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Repurposed immunomodulatory drugs for Covid-19 in pre-ICu patients - mulTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19 - Repurposed Drugs (TACTIC-R): A structured summary of a study protocol for a randomised controlled trial.


ABSTRACT:

SUBMITTER: Kulkarni S 

PROVIDER: S-EPMC7341462 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Repurposed immunomodulatory drugs for Covid-19 in pre-ICu patients - mulTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19 - Repurposed Drugs (TACTIC-R): A structured summary of a study protocol for a randomised controlled trial.

Kulkarni Spoorthy S   Fisk Marie M   Kostapanos Michalis M   Banham-Hall Edward E   Bond Simon S   Hernan-Sancho Elena E   Norton Sam S   Cheriyan Joseph J   Cope Andrew A   Galloway James J   Hall Frances F   Jayne David D   Wilkinson Ian B IB  

Trials 20200708 1


<h4>Objectives</h4>To determine if a specific immunomodulatory intervention reduces progression of COVID-19-related disease to organ failure or death, compared to standard of care (SoC).<h4>Trial design</h4>Randomised, parallel 3-arm (1:1:1 ratio), open-label, Phase IV platform trial of immunomodulatory therapies in patients with late stage 1 or stage 2 COVID-19-related disease, with a diagnosis based either on a positive assay or high suspicion of COVID-19 infection by clinical and/or radiologi  ...[more]

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