Your session is about to expire
← Back to Search
Antiviral Agent
Nirmatrelvir + Ritonavir for Long COVID (PAXLC Trial)
Phase 2
Waitlist Available
Led By Harlan Krumholz, MD
Research Sponsored by Harlan M Krumholz
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Baseline 'fair' or worse general health status and 'good' or better before the index infection with no obvious other reason for the depressed general health status
Symptoms consistent with long COVID that began within 4 weeks of the index infection and persisted for >12 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28 and at day 15, and weeks 6, 10, 14, 18 and 24
Awards & highlights
PAXLC Trial Summary
This trial will test an anti-viral agent to improve general health status in people with long COVID, and will also collect immune signatures associated with treatment response. It is designed to make it convenient to participate.
Who is the study for?
Adults with long COVID, who had 'fair' or worse health after COVID-19 and were healthier before. They must have a positive PCR test for past infection, be over 18, speak English well, live in CT, FL, or NY, and can consent to study procedures. Excluded are those treated with nirmatrelvir/ritonavir recently, with certain liver diseases or hypersensitivities, HIV+, seriously ill recently or hospitalized/scheduled for surgery soon.Check my eligibility
What is being tested?
The trial tests Paxlovid (nirmatrelvir/ritonavir) against a placebo to see if it improves health in non-hospitalized adults with long COVID. It's randomized and double-blind: participants won't know which treatment they get. The study is decentralized; no site visits needed as drugs are mailed directly.See study design
What are the potential side effects?
Possible side effects of Paxlovid include taste disturbances (dysgeusia), diarrhea, high blood pressure (hypertension), muscle aches (myalgia), and nausea. Side effects vary by individual.
PAXLC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My health was good before my recent infection, but now it's fair or worse without other causes.
Select...
I have had long COVID symptoms for more than 12 weeks.
PAXLC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 28 and at day 15, and weeks 6, 10, 14, 18 and 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28 and at day 15, and weeks 6, 10, 14, 18 and 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS)-29 version 2.1 Physical Health Summary Score
Secondary outcome measures
COVID Core Outcome Measure for Recovery
Difference in number of hospitalizations and deaths
EuroQol EQ-5D-5L Utility Score-VAS (USA Version)
+8 moreOther outcome measures
Exploratory Outcome Measure
PAXLC Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nirmatrelvir / RitonavirExperimental Treatment2 Interventions
Participants receive nirmatrelvir plus ritonavir (Paxlovid) for 15 days. All 3 tablets (2 of nirmatrelvir and 1 of ritonavir) must be taken twice daily by mouth for 15 days.
Group II: Placebo / RitonavirPlacebo Group2 Interventions
Participants receive placebo to match nirmatrelvir plus ritonavir for 15 days. The control formulation includes 2 placebo tablets and 1 ritonavir tablet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nirmatrelvir
2022
Completed Phase 2
~330
Ritonavir
2005
Completed Phase 4
~2200
Find a Location
Who is running the clinical trial?
Harlan M KrumholzLead Sponsor
PfizerIndustry Sponsor
4,568 Previous Clinical Trials
10,911,786 Total Patients Enrolled
68 Trials studying COVID-19
1,438,683 Patients Enrolled for COVID-19
Harlan Krumholz, MDPrincipal InvestigatorYale University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a long-term health condition that severely affects my daily life.I have not had any serious illnesses, including COVID-19, in the last 2 weeks.I have a regular doctor or clinic where I receive my medical care.I have had long COVID symptoms for more than 12 weeks.I am 18 or older and considered an adult in my state.You have a weakened immune system as defined by the CDC.My health was good before my recent infection, but now it's fair or worse without other causes.I haven't been hospitalized or had surgery for a serious condition in the last 7 days.I am taking or will take medication that is mainly processed by the liver.I haven't taken nirmatrelvir/ritonavir in the last 2 months or for more than 5 days.I have a history of serious liver disease or hepatitis.You have tested positive for HIV.You have had certain health issues in the past 6 months or currently have them.You must have had a confirmed case of COVID-19 with a positive PCR test or medical records to show the infection.I am not taking any strong CYP3A4 inducers.I am on dialysis or have kidney problems with a low eGFR.You are not planning to get a COVID-19 vaccine from the time you agree to join the study until 28 days later.
Research Study Groups:
This trial has the following groups:- Group 1: Nirmatrelvir / Ritonavir
- Group 2: Placebo / Ritonavir
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Food and Drug Administration sanctioned Nirmatrelvir / Ritonavir as a pharmaceutical treatment?
"Despite the lack of evidence for Nirmatrelvir / Ritonavir's efficacy, clinical data suggests that it is relatively safe and thus merits a score of 2."
Answered by AI
Is this experiment still accepting participants?
"Affirmative. The clinicaltrials.gov registry states that this investigation is actively recruiting participants, having been posted on April 1st 2023 and last updated a few days ago. This research requires 100 volunteers from one site for enrolment."
Answered by AI
What is the current allotment of participants for this trial?
"Affirmative, the information available on clinicaltrials.gov attests to this medical study's ongoing recruitment efforts. This trial was first advertised on April 1st 2023 and has received its last update ten days ago. At present, 100 individuals are needed for participation at a single location."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger