News: Pfizer oral therapy reduces Covid mortality risk
Interim data has been released from Pfizer’s Phase II/III clinical trial of oral COvid-19 therapy, called Paxlovid. In the trial, the drug was found to significantly reduce Covid-19 related mortality and hospitalization.
Paxlovid is an experimental inhibitor of an enzyme that is required for the virus to replicate. This phase of the trial was a double-blind, randomized trial that enrolled non-hospitalized adult subjects with Covid that were at an increased risk of disease progression or adverse effects from Covid.
Participants were given either Paxlovid or a placebo every 12 hours for five days, and results were gathered from over 1,200 patients who began enrollment at the end of September.
Patients who received the Paxlovid treatment saw an 89% decrease in Covid-19 related hospitalization or mortality risk versus the placebo. Further, 0.8% of subjects in the group receiving Paxlovid were admitted to the hospital by day 28 versus 7% in the placebo group (7% being the number that either died or were hospitalized.)
Similar results were found in a group beginning the treatment within five days of symptom development. Only 1% of these patients were hospitalized by seven days, versus 6.7% of the placebo group (this indicates even greater statistical significance than in the later-dosed group.)
Pfizer is continuing to submit this evidence to the FDA for emergency use Authorization, and the company hopes that if approved their drug could reduce suffering and mortality, and even prevent up to nine out of ten hospitalizations due to Covid-19.
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In addition to keeping you up to date on all things clinical trials, we also act as a digital CRO with a specific focus on patient recruitment and retention. We believe that patient recruitment and study startup (especially study design and study material) are heavily intertwined. After all, study design can make or break clinical trials, and the patient-perspective should be considered when designing studies to ensure that patient targets are met not only on time, but also on budget.
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