The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, 10029, United States
NCT Number: NCT07597902
The purpose of this research study is to test if the combination of three drugs, valacyclovir, celecoxib, and Paxlovid will decrease the symptoms of Long COVID in adults compared to a placebo (this does not contain the medications).
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Phase 2
New York, 10029, United States
This is an off-label, randomized, double-blind, active placebo-controlled, two-arm clinical trial of a combination of celecoxib, valacyclovir, and Paxlovid in adults with Long COVID. This study aims to evaluate the safety and efficacy of the combination of celecoxib, valacyclovir, and Paxlovid in adults with Long COVID (LC). Safety will be primarily measured through blood and urine measures. Efficacy will be evaluated by measuring patient-reported outcomes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
one to two 750mg capsules taken orally in the morning and evening
200mg capsules taken orally in the morning and evening
one (100mg ritonavir tablet and two 150mg nirmatrelvir tablets) taken orally in the morning and evening
matching placebo capsules and tablets taken orally in the morning and evening
Time frame: Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20
The EQ VAS records the patient's self-rated health on a visual analogue scale where the endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0), with higher scores indicating better health state. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Time frame: Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20
The EQ-5D-5L is a validated, standardized, generic instrument that is a preference-based health- related quality of life questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Full scale from 5 to 25, with higher score indicating poorer health outcomes.
Time frame: Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20
The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. The values of all item responses are averaged to generate subscores for each dimension. From these subscores, a global physical health score and a global mental health score are generated. The scores are translated into T-scores according to a reference population with a mean of 50 and a standard deviation of 10.
Time frame: Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20
The General Symptom Questionnaire-30 (GSQ-30) is a valid and reliable instrument to assess symptom burden among patients with acute and post-treatment. The GSQ-30 total score ranges from 0 to 120, with higher scores indicating a greater symptom burden.
Time frame: Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20
The PHQ-9 is a series of questions assessing presence and severity of depression symptoms. It evaluates each of the DSM-IV depression criteria and scores the responses from 0 ("Not at all") to 3 ("Nearly every day"). PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Full scale from 0-27, with higher score indicating more severe symptoms.
Time frame: Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20
The GAD-7 is a 7-item scale developed and validated to identify generalized anxiety disorder and its severity. It assesses the frequency of 7 anxiety symptoms and scores the responses from 0 ("Not at all") to 3 ("Nearly every day"). Total scores of 5, 10, and 15 correspond to mild, moderate, and severe generalized anxiety disorder, respectively. Full scale from 0-21, with higher score indicating more symptoms.
Time frame: Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20
A suicide risk assessment tool that supports suicide risk assessment through a series of simple, plain-language questions that anyone can ask. The answers help users identify whether someone is at risk for suicide, assess the severity and immediacy of that risk, and gauge the level of support that the person needs.
Full range from 0 (low intensity suicidal ideation to 9 (high intensity suicidal ideation). Higher score represents poorer health outcomes.
Time frame: Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20
The Neuro-QoL Cognitive Function v2.0 short form assesses perceived difficulties in cognitive abilities, including memory, attention, decision making, planning, organizing, calculating, remembering, and learning. The short form consists of 8 questions assessed on a 5-point Likert scale, resulting in a raw score range of 8 to 40. A raw score is then converted to a T-score using conversion tables. Scores 0.5 - 1.0 SD worse than the mean (T-score 40-45) = mild symptoms/impairment. Scores 1.0 - 2.0 SD worse than the mean (T-score 30-40) = moderate symptoms/impairment. Scores 2.0 SD or more worse than the mean (T-score below 30) = severe symptoms/impairment.
Time frame: Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20
The SQS is a visual analog scale that instructs respondents to rate their overall quality of sleep over a 7-day recall period from 0 to 10. Scores of 0, 1, 4, 7, and 10 correspond to terrible, poor, fair, good, and excellent, respectively. Higher scores indicate better sleep quality.
Contact information is provided by the study sponsor or research team.
Icahn School of Medicine at Mount Sinai
Other
SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction (SHIELD)
Acronym: SHIELD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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