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.
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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.
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By GlobalDataAfter 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.”
