PMC:7195088 / 14271-35170 JSONTXT 11 Projects

Annnotations TAB TSV DIC JSON TextAE

Id Subject Object Predicate Lexical cue
T88 0-175 Sentence denotes Table 2 Available and ongoing RCT on anti-infective and anti-inflammatory drugs most provided as off-label/compassionate treatments in the first phase of the COVID-19 pandemic
T89 176-327 Sentence denotes Drug Class/mechanism Published RCT Ongoing RCT for treatment/prevention of COVID-19 (recruiting or not yet recruiting) registered at ClinicalTrials.gov
T90 328-394 Sentence denotes Lopinavir/ritonavir Lopinavir is an HIV type 1 protease inhibitor.
T91 395-587 Sentence denotes Ritonavir is a CYP3A4 inhibitor that boosts lopinavir concentrations • Open-label RCT comparing lopinavir/ritonavir (99 patients) vs. standard of care (100) in patients with COVID-19 in China.
T92 588-665 Sentence denotes Lopinavir/ritonavir was administered at the dosage of 400/100 mg for 14 days.
T93 666-745 Sentence denotes The primary time-to-event endpoint was clinical improvement from randomization.
T94 746-1134 Sentence denotes In the primary study population (ITT), no statistically significant differences were observed with regard to the primary endpoint of clinical improvement (HR 1.24 with standard of care as reference, 95% CI 0.90 to 1.72) and the secondary endpoint of 28-day mortality (19.2% vs. 25.0% in investigational and comparator arms, respectively; percentage difference −5.8%, 95% CI −17.3 to 5.7).
T95 1135-1288 Sentence denotes In the mITT population, lopinavir/ritonavir led to a median time to clinical improvement that was shorter by 1 day than that observed with standard care.
T96 1289-1461 Sentence denotes Median time between symptoms onset and randomization was 13 days (IQR 11–16) [22] • Comparison of lopinavir/ritonavir vs. hydroxychloroquine in patients with mild COVID-19.
T97 1462-1503 Sentence denotes Open-label RCT (NCT04307693, recruiting).
T98 1504-1563 Sentence denotes Primary endpoint: virus load at day 3, 5, 7, 10, 14 and 18.
T99 1564-1667 Sentence denotes • Comparison of ASC09/ritonavir vs. lopinavir/ritonavir in patients with confirmed COVID-19 pneumoniae.
T100 1668-1717 Sentence denotes Open-label RCT (NCT04261907, not yet recruiting).
T101 1718-1887 Sentence denotes Primary endpoint: adverse outcome at day 14 (composite of Spo 2 ≤ 93% without oxygen supplementation, PaO2/FiO2 ≤ 300 mm Hg or respiratory rate ≥ 30 breaths per minute).
T102 1888-1990 Sentence denotes • Comparison of lopinavir/ritonavir vs. lopinavir/ritonavir plus umifenovir in patients with COVID-19.
T103 1991-2032 Sentence denotes Open-label RCT (NCT04252885, recruiting).
T104 2033-2109 Sentence denotes Primary endpoint: rate of virus inhibition at day 0, 2, 4, 7, 10, 14 and 21.
T105 2110-2235 Sentence denotes • Comparison of lopinavir/ritonavir vs. lopinavir/ritonavir plus ribavirin plus interferon beta 1b in patients with COVID-19.
T106 2236-2277 Sentence denotes Open-label RCT (NCT04276688, recruiting).
T107 2278-2360 Sentence denotes Primary endpoint: time to negative nasopharyngeal swab RT-PCR (follow-up 30 days).
T108 2361-2504 Sentence denotes • Comparison of only supportive treatment vs. lopinavir/ritonavir vs. oseltamivir vs. umifenovir in patients with confirmed COVID-19 pneumonia.
T109 2505-2546 Sentence denotes Open-label RCT (NCT04255017, recruiting).
T110 2547-2822 Sentence denotes Primary endpoints: (a) rate of disease remission (mild disease: fever, cough and other symptoms relieved with improved lung CT; severe disease: fever, cough and other symptoms relieved with improved lung CT, Spo 2 > 93% or Pao 2/Fio 2 > 300 mm Hg); (b) time to lung recovery.
T111 2823-2935 Sentence denotes • Comparison of chemoprophylaxis with lopinavir/ritonavir vs. placebo in healthcare workers exposed to COVID-19.
