Home > Research > Publications & Outputs > Evaluation of the efficacy and safety of intrav...

Links

Text available via DOI:

View graph of relations

Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19: Study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial

Research output: Contribution to journalJournal articlepeer-review

Published

Standard

Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19 : Study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial. / Wang, Y.; Zhou, F.; Zhang, D.; Zhao, J.; Du, R.; Hu, Y.; Cheng, Z.; Gao, L.; Jin, Y.; Luo, G.; Fu, S.; Lu, Q.; Du, G.; Wang, K.; Lu, Y.; Fan, G.; Zhang, Y.; Liu, Y.; Ruan, S.; Liu, W.; Jaki, T.; Hayden, F.G.; Horby, P.W.; Cao, B.; Wang, C.

In: Trials, Vol. 21, No. 1, 422, 24.05.2020.

Research output: Contribution to journalJournal articlepeer-review

Harvard

Wang, Y, Zhou, F, Zhang, D, Zhao, J, Du, R, Hu, Y, Cheng, Z, Gao, L, Jin, Y, Luo, G, Fu, S, Lu, Q, Du, G, Wang, K, Lu, Y, Fan, G, Zhang, Y, Liu, Y, Ruan, S, Liu, W, Jaki, T, Hayden, FG, Horby, PW, Cao, B & Wang, C 2020, 'Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19: Study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial', Trials, vol. 21, no. 1, 422. https://doi.org/10.1186/s13063-020-04352-9

APA

Wang, Y., Zhou, F., Zhang, D., Zhao, J., Du, R., Hu, Y., Cheng, Z., Gao, L., Jin, Y., Luo, G., Fu, S., Lu, Q., Du, G., Wang, K., Lu, Y., Fan, G., Zhang, Y., Liu, Y., Ruan, S., ... Wang, C. (2020). Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19: Study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial. Trials, 21(1), [422]. https://doi.org/10.1186/s13063-020-04352-9

Vancouver

Author

Wang, Y. ; Zhou, F. ; Zhang, D. ; Zhao, J. ; Du, R. ; Hu, Y. ; Cheng, Z. ; Gao, L. ; Jin, Y. ; Luo, G. ; Fu, S. ; Lu, Q. ; Du, G. ; Wang, K. ; Lu, Y. ; Fan, G. ; Zhang, Y. ; Liu, Y. ; Ruan, S. ; Liu, W. ; Jaki, T. ; Hayden, F.G. ; Horby, P.W. ; Cao, B. ; Wang, C. / Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19 : Study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial. In: Trials. 2020 ; Vol. 21, No. 1.

