,': [984], 'respectively': [985], '0.0008)': [988], '(15).A': [989], 'similar': [990], '3082': [998], 'participants': [999, 1012], 'had': [1001, 1014], 'single': [1004, 1968], 'unit': [1005, 3447], '35': [1010], '322': [1011], 'through': [1017, 1292, 1579], '4': [1021], 'July': [1022], '2020': [1023, 2342, 2428, 3450, 3460, 3493, 3502], '(17).': [1024, 1295], 'Antibody': [1025], 'VITROS': [1032], 'anti–SARS-CoV-2': [1033], 'IgG': [1034], '(Ortho': [1036], 'Clinical': [1037, 2256, 3159, 3391], 'Diagnostics),': [1038], 'outcomes': [1040, 1179], 'receiving': [1045], 'low-': [1046], '(lowest': [1047], '18%),': [1048], 'medium-,': [1049], '(highest': [1052], '17%)': [1053], 'plasma.': [1054, 2053], 'After': [1055], 'adjusting': [1056], 'baseline': [1058], 'characteristics,': [1059], '30-day': [1061], 'rate': [1063], '29.1%': [1065], 'group': [1069], '24.7%': [1071], 'group.': [1075, 1171], 'did': [1078], 'reach': [1080], 'statistical': [1081], 'significance.': [1082], 'subgroup': [1088], 'also': [1090, 1432], 'suggested': [1091, 2430], 'benefit': [1093, 1189], '3': [1103], 'diagnosis': [1107], '(17).The': [1108], 'concluded': [1110], 'totality': [1113], 'additional': [1117, 1299], 'small': [1120], 'nonrandomized,': [1124], 'observational,': [1125], 'animal': [1127], 'studies,': [1128], 'met': [1129], 'issuance.Despite': [1134], 'clearly': [1135], 'meeting': [1136], 'effective”': [1140], 'criterion': [1141], 'issuance,': [1144], 'establish': [1155, 1421, 1660], 'because': [1163, 1476], 'untreated': [1169], 'control': [1170, 3176], 'For': [1172, 3050], 'example,': [1173], 'possibility': [1175], 'differences': [1177, 1209], 'attributable': [1181], 'harm': [1183], 'rather': [1187], 'cannot': [1193, 1373], 'excluded.': [1195], 'addition,': [1197, 1248], 'may': [1201, 1256, 1545], 'subject': [1203], 'confounders,': [1206], 'regional': [1208], 'temporal': [1211], 'trends': [1212, 3262], 'management.': [1215], 'There': [1216], 'widely': [1219], 'generally': [1222], 'agreed-upon': [1223], 'best': [1224, 1698, 2381], 'test': [1225], 'measuring': [1227], 'antibodies,': [1229], 'recovered': [1241], 'highly': [1245], 'variable.': [1246], 'focused': [1251], 'early': [1253], 'mortality,': [1254], 'clinically': [1259], 'meaningful': [1260], 'context': [1263], 'prolonged': [1266], 'course': [1268], 'COVID-19.': [1270, 2203], 'rely': [1274], 'thus': [1282], 'represent': [1283], 'fraction': [1286], 'regard,': [1298], 'cohort': [1304, 3090, 3204], 'completion': [1306], 'will': [1311, 2418], 'critical': [1314, 1472], 'importance.Taking': [1315], 'everything': [1316], 'into': [1317, 2258, 3174], 'account,': [1318], 'determined': [1322], 'currently': [1324], 'insufficient': [1328], 'recommend': [1330, 1374], 'against': [1333, 3110], '(18).': [1339], 'Prospective,': [1340], 'well-controlled,': [1341, 1611], 'adequately': [1343, 1612], 'needed': [1347, 1419, 1658, 1694], 'determine': [1349], 'whether': [1350, 1422], 'other': [1354, 1493], 'immunotherapies': [1356], 'effective': [1358, 1484], 'safe': [1360, 1426], 'treatment.': [1363], 'Although': [1364], 'therapy,': [1370], 