T112 2936-2987 Sentence denotes Double-blind RCT (NCT04328285, not yet recruiting).
T113 2988-3082 Sentence denotes Primary endpoint: occurrence of a symptomatic or asymptomatic COVID-19 (follow-up 2.5 months).
T114 3083-3199 Sentence denotes • Comparison of carrimycin vs. lopinavir/ritonavir or umifenovir or chloroquine in patients with COVID-19 pneumonia.
T115 3200-3249 Sentence denotes Open-label RCT (NCT04286503, not yet recruiting).
T116 3250-3432 Sentence denotes Primary endpoints: (a) fever to normal time (follow-up 30 days); (b) pulmonary inflammation resolution time (follow-up 30 days); (c) negative conversion of throat swab RT-PCR at EOT.
T117 3433-3615 Sentence denotes • Comparison of lopinavir/ritonavir vs. lopinavir/ritonavir plus xiyanping (injectable component derived from a plant used in traditional Chinese medicine) in patients with COVID-19.
T118 3616-3665 Sentence denotes Open-label RCT (NCT04295551, not yet recruiting).
T119 3666-3727 Sentence denotes Primary endpoint: clinical recovery time (follow-up 28 days).
T120 3728-3897 Sentence denotes • Comparison of lopinavir/ritonavir plus inhaled interferon alfa vs. lopinavir/ritonavir plus inhaled interferon alfa plus xiyanping injection in patients with COVID-19.
T121 3898-3947 Sentence denotes Open-label RCT (NCT04275388, not yet recruiting).
T122 3948-4009 Sentence denotes Primary endpoint: clinical recovery time (follow-up 14 days).
T123 4010-4189 Sentence denotes • Comparison of lopinavir/ritonavir plus inhaled interferon alfa vs. lopinavir/ritonavir plus inhaled interferon alfa plus traditional Chinese medicines in patients with COVID-19.
T124 4190-4231 Sentence denotes Open-label RCT (NCT04251871, recruiting).
T125 4232-4309 Sentence denotes Primary endpoint: time to complete remission of symptoms (follow-up 28 days).
T126 4310-4525 Sentence denotes • Comparison of lopinavir/ritonavir plus hydroxychloroquine vs. lopinavir/ritonavir plus hydroxychloroquine plus levamisole pill plus budesonide plus formoterol inhaler in patients with nonsevere COVID-19 pneumonia.
T127 4526-4579 Sentence denotes Partly blinded RCT (NCT04331470, not yet recruiting).
T128 4580-4661 Sentence denotes Primary endpoint: (a) clear CT scan at 3–7 days; (b) negative RT-PCR at 3–7 days.
T129 4662-4773 Sentence denotes • Comparison of lopinavir/ritonavir vs. hydroxychloroquine vs. losartan vs. placebos in patients with COVID-19.
T130 4774-4835 Sentence denotes Double-blind, adaptive RCT (NCT04328012, not yet recruiting).
T131 4836-4912 Sentence denotes Primary endpoint: NIAID COVID-19 ordinal severity scale (follow-up 60 days).
T132 4913-5082 Sentence denotes • Comparison of lopinavir/ritonavir vs. hydroxychloroquine vs. lopinavir/ritonavir plus interferon beta 1a vs. remdesivir vs. standard of care in patients with COVID-19.
T133 5083-5136 Sentence denotes Double-blind, adaptive RCT (NCT04315948, recruiting).
T134 5137-5208 Sentence denotes Primary endpoint: severity rating on a 7-point ordinal scale at day 15.
T135 5209-5508 Sentence denotes • Comparison of lopinavir/ritonavir or umifenovir or chloroquine or hydroxychloroquine or oseltamivir (with or without azithromycin) vs. natural honey plus lopinavir/ritonavir or umifenovir or chloroquine or hydroxychloroquine or oseltamivir (with or without azithromycin) in patients with COVID-19.
T136 5509-5560 Sentence denotes Single-blind RCT (NCT04323345, not yet recruiting).
T137 5561-5754 Sentence denotes Primary endpoints: (a) positive to negative swabs at day 14; (b) fever to normal temperature in days (follow-up 14 days); (c) resolution of lung inflammation in CT or X-ray (follow-up 30 days).
T138 5755-5892 Sentence denotes • Comparison of colchicine (with or without lopinavir/ritonavir) vs. local standard of care in patients with moderate to severe COVID-19.
