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. 2023 Jun 28;24:435. doi: 10.1186/s13063-023-07448-0
Title {1} Phase 2b randomized double-blind, placebo-controlled trial to estimate the potential efficacy and safety of two repurposed drugs, acetylsalicylic acid and ibuprofen, for use as adjunct therapy added to, and compared with, the standard WHO recommended TB regimen
Trial registration {2a, 2b} The study protocol has been registered in clinicaltrials.gov identified with NCT04575519 on 5 October 2020 https://clinicaltrials.gov/ct2/show/NCT04575519
Protocol version {3} Version 5.0 of 8 September 2021
Funding {4} This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 847762
Author details {5}

1 Unitat de Tuberculosi Experimental, Germans Trias i Pujol Research Institute (IGTP), Badalona, Catalonia, Spain.

2 Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain.

3 Perinatal HIV Research Unit (PHRU), University of the Witwatersrand, Johannesburg, South Africa.

4 National Center for Tuberculosis and Lung Diseases (NCTLD), Tbilisi, Georgia.

5 Institut d’Investigació en Atenció Primària de Salut Jordi Gol (IDIAPJgol), Barcelona, Spain.

6 Pharmacy department, Germans Trias i Pujol Hospital and Research Institute (HUGTIP-IGTP), Badalona, Catalonia, Spain.

7 The University of Georgia, Tbilisi, Georgia.

8Microbiology Department, Northern Metropolitan Clinical Laboratory, Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, Spain.

9 Direcció Clínica Territorial de Malalties Infeccioses i Salut Internacional de Gerència Territorial Metropolitana Nord. Badalona, Catalonia, Spain.

Name and contact information for the trial sponsor {5b}

Cristina Vilaplana,

Fundació Institut d’Investigació en Ciències de la Salut Germans Trias i Pujol (IGTP)

Carretera de Can Ruti, Camí de les Escoles s/n, 08916 Badalona, Barcelona, Spain

cvilaplana@igtp.cat

 + 34 93 033 05 27

Role of sponsor {5c} The sponsor of the CT is the Fundació Institut Germans Trias i Pujol (IGTP), coordinator of the H2020-funded project within this CT is conducted (“A novel Stratified Medicine Algorithm to predict treatment responses to host-directed therapy in TB patients (SMA-TB)” www.smatb.eu, Grant Agreement (GA) 847,762). Contact for the CT sponsor is Dr Cristina Vilaplana, MD, PhD, the project leader of SMA-TB project and acts as coordinating investigator of the CT. She conceived the CT in collaboration with other authors as reported in names and roles of protocol contributors. The funders of the CT had no role in the conceptualization, study design, data collection, management, analysis, and interpretation of the findings. The EC recommended the submission of the protocol for publication and obliges the publication of the results of the CT whenever they become available, encouraging Open Science publication.