Bibtex

@article{430d28b298924f5c8e5ac70cb4af95d9,
title = "Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19: Study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial",
abstract = "Background: Coronavirus disease 2019 (COVID-19), caused by a novel corinavirus (later named SARS-CoV-2 virus), was fistly reported in Wuhan, Hubei Province, China towards the end of 2019. Large-scale spread within China and internationally led the World Health Organization to declare a Public Health Emergency of International Concern on 30th January 2020. The clinical manifestations of COVID-19 virus infection include asymptomatic infection, mild upper respiratory symptoms, severe viral pneumonia with respiratory failure, and even death. There are no antivirals of proven clinical efficacy in coronavirus infections. Remdesivir (GS-5734), a nucleoside analogue, has inhibitory effects on animal and human highly pathogenic coronaviruses, including MERS-CoV and SARS-CoV, in in vitro and in vivo experiments. It is also inhibitory against the COVID-19 virus in vitro. The aim of this study is to assess the efficacy and safety of remdesivir in adult patients with severe COVID-19. Methods: The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. This is a phase 3, randomized, double-blind, placebo-controlled, multicentre trial. Adults (≥ 18 years) with laboratory-confirmed COVID-19 virus infection, severe pneumonia signs or symptoms, and radiologically confirmed severe pneumonia are randomly assigned in a 2:1 ratio to intravenously administered remdesivir or placebo for 10 days. The primary endpoint is time to clinical improvement (censored at day 28), defined as the time (in days) from randomization of study treatment (remdesivir or placebo) until a decline of two categories on a six-category ordinal scale of clinical status (1 = discharged; 6 = death) or live discharge from hospital. One interim analysis for efficacy and futility will be conducted once half of the total number of events required has been observed. Discussion: This is the first randomized, placebo-controlled trial in COVID-19. Enrolment began in sites in Wuhan, Hubei Province, China on 6th February 2020. Trial registration: ClinicalTrials.gov: NCT04257656. Registered on 6 February 2020. {\textcopyright} 2020 The Author(s).",
keywords = "Administrative information, Antiviral, China, Clinical trial, COVID-19, Remdesivir, adenosine phosphate, alanine, antivirus agent, remdesivir, Betacoronavirus, Coronavirus infection, double blind procedure, drug effect, equivalence trial (topic), female, human, intravenous drug administration, male, multicenter study (topic), pandemic, pathogenicity, patient safety, phase 3 clinical trial (topic), risk assessment, risk factor, severity of illness index, time factor, treatment outcome, virology, virus pneumonia, Adenosine Monophosphate, Alanine, Antiviral Agents, Clinical Trials, Phase III as Topic, Coronavirus Infections, Double-Blind Method, Equivalence Trials as Topic, Female, Humans, Infusions, Intravenous, Male, Multicenter Studies as Topic, Pandemics, Patient Safety, Pneumonia, Viral, Risk Assessment, Risk Factors, Severity of Illness Index, Time Factors, Treatment Outcome",
author = "Y. Wang and F. Zhou and D. Zhang and J. Zhao and R. Du and Y. Hu and Z. Cheng and L. Gao and Y. Jin and G. Luo and S. Fu and Q. Lu and G. Du and K. Wang and Y. Lu and G. Fan and Y. Zhang and Y. Liu and S. Ruan and W. Liu and T. Jaki and F.G. Hayden and P.W. Horby and B. Cao and C. Wang",
year = "2020",
month = may,
day = "24",
doi = "10.1186/s13063-020-04352-9",
language = "English",
volume = "21",
journal = "Trials",
issn = "1745-6215",
publisher = "BIOMED CENTRAL LTD",
number = "1",

}

RIS

TY - JOUR

T1 - Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19

T2 - Study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial

AU - Wang, Y.

AU - Zhou, F.

AU - Zhang, D.

AU - Zhao, J.

AU - Du, R.

AU - Hu, Y.

AU - Cheng, Z.

AU - Gao, L.

AU - Jin, Y.

AU - Luo, G.

AU - Fu, S.

AU - Lu, Q.

AU - Du, G.

AU - Wang, K.

AU - Lu, Y.

AU - Fan, G.

AU - Zhang, Y.

AU - Liu, Y.

AU - Ruan, S.

AU - Liu, W.

AU - Jaki, T.

AU - Hayden, F.G.

AU - Horby, P.W.

AU - Cao, B.

AU - Wang, C.

PY - 2020/5/24

Y1 - 2020/5/24

N2 - Background: Coronavirus disease 2019 (COVID-19), caused by a novel corinavirus (later named SARS-CoV-2 virus), was fistly reported in Wuhan, Hubei Province, China towards the end of 2019. Large-scale spread within China and internationally led the World Health Organization to declare a Public Health Emergency of International Concern on 30th January 2020. The clinical manifestations of COVID-19 virus infection include asymptomatic infection, mild upper respiratory symptoms, severe viral pneumonia with respiratory failure, and even death. There are no antivirals of proven clinical efficacy in coronavirus infections. Remdesivir (GS-5734), a nucleoside analogue, has inhibitory effects on animal and human highly pathogenic coronaviruses, including MERS-CoV and SARS-CoV, in in vitro and in vivo experiments. It is also inhibitory against the COVID-19 virus in vitro. The aim of this study is to assess the efficacy and safety of remdesivir in adult patients with severe COVID-19. Methods: The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. This is a phase 3, randomized, double-blind, placebo-controlled, multicentre trial. Adults (≥ 18 years) with laboratory-confirmed COVID-19 virus infection, severe pneumonia signs or symptoms, and radiologically confirmed severe pneumonia are randomly assigned in a 2:1 ratio to intravenously administered remdesivir or placebo for 10 days. The primary endpoint is time to clinical improvement (censored at day 28), defined as the time (in days) from randomization of study treatment (remdesivir or placebo) until a decline of two categories on a six-category ordinal scale of clinical status (1 = discharged; 6 = death) or live discharge from hospital. One interim analysis for efficacy and futility will be conducted once half of the total number of events required has been observed. Discussion: This is the first randomized, placebo-controlled trial in COVID-19. Enrolment began in sites in Wuhan, Hubei Province, China on 6th February 2020. Trial registration: ClinicalTrials.gov: NCT04257656. Registered on 6 February 2020. © 2020 The Author(s).