'standard': [1378], 'time.': [1386], 'consistent': [1389], 'language': [1392], 'Fact': [1398, 2218], 'Sheet': [1399, 2219], '(19).The': [1400], 'intensified': [1404], 'rapid': [1409, 1673], 'generating': [1415], 'effective.': [1428], 'noted': [1433, 1468], 'West': [1436], 'African': [1437], 'outbreak': [1439], '2014': [1441], '2016,': [1443], 'therapies,': [1446], 'claimed': [1451], 'benefit.': [1455], 'A': [1456, 1847, 2334, 3136, 3169, 3202, 3378, 3435], 'Academies': [1458, 2249, 2265], 'Sciences,': [1460, 2251], 'Engineering,': [1461, 2252], 'review': [1464, 1899, 2363, 3138, 3275], 'response': [1467], 'outbreak,': [1475], 'they': [1477], 'quickest': [1480, 1685], 'way': [1481, 1689], 'identify': [1483], '(20).': [1486], 'Experience': [1487], 'hydroxychloroquine,': [1491], 'interventions': [1494], 'taught': [1496], 'us': [1497], 'large': [1499, 1534], 'observational': [1500], 'cohorts,': [1501], 'EAPs,': [1502], 'EUAs': [1504], 'can': [1505, 2599], 'profound': [1508], 'impact': [1509, 3077], 'our': [1511], 'ability': [1512, 1592], 'conduct': [1514], 'necessary': [1519], 'Conversely,': [1528], 'many': [1537], 'centers': [1540], 'exacerbate': [1546], 'issues': [1547], 'equity': [1549], 'care.': [1553], 'Programs': [1556], 'continue': [1557], 'important': [1561, 2803], 'mechanism': [1562], 'do': [1570], 'otherwise': [1572], 'them': [1576], '(that': [1577], 'is,': [1578], 'trials).': [1581], 'Balancing': [1582], 'challenging': [1586], 'but': [1587], 'imperative': [1588], 'maintaining': [1590], 'rigorous': [1595], 'convincing': [1597], 'crisis.Despite': [1603], 'challenges': [1605], 'conducting': [1610], 'possible.': [1616], 'Two': [1617], 'trials,': [1619], 'ACTT': [1620], '(Adaptive': [1621], 'Trial)': [1624], 'RECOVERY': [1626, 2305], '(Randomized': [1627], 'Evaluation': [1628, 1991], 'Therapy),': [1631], 'recently': [1632], 'remdesivir': [1637], 'dexamethasone,': [1639], 'respectively,': [1640], '(21,': [1644], '22).': [1645], 'Collaboration': [1646], 'partnership': [1648], 'governmental': [1650], 'agencies,': [1651], 'industry,': [1652], 'academia,': [1653], 'carry': [1662], 'out': [1663], 'robust': [1665], 'coordinated': [1667], 'research': [1669], 'response,': [1670], 'development,': [1674], 'deployment,': [1675], 'high-caliber': [1679], 'RCTs.': [1680], 'approach': [1682], 'most': [1687], 'efficient': [1688], 'answers': [1693], 'patient': [1700], 'care.Appendix': [1701], 'Table.': [1702, 3065], 'Members*References1.': [1711], 'Health.': [1715, 2046, 2184], 'Guidelines.': [1718], 'Appendix': [1719, 3064], 'A,': [1720], 'Table': [1721], '1.': [1722, 2098], 'Members.': [1727], 'Accessed': [1728, 1747, 1776, 1827, 2055, 2081, 2127, 2143, 2204, 2239], 'www.covid19treatmentguidelines.nih.gov/panel-roster': [1730], '2020.': [1734, 1753, 1782, 1833, 2061, 2087, 2133, 2149, 2175, 2210, 2245, 2321], 'Google': [1735, 1754, 1783, 1834, 2062, 2088, 2113, 2134, 2150, 2211, 2246, 2268], 'Scholar2.': [1736], 'Administration.': [1741, 1760, 2094, 2119, 2140, 2217], 'Convalescent': [1742, 1874, 2069, 2197, 2230, 2343, 3315, 3326, 3408], 'letter': [1744], 