Ampio Pharmaceuticals has secured Investigational Review Board (IRB) approval for its Phase I trial against long-haul Covid-19.
Named AP-018, the trial will assess the use of inhaled Ampion to treat patients with prolonged respiratory Covid-19 symptoms or Post-Acute Sequelae of SARS-CoV-2. Enrolment is set to begin soon.
It will study the therapeutic’s safety and efficacy in 30 adults with a confirmed Covid-19 diagnosis and a minimum of two respiratory symptoms related to the disease.
Participants will receive a nebuliser for use at home for five days and will be followed for 60 days after treatment.
The trial’s primary endpoint is the incidence and severity of adverse events (AEs) and serious AEs from baseline to days 28 and 60.
Exploratory efficacy endpoints will compare inhaled Ampion to placebo on the clinical outcomes in individuals with long-haul respiratory Covid-19 complications.
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Ampio Pharmaceuticals president and CEO Michael Macaluso said: “A significant percentage of patients who have contracted Covid-19 over the past year, even those with mild or asymptomatic cases, continue to suffer debilitating effects long after there is no detectable virus in their system.
“These symptoms stem from the out-of-control inflammatory immune response the virus triggers, something Ampion may be able to address.”
Last month, all participants in the company’s Phase I AP-014 trial of inhaled Ampion completed treatment against Covid-19, including a follow-up at day 28 following treatment.
The primary endpoint of safety and tolerability was met. Final results revealed that Ampion led to a 78% decrease in all-cause mortality for Covid-19 respiratory distress compared to the standard of care (SOC).
Mortality was 5% in the Ampion arm versus 24% in the SOC group.