FRAGILE-COLCOVID19: A Clinical Trial Based on Early Administration of an Oral Combination of Colchicine and Prednisone in Elderly Patients with COVID-19 in Geriatric Facilities
Background Unprotected and fragile elderly people in nursing homes experienced the highest mortality rates during the initial coronavirus disease 2019 (COVID-19) pandemic. Objective Our aim was to study the role of two oral anti-inflammatory drugs, colchicine and prednisone, in elderly patients with COVID-19 in geriatric centers. Methods A phase II/III, randomized, controlled, multicenter clinical trial was performed in a geriatric population comparing the efficacy and safety of an oral combination of prednisone (60 mg/day for 3 days) and colchicine (at loading doses of 1–1.5 mg/day for 3 days, followed by 0.5 mg/day for 11 days) with the standard treatment, based on intravenous dexamethasone. Primary endpoints assessed the efficacy in reducing death or the modified endpoint death/therapeutic failure to the study drugs over a 28-day period, while secondary endpoints included safety, laboratory changes, and additional therapies used. Results Fifty-four patients (35 female/19 male) were enrolled, 25 (46.3%) of whom were allocated to the experimental arm and 29 (53.7%) to the control arm. At day 28, no differences in deaths were observed. The combination of mortality or therapeutic failure occurred in 12 (45.13%) patients receiving dexamethasone and 6 (28.13%) patients receiving colchicine/prednisone, resulting in a reduction of risk difference (RD) of − 17% (p = 0.17), with an average reduction of 39% (risk ratio [RR] 0.61) in patients receiving colchicine/prednisone (p = 0.25). Control patients received higher amounts of additional glucocorticoids (p = 0.0095) over a longer time frame (p = 0.0003). Colchicine/prednisone significantly reduced ferritin levels at day 14, as well as d-dimer and lactate dehydrogenase (LDH) levels at day 28. Adverse events were similar in both groups. Conclusions The combination colchicine/prednisone compared with intravenous dexamethasone has shown a remarkable trend to increase disease survival over a 28-day period in elderly patients requiring oxygen therapy in geriatric centers, without safety issues. Clinical Trial Registry Clinical Trials Registration Number: NCT04492358..
Medienart: |
Artikel |
---|
Erscheinungsjahr: |
2022 |
---|---|
Erschienen: |
2022 |
Enthalten in: |
Zur Gesamtaufnahme - volume:42 |
---|---|
Enthalten in: |
Clinical drug investigation - 42(2022), 11 vom: 29. Sept., Seite 949-964 |
Sprache: |
Englisch |
---|
Beteiligte Personen: |
Hernández-Rodríguez, José [VerfasserIn] |
---|
Links: |
Volltext [lizenzpflichtig] |
---|
Anmerkungen: |
© The Author(s) 2022 |
---|
doi: |
10.1007/s40261-022-01201-2 |
---|
funding: |
|
---|---|
Förderinstitution / Projekttitel: |
|
PPN (Katalog-ID): |
OLC2079873032 |
---|
LEADER | 01000caa a22002652 4500 | ||
---|---|---|---|
001 | OLC2079873032 | ||
003 | DE-627 | ||
005 | 20230516085705.0 | ||
007 | tu | ||
008 | 230131s2022 xx ||||| 00| ||eng c | ||
024 | 7 | |a 10.1007/s40261-022-01201-2 |2 doi | |
035 | |a (DE-627)OLC2079873032 | ||
035 | |a (DE-He213)s40261-022-01201-2-p | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
082 | 0 | 4 | |a 610 |q VZ |
084 | |a 15,3 |2 ssgn | ||
084 | |a PHARM |q DE-84 |2 fid | ||
100 | 1 | |a Hernández-Rodríguez, José |e verfasserin |0 (orcid)0000-0002-2357-2015 |4 aut | |
245 | 1 | 0 | |a FRAGILE-COLCOVID19: A Clinical Trial Based on Early Administration of an Oral Combination of Colchicine and Prednisone in Elderly Patients with COVID-19 in Geriatric Facilities |
