Quantum Leap Healthcare Collaborative (QLHC) has reported that famotidine celecoxib combination treatment failed to reduce time to recovery or mortality in critical Covid-19 patients in the I-SPY COVID Trial.
The combination agents, selected for evaluation due to their anti-histamine and anti-inflammatory properties, will be discontinued from the study over futility, based on the little chance of success.
An open-label, adaptive platform Phase II trial, I-SPY is being conducted to assess various therapies in critically ill Covid-19 patients on high-flow oxygen or mechanical ventilation.
The trial is intended to quickly identify therapies that can decrease time to recovery by 50%, as well as mortality risk.
Evaluation of famotidine celecoxib was conducted at 23 sites.
The combination met the futility criterion, determined as at least 90% possibility that the hazard ratio for time to recovery is under 1.5 versus the control arm, after enrolment of only 30 subjects.
Results from patients treated with famotidine celecoxib were compared with those from 36 participants simultaneously randomised to the control group, which included backbone therapy.
Subjects on the combination treatment were given backbone therapy along with a high dose of 80mg oral famotidine four times a day for seven days, and then a 40mg dose twice a day for two weeks and 400mg celecoxib twice daily for seven days.
Famotidine was provided by Johnson & Johnson while Pfizer supplied celecoxib.
A near final review showed that patients who received famotidine and celecoxib plus backbone therapy recovered slower compared with controls and could have an increased mortality rate.
Due to the possible harm to participants, the Data Monitoring Committee recommended dropping the arm earlier than the target enrolment needed to stop an arm for futility.
It was concluded that famotidine and celecoxib must not be administered with remdesivir and dexamethasone to treat severe Covid-19.
No new safety signals for high dose famotidine or celecoxib were reported in this trial population.
I-SPY COVID Trial co-investigator Dr Kashif Khan said: “The I-SPY COVID Trial demonstrated that, despite the promising mechanism of action and compelling data from observational studies, famotidine and celecoxib together did not improve recovery in patients critically ill with Covid-19.”
In April 2021, QLHC concluded the enrolment in the icatibant arm of the I-SPY COVID Trial.