SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-65 years of age at the time of study entry
Diagnosed with Long COVID
Individuals of child-bearing potential must have a negative serum pregnancy test at screening and agree to on-site urine pregnancy testing at all subsequent study visits
A urine drug screen performed at the Screening Visit must be negative for drugs of abuse such as methamphetamine, cocaine, phencyclidine (PCP), and non-disclosed amphetamines and opioids/opiates.
Disqualifiers
Breastfeeding, pregnant, or planning to become pregnant during the next six months.
In the opinion of the Investigator, any clinically significant, uncontrolled, or unstable medical or surgical condition that could affect the individual's ability to participate in the study or potentially compromise their well-being while enrolled in the study.
In the opinion of the Investigator or based on results of the HADS, evidence of a clinically significant psychiatric disorder, e.g., severe, unstable or poorly controlled depression, anxiety or obsessive-compulsive disorder; moderate or severe alcohol use disorder; substance use disorder other than mild cannabis use disorder; or any history of bipolar disorder, schizophrenia, schizoaffective disorder or other psychotic disorder.
Currently meeting criteria for ME/CFS at the pre-screening or screening visit, or a prior confirmed diagnosis of ME/CFS within the last 5 years. This may be determined as part of the initial screening call or visit.
Trial design
Design model
Parallel
Treatments tested in this trial
Valacyclovir
Drugone to two 750mg capsules taken orally in the morning and evening
Celecoxib
Drug200mg capsules taken orally in the morning and evening
Paxlovid
Drugone (100mg ritonavir tablet and two 150mg nirmatrelvir tablets) taken orally in the morning and evening
Placebo
Drugmatching placebo capsules and tablets taken orally in the morning and evening
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Combination Drug TherapyExperimental treatment 3 interventions
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
EQ-5D-5L Visual Analogue Scale (VAS)
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 20Secondary outcomes
1
The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L)
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 202
Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29)
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 203
General Symptom Questionnaire (GSQ-30)
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 204
Patient Health Questionnaire (PHQ-9)
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 20Sponsors and contacts
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Source ClinicalTrials.gov
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