Telmisartan for treatment of Covid-19 patients: an open randomized clinical trial. Preliminary report.

Duarte, M.; Pelorosso, F. G.; Nicolosi, L.; Salgado, M. V.; Vetulli, H.; Aquieri, A.; Azzato, F.; Basconcel, M.; Castro, M.; Coyle, J.; Davolos, I.; Esparza, E.; Fernandez Criado, I.; Gregori, R.; Mastrodonato, P.; Rubio, M.; Sarquis, S.; Wahlmann, F.; Rothlin, R. P.

Background. Covid-19, the disease caused by SARS-CoV-2, is associated with significant respiratory-related morbidity and mortality. Angiotensin receptor blockers (ARBs) have been postulated as tentative pharmacological agents to treat Covid-19-induced lung inflammation. Trial design. This trial is a parallel group, randomized, two arm, open label, multicenter superiority trial with 1:1 allocation ratio. Methods. Participants included patients who were 18 years of age or older and who had been hospitalized with confirmed Covid-19 with 4 or fewer days since symptom onset. Exclusion criteria included intensive care unit admission prior to randomization and use of angiotensin receptor blocker or angiotensin converting enzyme inhibitors at admission. Participants in the treatment arm received telmisartan 80 mg bid during 14 days plus standard care. Participants in the control arm received standard care alone. Primary outcome was to achieve significant reductions in plasma levels of C-reactive protein in telmisartan treated Covid-19 patients at day 5 and 8 after randomization. Key secondary outcomes included time to discharge evaluated at 15 days after randomization and admission to ICU and death at 15- and 30-days post randomization. We present here a preliminary report. Results. A total of 78 patients were included in the interim analysis, 40 in the telmisartan and 38 in the control groups. CRP levels at day 5 in the control group were 51.1 +/- 44.8 mg/L (mean +/- SD; n=28) and in the telmisartan group were 24.2 +/- 31.4 mg/L (mean +/- SD; n=32, p<0.05). At day 8, CRP levels were 41.6 +/- 47.6 mg/L (mean +/- SD; n=16) and 9.0 +/- 10.0 mg/L (mean +/- SD; n=13, p < 0.05) in the control and telmisartan groups, respectively. Also, analysis of time to discharge by Kaplan-Meier method showed that telmisartan treated patients had statistically significant lower time to discharge (median time to discharge control group=15 days; telmisartan group=9 days). No differences were observed for ICU admission or death. No significant adverse events related to telmisartan were reported. Conclusions. In the present preliminary report, despite the small number of patients studied, ARB telmisartan, a well-known inexpensive safe antihypertensive drug, administered in high doses, demonstrates anti-inflammatory effects and improved morbidity in hospitalized patients infected with SARS -CoV-2, providing support for its use in this serious pandemia (NCT04355936).