'authorization.': [1746], 'www.fda.gov/media/141477/download': [1749], '6': [1751, 2085, 2131, 2147, 2243], 'Scholar3.': [1755], 'Products': [1766], 'Related': [1768], 'Authorities:': [1769], 'Guidance': [1770], 'Industry': [1772], 'Other': [1774], 'Stakeholders.': [1775], 'www.fda.gov/media/97321/download': [1778], '31': [1780], 'Scholar4.': [1784], 'Fischer': [1785], 'JC,': [1786], 'Zänker': [1787], 'K,': [1788], 'van': [1789, 1979], 'Griensven': [1790, 1980], 'M,': [1791, 1869], 'et': [1792, 1842, 1872, 1918, 1953, 1987, 2158, 2303], 'al.': [1793, 1954, 2159], 'role': [1795, 2441], 'immunization': [1798], 'age': [1801], 'SARS-CoV-2:': [1803], 'update.': [1805], 'Eur': [1806], 'J': [1807, 1858, 1903, 2003, 2289, 2319], 'Med': [1808], 'Res.': [1809], '2020;25:16.': [1810], '[PMID:': [1811, 1861, 1907, 1942, 1974, 2006, 2039, 2176, 2292, 2322], '32404189]': [1812], 'doi:10.1186/s40001-020-00414-5': [1813], 'CrossrefMedlineGoogle': [1814, 1864, 1910, 1945, 1977, 2009, 2041, 2179, 2295, 2325], 'Scholar5.': [1815], 'Centers': [1816], 'Disease': [1818, 3129], 'Control': [1819], 'Prevention.': [1821], 'ACIP': [1822], 'Vaccine': [1823], 'Recommendations': [1824], 'Guidelienes.': [1826], 'www.cdc.gov/vaccines/hcp/acip-recs/index.html': [1829], 'Scholar6.': [1835], 'Mulangu': [1836], 'S,': [1837], 'Dodd': [1838, 2274], 'LE,': [1839], 'Davey': [1840], 'RT,': [1841], 'al;': [1843, 1873, 1919, 1988, 2304], 'PALM': [1844], 'Writing': [1845], 'Group.': [1846, 1877, 2307], 'randomized,': [1848], 'therapeutics.': [1855], 'N': [1856, 2001, 2287, 2317], 'Engl': [1857, 2002, 2288, 2318], 'Med.': [1859, 1940, 2004, 2290, 2320], '2019;381:2293-2303.': [1860], '31774950]': [1862], 'doi:10.1056/NEJMoa1910993': [1863], 'Scholar7.': [1865], 'Mair-Jenkins': [1866], 'J,': [1867, 1981], 'Saavedra-Campos': [1868], 'Baillie': [1870], 'JK,': [1871], 'Study': [1876, 1921], 'effectiveness': [1879], 'hyperimmune': [1884], 'etiology:': [1896], 'systematic': [1898, 3137], 'exploratory': [1901], 'meta-analysis.': [1902], 'Infect': [1904], 'Dis.': [1905], '2015;211:80-90.': [1906], '25030060]': [1908], 'doi:10.1093/infdis/jiu396': [1909], 'Scholar8.': [1911], 'Beigel': [1912, 2270], 'JH,': [1913, 1948, 2271], 'Tebas': [1914], 'P,': [1915, 2298], 'Elie-Turenne': [1916], 'MC,': [1917], 'IRC002': [1920], 'Team.': [1922], 'Immune': [1923], 'influenza:': [1930], 'open-label,': [1932], 'multicentre,': [1933], 'phase': [1934], 'randomised': [1936, 3279], 'study.': [1937], 'Lancet': [1938], 'Respir': [1939], '2017;5:500-511.': [1941], '28522352]': [1943], 'doi:10.1016/S2213-2600(17)30174-1': [1944], 'Scholar9.': [1946], 'Ko': [1947], 'Seok': [1949], 'H,': [1950], 'Cho': [1951], 'SY,': [1952], 'Challenges': [1955], 'infusion': [1959], 'therapy': [1960, 2401, 2432], 'infection:': [1966], 'centre': [1969], 'experience.': [1970, 2173], 'Antivir': [1971], 'Ther.': [1972], '2018;23:617-622.': [1973], '29923831]': [1975], 'doi:10.3851/IMP3243': [1976], 'Scholar10.': [1978], 'Edwards': [1982], 'T,': [1983], 'de': [1984, 2015], 'Lamballerie': [1985], 'X,': [1986], 'Ebola-Tx': [1989], 'Consortium.': [1990], 