T139 5893-5942 Sentence denotes Open-label RCT (NCT04328480, not yet recruiting).
T140 5943-6001 Sentence denotes Primary endpoint: all-cause mortality (follow-up 30 days).
T141 6002-6406 Sentence denotes • Comparison of oseltamivir plus chloroquine vs. oseltamivir plus lopinavir/ritonavir in patients with mild COVID-19 and of lopinavir/ritonavir plus oseltamivir vs. darunavir/ritonavir plus oseltamivir vs. favipiravir plus lopinavir/ritonavir vs. darunavir/ritonavir plus oseltamivir plus chloroquine vs. darunavir/ritonavir plus favipiravir plus oseltamivir in patients with moderate to severe COVID-19.
T142 6407-6456 Sentence denotes Open-label RCT (NCT04303299, not yet recruiting).
T143 6457-6524 Sentence denotes Primary endpoint: SARS-CoV-2 eradication time (follow-up 24 weeks).
T144 6525-6555 Sentence denotes Remdesivir Adenosine analogue.
T145 6556-6721 Sentence denotes It binds to RNA-dependent RNA polymerase and acts as an RNA-chain terminator • Not available • Comparison of remdesivir vs. placebo in patients with severe COVID-19.
T146 6722-6765 Sentence denotes Double-blind RCT (NCT04257656, recruiting).
T147 6766-6855 Sentence denotes Primary endpoint: clinical status, assessed by an ordinal scale at days 7, 14, 21 and 28.
T148 6856-6938 Sentence denotes • Comparison of remdesivir vs. placebo in patients with mild to moderate COVID-19.
T149 6939-6982 Sentence denotes Double-blind RCT (NCT04252664, recruiting).
T150 6983-7056 Sentence denotes Primary endpoint: time to clinical recovery in hours (follow-up 28 days).
T151 7057-7144 Sentence denotes • Comparison of remdesivir vs. local standard of care in patients with severe COVID-19.
T152 7145-7186 Sentence denotes Open-label RCT (NCT04252664, recruiting).
T153 7187-7294 Sentence denotes Primary endpoint: composite of fever normalization and oxygen saturation normalization (follow-up 14 days).
T154 7295-7384 Sentence denotes • Comparison of remdesivir vs. local standard of care in patients with moderate COVID-19.
T155 7385-7426 Sentence denotes Open-label RCT (NCT04292730, recruiting).
T156 7427-7473 Sentence denotes Primary endpoint: discharged status at day 14.
T157 7474-7539 Sentence denotes • Comparison of remdesivir vs. placebo in patients with COVID-19.
T158 7540-7583 Sentence denotes Double-blind RCT (NCT04280705, recruiting).
T159 7584-7655 Sentence denotes Primary endpoint: severity rating on a 8-point ordinal scale at day 15.
T160 7656-7771 Sentence denotes • Comparison of remdesivir vs. hydroxychloroquine vs. remdesivir plus hydroxychloroquine in patients with COVID-19.
T161 7772-7830 Sentence denotes Open-label adaptive RCT (NCT04321616, not yet recruiting).
T162 7831-7901 Sentence denotes Primary endpoint: all-cause in-hospital mortality (follow-up 3 weeks).
T163 7902-8071 Sentence denotes • Comparison of lopinavir/ritonavir vs. hydroxychloroquine vs. lopinavir/ritonavir plus interferon beta 1a vs. remdesivir vs. standard of care in patients with COVID-19.
T164 8072-8125 Sentence denotes Double-blind, adaptive RCT (NCT04315948, recruiting).
T165 8126-8197 Sentence denotes Primary endpoint: severity rating on a 7-point ordinal scale at day 15.
T166 8198-8265 Sentence denotes Darunavir/cobicistat Darunavir is an HIV type 1 protease inhibitor.
T167 8266-8446 Sentence denotes Cobicistat is a CYP3A4 inhibitor that boosts darunavir concentrations • Not available • Comparison of darunavir/cobicistat vs. standard of care in patients with COVID-19 pneumonia.
T168 8447-8488 Sentence denotes Open-label RCT (NCT04252274, recruiting).
T169 8489-8603 Sentence denotes Primary endpoint: virologic clearance rate of throat swabs, sputum or lower respiratory tract secretions at day 7.
T170 8604-8910 Sentence denotes Favipiravir Anti-influenza RNA-dependent RNA polymerase inhibitor • In a recent RCT published on a preprint server and comparing 120 COVID-19 patients treated with favipiravir vs. 120 COVID-19 patients receiving umifenovir, higher rates of clinical recovery were observed in patients receiving favipiravir.
