Altamira Therapeutics’ (NASDAQ:CYTO) affiliate, Altamira Medica, has received the necessary approvals to initiate a clinical investigation of its Bentrio nasal spray in COVID-19 patients.
The COVAMID study is a randomized, placebo controlled clinical trial to evaluate the ability of Bentrio to reduce the SARS-CoV-2 viral load in the nose, alleviate COVID-19 signs and symptoms, and decrease the frequency of COVID-19 related hospital admissions.
In the study, 136 COVID-19 patients, confirmed with a positive PCR test, will be randomized at a 2:1:1 ratio to receive 10 days of either Bentrio, a placebo, or no treatment, followed by a 10-day observation phase.
Based on a planned blinded interim analysis, the number of participants may be increased to a maximum of 180 COVID-19 patients. The COVAMID study will start immediately in Bulgaria, and pending further approvals, may be extended to two additional countries.
“Multiple in vitro studies of Bentrio using human nasal epithelia cells infected with the SARS-CoV-2 virus or the H1N1 virus have demonstrated a significant reduction of the viral titer, with either prophylactic or therapeutic application,” Thomas Meyer, Altamira’s founder, chairman and CEO, said in a statement.
“We now look forward to testing Bentrio in the treatment of COVID-19 under clinical conditions to evaluate and confirm the effectiveness of its triple mode of action, which comprises the formation of a protective film on the nasal mucosa, the trapping of virus particles and the humidification of the mucosa,” he added.
