Efficacy and Outcome of Remdesivir and Tocilizumab Combination Against Dexamethasone for the Treatment of Severe COVID-19 : A Randomized Controlled Trial
Copyright © 2022 Mohiuddin Chowdhury, Kamal, Abbas, Talukder, Karim, Ali, Nuruzzaman, Li and He..
Objective: In this study, we investigated the efficacy and safety of remdesivir and tocilizumab combination therapy against dexamethasone for the management of severe COVID-19 patients. Methods: This was a multicenter study. Cases were randomly chosen and divided into two groups using an odd-even ratio of 1:1 applied to the hospital registration number. Group A received remdesivir [5 mg/kg (<40 kg) or 200 mg (>40 kg) on day 1 and then 2.5 mg/kg (<40 kg) or 100 mg (>40 kg) daily] + tocilizumab [8 mg/kg up to 800 mg highest 12 h apart], and group B was the control and received dexamethasone 6 mg/day. In addition, a broad-spectrum antibiotic and other essential treatments were received by all patients. To evaluate the mortality risk, the sequential organ failure assessment (SOFA) score was calculated on day-1. Treatment outcomes were measured as time to clinical improvement; mortality rate; duration of ICU stay; total period of hospitalization; the rate of (Supplementary Material) oxygen use; time to clinical failure; National Early Warning Score-2 (NEWS), and the percentage of lung recovery on CT of chest on discharge. Clinical trial registration ID: NCT04678739. Results: Remdesivir-Tocilizumab group had a lower mortality rate (25.49%) than the control (30.77%). The time to clinical improvement (Group A-9.41; B-14.21 days), NEWS-2 on discharge (Group A-0.89; B-1.2), duration of ICU stay (Group A-7.68; B-10.58), and duration of hospitalization (Group A-9.91; B-14.68) were less in the treatment group. Group A had a better percentage of lung recovery on chest CT than the control (Group A-22.13; B-11.74). All these differences were statistically significant (p= <0.05) in a t-test. However, no significant survival benefit was found among the study groups in Kaplan-Meier survival analysis, p = 0.739. Conclusion: The remdesivir-tocilizumab combination had preferable outcomes compared to the dexamethasone therapy for the treatment of severe COVID-19 concerning mortality rate and clinical and pulmonary improvement, although it did not demonstrate a significant survival benefit. Clinical Trial Registration: https://clinicaltrials.gov, NCT04678739.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2022 |
|---|---|
| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
|---|---|
| Enthalten in: |
Frontiers in pharmacology - 13(2022) vom: 13., Seite 690726 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Mohiuddin Chowdhury, Abu Taiub Mohammed [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Bangladesh |
|---|
| Anmerkungen: |
Date Revised 16.07.2022 published: Electronic-eCollection ClinicalTrials.gov: NCT04678739 Citation Status PubMed-not-MEDLINE |
|---|
| doi: |
10.3389/fphar.2022.690726 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM339792663 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM339792663 | ||
| 003 | DE-627 | ||
| 005 | 20231226003703.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2022 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.3389/fphar.2022.690726 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1132.xml |
| 035 | |a (DE-627)NLM339792663 | ||
| 035 | |a (NLM)35450050 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Mohiuddin Chowdhury, Abu Taiub Mohammed |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy and Outcome of Remdesivir and Tocilizumab Combination Against Dexamethasone for the Treatment of Severe COVID-19 |b A Randomized Controlled Trial |
| 264 | 1 | |c 2022 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 16.07.2022 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a ClinicalTrials.gov: NCT04678739 | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a Copyright © 2022 Mohiuddin Chowdhury, Kamal, Abbas, Talukder, Karim, Ali, Nuruzzaman, Li and He. | ||
| 520 | |a Objective: In this study, we investigated the efficacy and safety of remdesivir and tocilizumab combination therapy against dexamethasone for the management of severe COVID-19 patients. Methods: This was a multicenter study. Cases were randomly chosen and divided into two groups using an odd-even ratio of 1:1 applied to the hospital registration number. Group A received remdesivir [5 mg/kg (<40 kg) or 200 mg (>40 kg) on day 1 and then 2.5 mg/kg (<40 kg) or 100 mg (>40 kg) daily] + tocilizumab [8 mg/kg up to 800 mg highest 12 h apart], and group B was the control and received dexamethasone 6 mg/day. In addition, a broad-spectrum antibiotic and other essential treatments were received by all patients. To evaluate the mortality risk, the sequential organ failure assessment (SOFA) score was calculated on day-1. Treatment outcomes were measured as time to clinical improvement; mortality rate; duration of ICU stay; total period of hospitalization; the rate of (Supplementary Material) oxygen use; time to clinical failure; National Early Warning Score-2 (NEWS), and the percentage of lung recovery on CT of chest on discharge. Clinical trial registration ID: NCT04678739. Results: Remdesivir-Tocilizumab group had a lower mortality rate (25.49%) than the control (30.77%). The time to clinical improvement (Group A-9.41; B-14.21 days), NEWS-2 on discharge (Group A-0.89; B-1.2), duration of ICU stay (Group A-7.68; B-10.58), and duration of hospitalization (Group A-9.91; B-14.68) were less in the treatment group. Group A had a better percentage of lung recovery on chest CT than the control (Group A-22.13; B-11.74). All these differences were statistically significant (p= <0.05) in a t-test. However, no significant survival benefit was found among the study groups in Kaplan-Meier survival analysis, p = 0.739. Conclusion: The remdesivir-tocilizumab combination had preferable outcomes compared to the dexamethasone therapy for the treatment of severe COVID-19 concerning mortality rate and clinical and pulmonary improvement, although it did not demonstrate a significant survival benefit. Clinical Trial Registration: https://clinicaltrials.gov, NCT04678739 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Bangladesh | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a COVID-19 ARDS | |
| 650 | 4 | |a SARS-Cov-2 | |
| 650 | 4 | |a dexamethasone | |
| 650 | 4 | |a remdecivir | |
| 650 | 4 | |a tocilizumab | |
| 700 | 1 | |a Kamal, Aktar |e verfasserin |4 aut | |
| 700 | 1 | |a Abbas, Kafil Uddin |e verfasserin |4 aut | |
| 700 | 1 | |a Talukder, Shubhashis |e verfasserin |4 aut | |
| 700 | 1 | |a Karim, Md Rezaul |e verfasserin |4 aut | |
| 700 | 1 | |a Ali, Md Ahsan |e verfasserin |4 aut | |
| 700 | 1 | |a Nuruzzaman, Md |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Yarui |e verfasserin |4 aut | |
| 700 | 1 | |a He, Shuixiang |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Frontiers in pharmacology |d 2010 |g 13(2022) vom: 13., Seite 690726 |w (DE-627)NLM208568891 |x 1663-9812 |7 nnns |
| 773 | 1 | 8 | |g volume:13 |g year:2022 |g day:13 |g pages:690726 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.3389/fphar.2022.690726 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 13 |j 2022 |b 13 |h 690726 | ||