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
Qualifiers
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
Treatments tested in this trial
- Valacyclovir
- Celecoxib
- Paxlovid
- Placebo
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov