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. |