'Guinea.': [2000], '2016;374:33-42.': [2005], '26735992]': [2007], 'doi:10.1056/NEJMoa1511812': [2008], 'Scholar11.': [2010], 'Maiztegui': [2011], 'JI,': [2012], 'Fernandez': [2013, 3395], 'NJ,': [2014], 'Damilano': [2016], 'AJ.': [2017], 'Efficacy': [2018], 'immune': [2020, 3267], 'haemorrhagic': [2026], 'association': [2029], 'late': [2034], 'neurological': [2035], 'syndrome.': [2036], 'Lancet.': [2037], '1979;2:1216-7.': [2038], '92624]': [2040], 'Scholar12.': [2042], 'List': [2047], 'ClinicalTrials.gov.': [2054], 'www.clinicaltrials.gov/ct2/results?term=convalescent+plasma&cond=Covid19&intr=Randomized': [2057], 'Scholar13.': [2063], 'Clinic.': [2065], 'Accesss': [2067], 'Patients': [2075, 3363, 3389], 'With': [2076, 3329, 3350], '[Protocol].': [2078], 'Version': [2079], '10.0.': [2080], 'www.uscovidplasma.org/physicians-protocol': [2083], 'Scholar14.': [2089], 'Title': [2095], '21.': [2096], 'Chapter': [2097], 'Part': [2099], '312.': [2100], 'Subpart': [2101], 'I.': [2102], 'Drugs': [2107], 'Use.': [2110], 'Section': [2111], '312.305(a)(3).': [2112], 'Scholar15.': [2114], '26382:': [2121], 'Request.': [2126], 'www.fda.gov/media/141481/download': [2129], 'Scholar16.': [2135], 'U.S': [2136], 'Decisional': [2141], 'memo.': [2142], 'www.fda.gov/media/141480/download': [2145], 'Scholar17.': [2151], 'Joyner': [2152], 'MJ,': [2153], 'Senefeld': [2154], 'JW,': [2155], 'Klassen': [2156], 'SA,': [2157], 'Effect': [2160], 'initial': [2171], 'three-month': [2172], 'medRxiv.': [2174], '32817978]': [2177], 'doi:10.1101/2020.08.12.20169359': [2178], 'Scholar18.': [2180], "Panel's": [2189], 'Statement': [2190], 'www.covid19treatmentguidelines.nih.gov/statement-on-convalescent-plasma-eua': [2206], 'Scholar19.': [2212], 'Care': [2222, 3392], 'Providers.': [2223], 'Hospitalized': [2237], 'Patients.': [2238], 'www.fda.gov/media/141478/download': [2241], 'Scholar20.': [2247], 'Medicine.': [2254], 'Integrating': [2255], 'Research': [2257], 'Epidemic': [2259], 'Response:': [2260], 'Experience.': [2263], 'Pr;': [2266], '2017.': [2267], 'Scholar21.': [2269], 'Tomashek': [2272], 'KM,': [2273], 'LE.': [2275], 'Remdesivir': [2276], '-': [2282, 2314], 'preliminary': [2283, 2315], 'report.': [2284, 2316], 'Reply': [2285], '[Letter].': [2286], '2020;383:994.': [2291], '32649078]': [2293], 'doi:10.1056/NEJMc2022236': [2294], 'Scholar22.': [2296], 'Horby': [2297], 'Lim': [2299], 'WS,': [2300], 'Emberson': [2301], 'JR,': [2302], 'Collaborative': [2306], 'Dexamethasone': [2308], '32678530]': [2323], 'doi:10.1056/NEJMoa2021436': [2324], 'Scholar': [2326], 'Comments': [2327, 2329], '0': [2328], 'Sign': [2330], 'Submit': [2333], 'Comment': [2335], 'Daniel': [2336], 'ArkfeldKeck': [2337], 'Medicine27': [2340], 'Covid': [2346, 2434], '19-that': [2347], 'question.': [2350], 'It': [2351], 'great': [2354], 'interest': [2355], 'I': [2356, 2436], 'read': [2357], 'state': [2359], 'art': [2362], 'covid': [2368], '19.': [2369], 'Waiting': [2370], 'show': [2375], 'seems': [2377], 'practice.': [2382], 'saying': [2383], 'since': [2385], 'i': 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