Optimal thromboprophylaxis strategies in non-critically ill patients with COVID-19 pneumonia. The PROTHROMCOVID Randomized Controlled Trial

  1. Nuria Mu帽oz-Rivas
  2. Jes煤s Aibar
  3. Cristina Gabara-Xanc贸
  4. 脕ngela Trueba-Vicente
  5. Ana Urbelz-P茅rez
  6. Vicente G贸mez-Del Olmo
  7. Pablo Demelo-Rodriguez
  8. Alberto Rivera-Gallego
  9. Pau Bosch-Nicolau
  10. Montserrat Perez-Pinar
  11. M贸nica Rios-Prego
  12. Olga Madridano-Cobo
  13. Laura Ramos-Alonso
  14. Jes煤s Alonso-Carrillo
  15. Iria Francisco-Albelsa
  16. Edelmira Mart铆-Saez
  17. Ana Maestre-Peir贸
  18. Manuel M茅ndez-Bail贸n
  19. Jos茅 脕ngel Hern谩ndez-Rivas
  20. Juan Torres-Macho
  21. The PROTHROMCOVID Trial investigators
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Abstract

Background

Hospitalized patients with COVID-19 are at increased risk for thrombosis, acute respiratory distress syndrome and death. The optimal dosage of thromboprophylaxis is unknown.

Objective

To evaluate the efficacy and safety of tinzaparin in prophylactic, intermediate, and therapeutic doses in non-critical patients admitted for COVID-19 pneumonia.

Design, setting, and participants

Randomized controlled, multicenter trial (PROTHROMCOVID) enrolling non-critical, hospitalized adult patients with COVID-19 pneumonia.

Interventions

Patients were randomized to prophylactic (4500 IU), intermediate (100 IU/kg), or therapeutic (175 IU/kg) doses of tinzaparin during hospitalization, followed by 7 days of prophylactic tinzaparin at discharge.

Measurements

The primary efficacy outcome was a composite endpoint of symptomatic systemic thrombotic events, need for invasive or non-invasive mechanical ventilation, or death within 30 days. The main safety outcome was major bleeding at 30 days.

Results

Of the 311 subjects randomized, 300 were included in the analysis (mean [SD] age, 56.7 [14.6] years; males, 182 [60.7%]. The composite endpoint at 30 days from randomization occurred in 58 patients (19.3%) of the total population; 19 (17.1 %) in the prophylactic group, 20 (22.1%) in the intermediate group, and 19 (18.5%) in the therapeutic dose group (P= 0.72). No major bleeding event was reported; non-major bleeding was observed in 3.7% of patients, with no intergroup differences.

Conclusions

In non-critically ill COVID-19 patients, intermediate or full-dose tinzaparin compared to standard prophylactic doses did not appear to increase benefit regarding the likelihood of thrombotic event, non-invasive ventilation or high-flow oxygen, or death.

Trial Registration

<ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</ext-link> Identifier (<ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT04730856">NCT04730856</ext-link>).

Funding

This independent research initiative was supported by Leo-Pharma; Tinzaparin was provided by Leo Pharma.

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