Atorvastatin and telmisartan do not reduce nasopharyngeal carriage of SARS-CoV-2 in mild or moderate COVID-19 in a phase IIb randomized controlled trial

• Published in: Scientific reports Vol. 14; no. 1; pp. 25028 - 9
• Main Authors: Bonnet, Fabrice, Doumbia, Adama, Machault, Vanessa, Ello, Frederic Nogbou, Bellecave, Pantxika, Akpovo, Corine Bernice, Sidibe, Baba Toumany, Fernandez, Laura, Kouamé, Antoine, Adjogoua, Edgard, Dosso, Mireille, Niangoran, Serge, Journot, Valérie, Eholié, Serge Paul
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 23-10-2024; Nature Publishing Group; Nature Portfolio
• Subjects: 692/308; 692/53; ACE2; Adult; Aged; Angiotensin-converting enzyme 2; Antiviral Agents - therapeutic use; Atorvastatin; Atorvastatin - administration & dosage; Atorvastatin - therapeutic use; C-reactive protein; COVID-19; COVID-19 - virology; COVID-19 Drug Treatment; Female; Humanities and Social Sciences; Humans; Inflammation; Lopinavir; Male; Middle Aged; multidisciplinary; Nasopharynx - virology; NCT; NCT04466241; Observational studies; Patients; Randomized controlled trial; Ritonavir; SARS-CoV-2; SARS-CoV-2 - drug effects; SARS-CoV-2 - isolation & purification; Science; Science (multidisciplinary); Severe acute respiratory syndrome coronavirus 2; Statins; Telmisartan; Telmisartan - administration & dosage; Telmisartan - therapeutic use; Viral Load - drug effects; Atorvastatin; SARS-CoV-2; Randomized controlled trial; Telmisartan
• ISSN: 2045-2322; 2045-2322
• DOI: 10.1038/s41598-024-72449-1

Observational studies suggest a reduction in fatal or severe COVID-19 disease with the use of ACE2 inhibitors and statins. We implemented a randomized controlled tree-arm open label trial evaluating the benefits of adding telmisartan (TLM) or atorvastatin (ATV) to lopinavir boosted ritonavir (LPVr) on the SARS-CoV-2 nasopharyngeal viral load in patients with mild / moderate COVID-19 infection in Côte d’Ivoire. RT-PCR positive COVID-19 patients ≥ 18 years, with general or respiratory symptoms for less than 7 days were randomized (1:1:1) to receive LPVr (400 mg/100 mg twice daily), LPVr + TLM (10 mg once daily) or LPVr + ATV (20 mg once daily) for 10 days. The primary endpoint was viro-inflammatory success defined as a composite variable at day 11: Ct ≥ 40 and C-reactive protein < 27 mg/L. We randomized 294 patients: 96 to LPVr, 100 to LPVr + TLM, 98 to LPVr + ATV arms. Baseline characteristics were well balanced between arms. In the primary analysis (missing = failure), 46% patients in the LPVr arm reached viro-inflammatory success at day 11 vs 43% in the LPVr + TLM arm (p = 0.69) and 43% in the LPVr + ATV arm (p = 0.68). The median time from baseline to resolution of COVID-19 related symptoms was not different between arms. Nine patients were hospitalized: 2 in the LPVr arm, 5 in the LPVr + TLM arm and 2 in the LPVr + ATV arm and 4 patients died. Among adults with mild to moderate COVID-19 infection, the addition of telmisartan or atorvastatin, to the standard LPVr treatment is not associated with a better virological or clinical outcome.
Trial registration:
NCT04466241, registered on 10/07/2020