Effectiveness of Rosuvastatin plus Colchicine, Emtricitabine/Tenofovir and a combination of them in Hospitalized Patients with SARS Covid-19

  1. Hernando Guillermo Gaitán-Duarte
  2. Carlos Álvarez-Moreno
  3. Carlos Javier Rincón-Rodríguez
  4. Nancy Yomayusa-González
  5. Jorge Alberto Cortés
  6. Juan Carlos Villar
  7. Juan Sebastián Bravo-Ojeda
  8. Ángel García-Peña
  9. Wilson Adarme-Jaimes
  10. Viviana Alejandra Rodríguez-Romero
  11. Steffany Lorena Villate-Soto
  12. Giancarlo Buitrago
  13. Julio Chacón-Sarmiento
  14. Martín Macías-Quintero
  15. Claudia Patricia Vaca
  16. Carlos Gómez-Restrepo
  17. Nelcy Rodríguez-Malagón
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Abstract

BACKGROUND

The effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir, and of their combined use in hospitalized patients with coronavirus disease 2019 (Covid-19) pneumonia is unclear.

METHODS

In each hospital, hospitalized adults with Covid-19 pneumonia, were randomly assigned, in a 1:1 ratio, to receive: a) standard of care; or b) emtricitabine/tenofovir; or c) colchicine + rosuvastatin; or d) emtricitabine/tenofovir + colchicine + rosuvastatin. The primary outcome was all-cause mortality within the first 28 days after randomization. Severe adverse events (SAE) were those with a high probability of being treatment-related.

RESULTS

633 patients were randomized in 6 hospitals in Bogota, Colombia. Overall, 98% of the patients received glucocorticoids during hospitalization. The cumulative incidence of death through day 28 was 10.7% in the emtricitabine/tenofovir + colchicine + rosuvastatin arm, 14.4% in the colchicine + rosuvastatin arm, 13.8% in the emtricitabine/tenofovir arm, and 17.4% in the standard of care arm, with adjusted risk differences (aRD) against the standard treatment of -0.07 (95% confidence interval [CI], -0.17 to 0.04), aRD -0.03 (95%CI: -0.11 to 0.05) and aRD: -0.05 (95%CI: -0.15 to 0.05), respectively. Need for invasive mechanical ventilation was lower in the emtricitabine/tenofovir + colchicine + rosuvastatin arm compared to the standard treatment arm, aRD: -0.06 (95%CI: -0.11 to -0,01), but no differences were found between the other comparisons. SAE occurred in 3 patients distributed in the 3 treatment arms.

CONCLUSIONS

Among patients hospitalized with moderate and severe SARS Covid-19, the use of the emtricitabine/tenofovir + colchicine + rosuvastatin combination emerges as a treatment alternative.

ClinicalTrials.gov number: <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT04359095">NCT04359095</ext-link>

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