Altamira Therapeutics has reached the target enrolment of 136 participants in its COVAMID clinical trial analysing the Bentrio nasal spray in acute Covid-19 patients.
An over the counter (OTC) drug-free nasal spray, Bentrio is said to offer protection from allergens and airborne viruses.
Being carried out in Bulgaria and North Macedonia, the placebo-controlled, randomised trial will assess the safety, tolerability and efficacy of the Bentrio nasal spray in acute Covid-19 patients.
Furthermore, the potential of Bentrio will be evaluated to cut down the SARS-CoV-2 viral load in the nose, reduce signs and symptoms of Covid-19 and reduce the occurrence of hospitalisations linked to Covid-19.
Participants will be categorised into a 2:1:1 ratio to receive either Bentrio or a placebo or no treatment for ten days.
These subjects will be followed up for another ten days in the observation phase.
After concluding the data entry and verification, the company will carry out a pre-specified blinded interim assessment to check if the preliminary assumptions for the statistical powering of the trial have been satisfied.
On confirming this, Altamira plans to report top-line findings from the trial in the third quarter of this year.
If the interim analysis indicates that a bigger sample size is needed, the company will continue subject enrolment to up to 180 patients and the top-line findings will be reported in the fourth quarter of this year.
On obtaining positive data from the trial, the company intends to seek a product label expansion for Bentrio to include viral infections in regions needing supportive clinical data.
Altamira Therapeutics founder, chairman and CEO Thomas Meyer said: “After having already demonstrated Bentrio’s effectiveness and utility in several clinical studies in allergic rhinitis, this is a significant milestone in our clinical development of Bentrio in viral infections.
“Given its unique triple mode of action and versatility against various types of viruses, we consider Bentrio well-positioned to help protect people in a world with many challenges from existing or evolving airborne viruses.”