Thalidomide for the treatment of severe Covid-19: A randomized clinical trial

Abstract Background Covid-19 pneumonia is the leading cause of death in severe hospitalized patients. Thalidomide has an immunomodulatory and anti-inflammatory effect and thereby decrease lung damage.Methods This study was a randomized clinical trial that was performed from April 2020 until August 2020 on 60 severe hospitalized Covid-19 pneumonia patients. All patients received the usual care for Covid-19 pneumonia based on our hospital protocols. Patients in the intervention group received thalidomide tablets 100 mg daily for 14 days added to the usual treatment. The primary outcome was the ICU admission rate.Results Thirty patients were assigned to receive thalidomide and 30 patients usual treatment. Five patients (17.9%) in the thalidomide group required ICU admission and 12 patients (52.2%) in the usual care group (P-value = 0.01). ICU admission hazard ratio was 3.3 higher in the usual care group than the thalidomide group (HR: 3.31 [95% CI: 1.16–9.45]). Hospitalization duration, intubation and mortality showed no significant differences between the two groups (P > 0.05 for all items). No serious and major adverse effects were reported during the trial.Conclusion The use of thalidomide was associated with a decreased rate of ICU admission in severe hospitalized covid-19 patients.