Protocol Paxlovid for Treatment of Long Covid (STOP-PASC), 2022, Singh et al, Stanford University - recruitment stopped June 2023

[Kalliope]

Medpage Today Stanford Study of Paxlovid for Long COVID Stopped Early

Quote:
Two sources familiar with the STOP-PASC study told MedPage Today that trial enrollment had been halted. One was told by a study coordinator that a preliminary review found "inconclusive evidence" for the primary outcome of the study. Another said their first appointment was canceled just a few days before it was supposed to take place, and they were later told that all future enrollment had been halted.

 

[Trish]

From the Protocol:

Paxlovid for Treatment of Long Covid (STOP-PASC)
Brief Summary:
The purpose of this study is to compare whether being treated with Paxlovid (nirmatrelvir plus ritonavir) for 15 days works better than being treated with placebo (plus ritonavir) to reduce severe symptoms of Long Covid (the placebo does not have any active drug).

Participants will have 5 planned visits to the study clinic over 15 weeks and will take the drug (or placebo) for the first 15 days.

This study uses the term post-acute sequelae of SARS-CoV-2 (PASC), which is another name for "Long Covid."
Study Design

Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Selective Trial Of Paxlovid for PASC (STOP-PASC): Randomized Double-Blind Placebo-Controlled Pilot Trial of Paxlovid for the Treatment of PASC
Actual Study Start Date : November 8, 2022
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : November 2023

 

[RedFox]

Was it stopped because it was ineffective?

 

[Trish]

There's a much bigger phase 3 study as part of RECOVER being run by Duke University. See this thread:
RECOVER Treatment Study: Paxlovid for long Covid

There's also the Iwasaki (Yale) trial. See this thread.
Protocol A Decentralized, Randomized Phase 2 Efficacy and Safety Study of Nirmatrelvir/Ritonavir [Paxlovid] in Adults With Long COVID, 2023, Iwasaki el al.

I wonder whether the early stop on this Stanford trial will impact those other 2 trials.

 

[Trish]

Was it stopped because it was ineffective?

That's what the Medpage article seems to indicate from the bit Kalliope quoted.

 

[Kalliope]

There's a much bigger phase 3 study as part of RECOVER being run by Duke University. See this thread:
RECOVER Treatment Study: Paxlovid for long Covid

There's also the Iwasaki (Yale) trial. See this thread.
Protocol A Decentralized, Randomized Phase 2 Efficacy and Safety Study of Nirmatrelvir/Ritonavir [Paxlovid] in Adults With Long COVID, 2023, Iwasaki el al.

I wonder whether the early stop on this Stanford trial will impact those other 2 trials.

There is also one taking place in Sweden with 400 participants titled imPROving Quality of Life In the Long COVID Patient (PROLIFIC)

 

[Trish]

The article from medpage is on this archive site:
https://archive.fo/EWHGn

Stanford Medicine spokesperson Lisa Kim confirmed that "new enrollment is closing slightly earlier than original projections based on a planned interim analysis reviewed by an external monitoring committee."
"There are no safety concerns with the study and enrolled participants are encouraged to complete follow-up activities as planned," she added.
Kim did not provide further comment on what was found during the interim analysis and did not comment on the "inconclusive" results mentioned by the study coordinator to the source.

In May, MedPage Today reported that some participants were concerned that some investigators were not wearing masks during clinic visits, potentially putting the participants at risk.
According to ClinicalTrials.gov, the study design specified two-way masking, for both investigators and participants. Neither Stanford nor study sponsor Pfizer would comment on whether or not the masking issue factored into the decision to stop the study early.

 

[wingate]

Does anyone know of any updates regarding the 'interim analysis' of the trial data? The MedPage article above is almost a year old now.

There's a much bigger phase 3 study as part of RECOVER being run by Duke University. See this thread:
RECOVER Treatment Study: Paxlovid for long Covid

There's also the Iwasaki (Yale) trial. See this thread.
Protocol A Decentralized, Randomized Phase 2 Efficacy and Safety Study of Nirmatrelvir/Ritonavir [Paxlovid] in Adults With Long COVID, 2023, Iwasaki el al.

I wonder whether the early stop on this Stanford trial will impact those other 2 trials.

I'm with you @Trish about the impact to the RECOVER trial. If the study was indeed halted because the drug was found to be ineffective then why is RECOVER trying a similar protocol?

 

[EndME]

Does anyone know of any updates regarding the 'interim analysis' of the trial data? The MedPage article above is almost a year old now.

I'm with you @Trish about the impact to the RECOVER trial. If the study was indeed halted because the drug was found to be ineffective then why is RECOVER trying a similar protocol?

They have held presentations at various conferences for the past year with words along the lines of "results could be out anyday". Yale recently declared that they wanted to announce results this June so both results could be out anyday now, the same applies to the results by Karolinska Institutet, but I'm not holding my breath...

 

[RedFox]

This trial was completed and found Paxlovid didn't help. Source: Paxlovid fails to improve long-COVID symptoms in small study