264 | 1 | |c 2022 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a ohne Hilfsmittel zu benutzen |b n |2 rdamedia | ||
338 | |a Band |b nc |2 rdacarrier | ||
500 | |a © The Author(s) 2022 | ||
520 | |a Background Unprotected and fragile elderly people in nursing homes experienced the highest mortality rates during the initial coronavirus disease 2019 (COVID-19) pandemic. Objective Our aim was to study the role of two oral anti-inflammatory drugs, colchicine and prednisone, in elderly patients with COVID-19 in geriatric centers. Methods A phase II/III, randomized, controlled, multicenter clinical trial was performed in a geriatric population comparing the efficacy and safety of an oral combination of prednisone (60 mg/day for 3 days) and colchicine (at loading doses of 1–1.5 mg/day for 3 days, followed by 0.5 mg/day for 11 days) with the standard treatment, based on intravenous dexamethasone. Primary endpoints assessed the efficacy in reducing death or the modified endpoint death/therapeutic failure to the study drugs over a 28-day period, while secondary endpoints included safety, laboratory changes, and additional therapies used. Results Fifty-four patients (35 female/19 male) were enrolled, 25 (46.3%) of whom were allocated to the experimental arm and 29 (53.7%) to the control arm. At day 28, no differences in deaths were observed. The combination of mortality or therapeutic failure occurred in 12 (45.13%) patients receiving dexamethasone and 6 (28.13%) patients receiving colchicine/prednisone, resulting in a reduction of risk difference (RD) of − 17% (p = 0.17), with an average reduction of 39% (risk ratio [RR] 0.61) in patients receiving colchicine/prednisone (p = 0.25). Control patients received higher amounts of additional glucocorticoids (p = 0.0095) over a longer time frame (p = 0.0003). Colchicine/prednisone significantly reduced ferritin levels at day 14, as well as d-dimer and lactate dehydrogenase (LDH) levels at day 28. Adverse events were similar in both groups. Conclusions The combination colchicine/prednisone compared with intravenous dexamethasone has shown a remarkable trend to increase disease survival over a 28-day period in elderly patients requiring oxygen therapy in geriatric centers, without safety issues. Clinical Trial Registry Clinical Trials Registration Number: NCT04492358. | ||
700 | 1 | |a Durán-Sanclemente, Julio |4 aut | |
700 | 1 | |a Prieto-González, Sergio |0 (orcid)0000-0002-7242-5265 |4 aut | |
700 | 1 | |a Araújo, Olga |0 (orcid)0000-0003-1763-1880 |4 aut | |
700 | 1 | |a Hospital-Vidal, Teresa |4 aut | |
700 | 1 | |a Casanovas, Georgina |0 (orcid)0000-0003-1629-5475 |4 aut | |
700 | 1 | |a Sapena, Víctor |0 (orcid)0000-0003-4379-6486 |4 aut | |
700 | 1 | |a Blanco, José Luis |0 (orcid)0000-0003-2010-2744 |4 aut | |
700 | 1 | |a López-Soto, Alfonso |0 (orcid)0000-0003-4297-3217 |4 aut | |
773 | 0 | 8 | |i Enthalten in |t Clinical drug investigation |d Springer International Publishing, 1995 |g 42(2022), 11 vom: 29. Sept., Seite 949-964 |w (DE-627)18259954X |w (DE-600)1220136-4 |w (DE-576)045294798 |x 1173-2563 |7 nnns |
773 | 1 | 8 | |g volume:42 |g year:2022 |g number:11 |g day:29 |g month:09 |g pages:949-964 |
856 | 4 | 1 | |u https://doi.org/10.1007/s40261-022-01201-2 |z lizenzpflichtig |3 Volltext |
912 | |a GBV_USEFLAG_A | ||
912 | |a SYSFLAG_A | ||
912 | |a GBV_OLC | ||
912 | |a FID-PHARM | ||
912 | |a SSG-OLC-PHA | ||
912 | |a SSG-OLC-DE-84 | ||
912 | |a SSG-OPC-PHA | ||
951 | |a AR | ||
952 | |d 42 |j 2022 |e 11 |b 29 |c 09 |h 949-964 |