NCT04890626

Clinical Trial to Evaluate the Efficacy of Different Treatments in Patients With COVID-19

Completed Phase 3 Last updated 6 March 2024

What this trial tests

Phase 3 trial testing Emtricitabine/Tenofovir Disoproxil Fumarate 200 MG-245 MG Oral Tablet [TRUVADA] in SARS-CoV-2 Infection in 356 participants. Completed in 17 July 2023.

Timeline

4 April 2020

Primary endpoint
17 July 2023

17 July 2023

Quick facts

Lead sponsor	Instituto de Investigación Hospital Universitario La Paz
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	356
Start date	4 April 2020
Primary completion	17 July 2023
Estimated completion	17 July 2023
Sites	1 location across Spain

Drugs / interventions tested

• Emtricitabine/Tenofovir Disoproxil Fumarate 200 MG-245 MG Oral Tablet [TRUVADA] — full drug profile →
• Baricitinib + dexamethasone — full drug profile →
• Dexamethasone (dexamethasone) — full drug profile →

Conditions studied

• SARS-CoV-2 Infection — all drugs for SARS-CoV-2 Infection →

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Who can join

18 and older, any sex, with SARS-CoV-2 Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Currently COVID-19 is an international public health emergency. Most COVID-19 patients have mild or uncomplicated disease, but approximately 14% develop severe disease that requires hospitalization and oxygen therapy, and up to 5% of patients require admission to Intensive Care Units.

To date, the only treatments that have shown efficacy in a clinical trial are remdesivir and dexamethasone. The main objective is to provide reliable estimates on the effects of different treatment strategies on the outcome and mortality of patients with SARS-CoV-2 infection.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
2. Effect of Tenofovir Disoproxil Fumarate and Emtricitabine on nasopharyngeal SARS-CoV-2 viral load burden amongst outpatients with COVID-19: A pilot, randomized, open-label phase 2 trial.
   Parienti JJ, Prazuck T, Peyro-Saint-Paul L, Fournier A, et al · · 2021 · cited 49× · PMID 34222849 · DOI 10.1016/j.eclinm.2021.100993
3. Effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trial.
   Gaitán-Duarte HG, Álvarez-Moreno C, Rincón-Rodríguez CJ, Yomayusa-González N, et al · · 2022 · cited 29× · PMID 34957385 · DOI 10.1016/j.eclinm.2021.101242
4. Therapeutic implications of current Janus kinase inhibitors as anti-COVID agents: A review.
   Jain NK, Tailang M, Jain HK, Chandrasekaran B, et al · · 2023 · cited 24× · PMID 37021053 · DOI 10.3389/fphar.2023.1135145
5. Inhibition of the JAK/STAT Pathway With Baricitinib Reduces the Multiple Organ Dysfunction Caused by Hemorrhagic Shock in Rats.
   Patel NM, Collotta D, Aimaretti E, Ferreira Alves G, et al · · 2023 · cited 20× · PMID 35837955 · DOI 10.1097/sla.0000000000005571
6. The Role of Cyclodextrins in COVID-19 Therapy-A Literature Review.
   Almeida B, Domingues C, Mascarenhas-Melo F, Silva I, et al · · 2023 · cited 17× · PMID 36769299 · DOI 10.3390/ijms24032974
7. Recent clinical findings on the role of kinase inhibitors in COVID-19 management.
   Malekinejad Z, Baghbanzadeh A, Nakhlband A, Baradaran B, et al · · 2022 · cited 15× · PMID 35841979 · DOI 10.1016/j.lfs.2022.120809
8. Pulmonary Inflammatory Response in Lethal COVID-19 Reveals Potential Therapeutic Targets and Drugs in Phases III/IV Clinical Trials.
   López-Cortés A, Guerrero S, Ortiz-Prado E, Yumiceba V, et al · · 2022 · cited 12× · PMID 35422702 · DOI 10.3389/fphar.2022.833174