AB - Background: Coronavirus disease 2019 (COVID-19), caused by a novel corinavirus (later named SARS-CoV-2 virus), was fistly reported in Wuhan, Hubei Province, China towards the end of 2019. Large-scale spread within China and internationally led the World Health Organization to declare a Public Health Emergency of International Concern on 30th January 2020. The clinical manifestations of COVID-19 virus infection include asymptomatic infection, mild upper respiratory symptoms, severe viral pneumonia with respiratory failure, and even death. There are no antivirals of proven clinical efficacy in coronavirus infections. Remdesivir (GS-5734), a nucleoside analogue, has inhibitory effects on animal and human highly pathogenic coronaviruses, including MERS-CoV and SARS-CoV, in in vitro and in vivo experiments. It is also inhibitory against the COVID-19 virus in vitro. The aim of this study is to assess the efficacy and safety of remdesivir in adult patients with severe COVID-19. Methods: The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. This is a phase 3, randomized, double-blind, placebo-controlled, multicentre trial. Adults (≥ 18 years) with laboratory-confirmed COVID-19 virus infection, severe pneumonia signs or symptoms, and radiologically confirmed severe pneumonia are randomly assigned in a 2:1 ratio to intravenously administered remdesivir or placebo for 10 days. The primary endpoint is time to clinical improvement (censored at day 28), defined as the time (in days) from randomization of study treatment (remdesivir or placebo) until a decline of two categories on a six-category ordinal scale of clinical status (1 = discharged; 6 = death) or live discharge from hospital. One interim analysis for efficacy and futility will be conducted once half of the total number of events required has been observed. Discussion: This is the first randomized, placebo-controlled trial in COVID-19. Enrolment began in sites in Wuhan, Hubei Province, China on 6th February 2020. Trial registration: ClinicalTrials.gov: NCT04257656. Registered on 6 February 2020. © 2020 The Author(s).

KW - Administrative information

KW - Antiviral

KW - China

KW - Clinical trial

KW - COVID-19

KW - Remdesivir

KW - adenosine phosphate

KW - alanine

KW - antivirus agent

KW - remdesivir

KW - Betacoronavirus

KW - Coronavirus infection

KW - double blind procedure

KW - drug effect

KW - equivalence trial (topic)

KW - female

KW - human

KW - intravenous drug administration

KW - male

KW - multicenter study (topic)

KW - pandemic

KW - pathogenicity

KW - patient safety

KW - phase 3 clinical trial (topic)

KW - risk assessment

KW - risk factor

KW - severity of illness index

KW - time factor

KW - treatment outcome

KW - virology

KW - virus pneumonia

KW - Adenosine Monophosphate

KW - Alanine

KW - Antiviral Agents

KW - Clinical Trials, Phase III as Topic

KW - Coronavirus Infections

KW - Double-Blind Method

KW - Equivalence Trials as Topic

KW - Female

KW - Humans

KW - Infusions, Intravenous

KW - Male

KW - Multicenter Studies as Topic

KW - Pandemics

KW - Patient Safety

KW - Pneumonia, Viral

KW - Risk Assessment

KW - Risk Factors

KW - Severity of Illness Index

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1186/s13063-020-04352-9

DO - 10.1186/s13063-020-04352-9

M3 - Journal article

VL - 21

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 422

ER -