T171 8911-9086 Sentence denotes The manuscript is publicly available but still to be peer reviewed [30] • Comparison of favipiravir vs. tocilizumab vs. favipiravir plus tocilizumab in patients with COVID-19.
T172 9087-9128 Sentence denotes Open-label RCT (NCT04310228, recruiting).
T173 9129-9182 Sentence denotes Primary endpoint: clinical cure (follow-up 3 months).
T174 9183-9587 Sentence denotes • Comparison of oseltamivir plus chloroquine vs. oseltamivir plus lopinavir/ritonavir in patients with mild COVID-19 and of lopinavir/ritonavir plus oseltamivir vs. darunavir/ritonavir plus oseltamivir vs. favipiravir plus lopinavir/ritonavir vs. darunavir/ritonavir plus oseltamivir plus chloroquine vs. darunavir/ritonavir plus favipiravir plus oseltamivir in patients with moderate to severe COVID-19.
T175 9588-9637 Sentence denotes Open-label RCT (NCT04303299, not yet recruiting).
T176 9638-9705 Sentence denotes Primary endpoint: SARS-CoV-2 eradication time (follow-up 24 weeks).
T177 9706-9814 Sentence denotes • Comparison of hydroxychloroquine plus darunavir/cobicistat vs. standard of care in patients with COVID-19.
T178 9815-9856 Sentence denotes Open-label RCT (NCT04304053, recruiting).
T179 9857-9974 Sentence denotes Primary endpoint: incidence of secondary cases among contacts of a case and contacts of contacts (follow-up 14 days).
T180 9975-10074 Sentence denotes • Comparison of chloroquine plus favipiravir vs. favipiravir vs. placebo in patients with COVID-19.
T181 10075-10118 Sentence denotes Double-blind RCT (NCT04319900, recruiting).
T182 10119-10290 Sentence denotes Primary endpoints: (a) time to improvement/recovery and frequency of improvement/recovery (follow-up 10 days); (b) time to negative swab/sputum RT-PCR (follow-up 10 days).
T183 10291-10366 Sentence denotes • Comparison of favipiravir vs. standard of care in patients with COVID-19.
T184 10367-10416 Sentence denotes Open-label RCT (NCT04333589, not yet recruiting).
T185 10417-10529 Sentence denotes Primary endpoint: viral nucleic acid test negative conversion rate in nasopharyngeal swabs (follow-up 5 months).
T186 10530-10934 Sentence denotes • Comparison of oseltamivir plus chloroquine vs. oseltamivir plus lopinavir/ritonavir in patients with mild COVID-19 and of lopinavir/ritonavir plus oseltamivir vs. darunavir/ritonavir plus oseltamivir vs. favipiravir plus lopinavir/ritonavir vs. darunavir/ritonavir plus oseltamivir plus chloroquine vs. darunavir/ritonavir plus favipiravir plus oseltamivir in patients with moderate to severe COVID-19.
T187 10935-10984 Sentence denotes Open-label RCT (NCT04303299, not yet recruiting).
T188 10985-11052 Sentence denotes Primary endpoint: SARS-CoV-2 eradication time (follow-up 24 weeks).
T189 11053-11345 Sentence denotes Umifenovir Anti-influenza membrane fusion inhibitor • In a recent RCT published on a preprint server and comparing 120 COVID-19 patients treated with favipiravir vs. 120 COVID-19 patients receiving umifenovir, higher rates of clinical recovery were observed in patients receiving favipiravir.
T190 11346-11502 Sentence denotes The manuscript is publicly available but still to be peer reviewed [30] • Comparison of umifenovir vs. standard of care in patients with COVID-19 pneumonia.
T191 11503-11552 Sentence denotes Open-label RCT (NCT04260594, not yet recruiting).
T192 11553-11621 Sentence denotes Primary endpoint: virus negative conversion rate (follow-up 7 days).
T193 11622-12001 Sentence denotes Chloroquine, hydroxychloroquine Some proposed mechanisms are the following: increase in the endosomal Ph necessary for the virus/host cell fusion; interference with the glycosylation of cell receptors; immunomodulatory activity • Not available • Comparison of different hydroxychloroquine dosages vs. placebo in three cohorts (outpatients, inpatients, healthcare workers a risk).
T194 12002-12126 Sentence denotes Double-blind RCT for outpatients and healthcare workers and open-label RCT for inpatients (NCT04329923, not yet recruiting).
T195 12127-12324 Sentence denotes Primary endpoints: (a) release from quarantine (outpatients, follow-up 14 days); (b) discharge (inpatients, follow-up 14 days); (c) development of COVID-19 (healthcare workers, follow-up 2 months).
T196 12325-12411 Sentence denotes • Comparison of hydroxychloroquine vs. ascorbic acid in contacts of COVID-19 patients.
T197 12412-12463 Sentence denotes Double-blind RCT (NCT04328961, not yet recruiting).
T198 12464-12532 Sentence denotes Primary endpoint: laboratory-confirmed COVID-19 (follow-up 14 days).
T199 12533-12669 Sentence denotes • Comparison of tocilizumab plus hydroxychloroquine plus azithromycin vs. tocilizumab plus hydroxychloroquine in patients with COVID-19.
T200 12670-12719 Sentence denotes Open-label RCT (NCT04332094, not yet recruiting).
T201 12720-12947 Sentence denotes Primary endpoints: (a) in-hospital mortality (follow-up 2 weeks); (b) need for mechanical ventilation in the ICU (follow-up 2 weeks).• Comparison of ciclesonide plus hydroxychloroquine vs. ciclesonide in patients with COVID-19.
T202 12948-12997 Sentence denotes Open-label RCT (NCT04330586, not yet recruiting).
T203 12998-13071 Sentence denotes Primary endpoint: SARS-CoV-2 eradication (based on virus load) at day 14.
T204 13072-13198 Sentence denotes • Comparison of hydroxychloroquine vs. placebo in patients with COVID-19 and under biological treatment and/or JAK inhibitors.
T205 13199-13250 Sentence denotes Double-blind RCT (NCT04330495, not yet recruiting).
T206 13251-13461 Sentence denotes Primary endpoints: (a) incidence rate of COVID-19 (follow-up 27 weeks); (b) prevalence of COVID-19 (follow-up 27 weeks); (c) case fatality rate (follow-up 27 weeks); (d) ICU admission rate (follow-up 27 weeks).
T207 13462-13570 Sentence denotes • Comparison of hydroxychloroquine vs. placebo for the prevention of COVID-19 in healthcare workers at risk.
T208 13571-13622 Sentence denotes Double-blind RCT (NCT04328467, not yet recruiting).
T209 13623-13685 Sentence denotes Primary endpoint: prevalence of COVID-19 (follow-up 12 weeks).
T210 13686-13798 Sentence denotes • Comparison of chemoprophylaxis with lopinavir/ritonavir vs. placebo in healthcare workers exposed to COVID-19.
T211 13799-13850 Sentence denotes Double-blind RCT (NCT04328285, not yet recruiting).
T212 13851-13868 Sentence denotes Primary endpoint:
T213 13869-13957 Sentence denotes Occurrence of a symptomatic or asymptomatic SARS-CoV-2 infection (follow-up 2.5 months).
T214 13958-14079 Sentence denotes • Comparison of hydroxychloroquine vs. placebo in symptomatic COVID-19 patients or exposed healthcare workers/households.
T215 14080-14123 Sentence denotes Double-blind RCT (NCT04308668, recruiting).
T216 14124-14271 Sentence denotes Primary endpoints: (a) incidence of symptomatic COVID-19 among asymptomatic participants; (b) severity rating on a 3-point ordinal scale at day 14.
T217 14272-14387 Sentence denotes • Comparison of remdesivir vs. hydroxychloroquine vs. remdesivir plus hydroxychloroquine in patients with COVID-19.
T218 14388-14446 Sentence denotes Open-label adaptive RCT (NCT04321616, not yet recruiting).
T219 14447-14517 Sentence denotes Primary endpoint: all-cause in-hospital mortality (follow-up 3 weeks).
T220 14518-14629 Sentence denotes • Comparison of lopinavir/ritonavir vs. hydroxychloroquine vs. losartan vs. placebos in patients with COVID-19.
T221 14630-14691 Sentence denotes Double-blind, adaptive RCT (NCT04328012, not yet recruiting).
T222 14692-14768 Sentence denotes Primary endpoint: NIAID COVID-19 Ordinal Severity Scale (follow-up 60 days).
