Clinical trial for Post-acute Sequelae of COVID-19
Official title SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction
ClinicalTrials.gov ID: NCT07597902
What this study is testing
What is Valacyclovir?
an investigational oral antiviral being studied as a potential treatment for post‑acute sequelae of COVID‑19 (Long COVID). is designed to be converted to acyclovir in the body, which then inhibits viral DNA polymerase and blocks viral replication.
Also referred to as Valtrex.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether the combination of valacyclovir, celecoxib, and Paxlovid reduces Long COVID symptoms compared to a pretend treatment.
- Who it's for
- You may be able to join if you are an adult who has Long COVID.
- What's involved
- You would take three medicines: valacyclovir (an antiviral), celecoxib (an anti‑inflammatory), and Paxlovid (an antiviral). You might also take a pretend treatment that has no medicine.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- A urine drug screen performed at the Screening Visit must be negative for drugs of abuse such as methamphetamine, cocaine, phencyclidine (PCP), and...
- Those with mild to moderate depression should be clinically stable for three months, without risk of suicidal ideation or behavior.
You likely can't join if
- 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...
- In the opinion of the Investigator or based on results of the HADS, evidence of a clinically significant psychiatric disorder, e.g., severe, unstable...
- 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.
- Any anticipated need for surgery that in the opinion of the Principal Investigator or Sub-I might confound results or interfere with the...
- Symptomatic and/or otherwise clinically significant cardiac disease
See the full eligibility criteria
- 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.
- Those with mild to moderate depression should be clinically stable for three months, without risk of suicidal ideation or behavior.
- 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...
- 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...
- 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.
- Any anticipated need for surgery that in the opinion of the Principal Investigator or Sub-I might confound results or interfere with the participant's ability to comply with the protocol.
- Symptomatic and/or otherwise clinically significant cardiac disease
- Acute non-COVID systemic infection (e.g., HIV, hepatitis) or other active viral or bacterial infection during the screening/washout period or at the Baseline visit.
- Currently receiving chronic systemic corticosteroids (\>5 mg prednisone daily, or equivalent)
- Routine treatment with warfarin, heparin, lithium, digoxin, amiodarone, isoniazid, phenytoin, fluconazole, methotrexate, probenecid, or raloxifene. Participants on these medications should not be screened.
- Uncontrolled sleep apnea.
- Use of chronic nucleoside analog antiviral suppression therapy within one month of the Screening Visit or requiring on average more than one acute treatment course every two months.
- Current use of celecoxib either alone or in combination with valacyclovir or famciclovir
- In the opinion of the Investigator, evidence of current drug or alcohol abuse or dependency, or history of abuse or dependence during the preceding 12 months.
- The participant has undergone a malabsorptive weight loss procedure (e.g., Roux-en-Y or other bypass procedure).
- Severe IBS-C or colonic inertia as evidenced by seven or more days between bowel movements.
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.