T223 14769-14927 Sentence denotes • Comparison of convalescent plasma plus hydroxychloroquine plus azithromycin vs. hydroxychloroquine plus azithromycin in hospitalized patients with COVID-19.
T224 14928-14977 Sentence denotes Open-label RCT (NCT04332835, not yet recruiting).
T225 14978-15157 Sentence denotes Primary endpoints: (a) change in virus load at days 0, 4, 7, 14 and 28; (b) change in IgM COVID-19 titers at days 0, 4, 7, 14 and 28; (c) change in IgG at days 0, 4, 7, 14 and 28.
T226 15158-15327 Sentence denotes • Comparison of lopinavir/ritonavir vs. hydroxychloroquine vs. lopinavir/ritonavir plus interferon beta-1a vs. remdesivir vs. standard of care in patients with COVID-19.
T227 15328-15381 Sentence denotes Double-blind, adaptive RCT (NCT04315948, recruiting).
T228 15382-15453 Sentence denotes Primary endpoint: severity rating on a 7-point ordinal scale at day 15.
T229 15454-15816 Sentence denotes Methylprednisolone A subgroup of patients with severe COVID-19 might develop a cytokine storm syndrome which causes rapidly progressive pneumonia, ARDS and clinical deterioration and corticosteroids administration may halt the dysregulated cytokine release • Not available • Comparison of methylprednisolone vs. standard of care in patients with severe COVID-19.
T230 15817-15858 Sentence denotes Open-label RCT (NCT04244591, recruiting).
T231 15859-15925 Sentence denotes Primary endpoint: lower Murray lung injury score at days 7 and 14.
T232 15926-16008 Sentence denotes • Comparison of methylprednisolone vs. standard of care in patients with COVID-19.
T233 16009-16050 Sentence denotes Open-label RCT (NCT04273321, recruiting).
T234 16051-16107 Sentence denotes Primary endpoint: treatment failure (follow-up 14 days).
T235 16108-16308 Sentence denotes • Comparison of inhaled alpha interferon plus methylprednisolone plus umifenovir vs. thalidomide plus inhaled alpha interferon plus methylprednisolone plus umifenovir in patients with severe COVID-19.
T236 16309-16360 Sentence denotes Double-blind RCT (NCT04273581, not yet recruiting).
T237 16361-16428 Sentence denotes Primary endpoint: time to clinical improvement (follow-up 28 days).
T238 16429-16511 Sentence denotes • Comparison of different dosages of methylprednisolone in patients with COVID-19.
T239 16512-16553 Sentence denotes Open-label RCT (NCT04263402, recruiting).
T240 16554-16635 Sentence denotes Primary endpoints: (a) disease readmission at day 7; (b) critical stage at day 7.
T241 16636-16744 Sentence denotes • Comparison of siltuximab (anti–IL-6 monoclonal antibody) vs. methylprednisolone in patients with COVID-19.
T242 16745-16794 Sentence denotes Open-label RCT (NCT04329650, not yet recruiting).
T243 16795-16846 Sentence denotes Primary endpoint: ICU admission (follow-up 29 days)
T244 16847-16963 Sentence denotes Tocilizumab Humanized monoclonal IgG1 antibody, tocilizumab inhibits both membrane-bound and soluble IL-6 receptors.
T245 16964-17214 Sentence denotes IL-6, is one of the main drivers of immunologic response and symptoms in patients with dysregulated cytokine release that has been observed in severe COVID-19 • Not available • Comparison of tocilizumab vs. standard of care in patients with COVID-19.
T246 17215-17264 Sentence denotes Open-label RCT (NCT04331808, not yet recruiting).
T247 17265-17367 Sentence denotes Primary endpoint: WHO progression scale at day 7 and 14 (severity rating on a 10-point ordinal scale).
T248 17368-17471 Sentence denotes • Comparison of favipiravir vs. tocilizumab vs. favipiravir plus tocilizumab in patients with COVID-19.
T249 17472-17513 Sentence denotes Open-label RCT (NCT04310228, recruiting).
T250 17514-17567 Sentence denotes Primary endpoint: clinical cure (follow-up 3 months).
T251 17568-17647 Sentence denotes • Comparison of tocilizumab vs. placebo in hospitalized patients with COVID-19.
T252 17648-17699 Sentence denotes Double-blind RCT (NCT04320615, not yet recruiting).
T253 17700-17771 Sentence denotes Primary endpoint: severity rating on a 7-point ordinal scale at day 28.
T254 17772-17908 Sentence denotes • Comparison of tocilizumab plus hydroxychloroquine plus azithromycin vs. tocilizumab plus hydroxychloroquine in patients with COVID-19.
T255 17909-17958 Sentence denotes Open-label RCT (NCT04332094, not yet recruiting).
T256 17959-18092 Sentence denotes Primary endpoints: (a) in-hospital mortality (follow-up 2 weeks); (b) need for mechanical ventilation in the ICU (follow-up 2 weeks).
T257 18093-18248 Sentence denotes • Comparison of chloroquine analog (GNS651) vs. tocilizumab vs. nivolumab vs. standard of care in patients with advanced or metastatic cancer and COVID-19.
T258 18249-18298 Sentence denotes Open-label RCT (NCT04333914, not yet recruiting).
T259 18299-18316 Sentence denotes Primary endpoint:
T260 18317-18333 Sentence denotes 28-day survival.
T261 18334-18535 Sentence denotes • Comparison of tocilizumab intravenously vs. tocilizumab subcutaneously vs. sarilumab (anti-interleukin 6 receptor α monoclonal antibody) subcutaneously vs. standard of care in patients with COVID-19.
T262 18536-18585 Sentence denotes Open-label RCT (NCT04322773, not yet recruiting).
T263 18586-18679 Sentence denotes Primary endpoint: time to independence from supplementary oxygen therapy (follow-up 28 days).
T264 18680-18881 Sentence denotes • Comparison of tocilizumab vs. anakinra (recombinant IL-1 receptor antagonist) vs. siltuximab vs. anakinra plus siltuximab vs. anakinra plus tocilizumab vs. standard of care in patients with COVID-19.
T265 18882-18931 Sentence denotes Open-label RCT (NCT04330638, not yet recruiting).
T266 18932-18999 Sentence denotes Primary endpoint: time to clinical improvement (follow-up 15 days).
T267 19000-19116 Sentence denotes • Comparison of carrimycin vs. lopinavir/ritonavir or umifenovir or chloroquine in patients with COVID-19 pneumonia.
T268 19117-19166 Sentence denotes Open-label RCT (NCT04286503, not yet recruiting).
T269 19167-19349 Sentence denotes Primary endpoints: (a) fever to normal time (follow-up 30 days); (b) pulmonary inflammation resolution time (follow-up 30 days); (c) negative conversion of throat swab RT-PCR at EOT.
T270 19350-19387 Sentence denotes Anakinra Antagonist of IL-1 receptor.
T271 19388-19644 Sentence denotes IL-1 is one of the main drivers of immunologic response and symptoms in patients with cytokine-release syndrome. • Not available • Comparison of anakinra vs. emapalumab (anti–interferon γ monoclonal antibody) vs. standard of care in patients with COVID-19.
T272 19645-19694 Sentence denotes Open-label RCT (NCT04324021, not yet recruiting).
T273 19695-19741 Sentence denotes Primary endpoint: treatment success at day 15.
T274 19742-19943 Sentence denotes • Comparison of tocilizumab vs. anakinra (recombinant IL-1 receptor antagonist) vs. siltuximab vs. anakinra plus siltuximab vs. anakinra plus tocilizumab vs. standard of care in patients with COVID-19.
T275 19944-19993 Sentence denotes Open-label RCT (NCT04330638, not yet recruiting).
T276 19994-20061 Sentence denotes Primary endpoint: time to clinical improvement (follow-up 15 days).
T277 20062-20195 Sentence denotes Off-label drugs mostly provided in Italy during the first phase of the COVID-19 pandemic according to the authors' direct experience.
T278 20196-20379 Sentence denotes Of note, there are also registered RCT for other drugs to be investigated in patients with COVID-19 (e.g. the Janus kinase family inhibitors ruxolitinib, baricitinib and tofacitinib).
T279 20380-20899 Sentence denotes ARDS = acute respiratory distress syndrome; CI, confidence interval; COVID-19, coronavirus disease 2019; CT, computed tomography; EOT, end of treatment; HR, hazard ratio; Ig, immunoglobulin; IL-1, interleukin 1; IQR, interquartile range; ITT, intent to treat; mITT, modified intent to treat; Pao2/Fio2, of arterial oxygen partial pressure to fractional inspired oxygen; RCT, randomized controlled trial; RT-PCR, real-time PCR; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; WHO, World Health Organization.