Recruiting
Phase 2

Valacyclovir, Celecoxib, Paxlovid

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07597902

Conditions

Post-acute Sequelae of COVID-19

Long COVID

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Valacyclovir

Celecoxib

Paxlovid

Placebo

Study Details

Brief summary:

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).

Conditions

Post-acute Sequelae of COVID-19

Long COVID

Study ID

NCT07597902

Start date

Oct 20, 2026

Status verified date

Aug, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Combination Drug Therapy

For 14 weeks, receives valacyclovir and celecoxib initially, then addition of Paxlovid for 25 days while decreasing valacyclovir dose, and then returns to valacyclovir at the original dose later.

placebo comparator: Placebo

For 14 weeks, receives matched placebo capsules and tablets

Interventions

Valacyclovir

one to two 750mg capsules taken orally in the morning and evening

Celecoxib

200mg capsules taken orally in the morning and evening

Paxlovid

one (100mg ritonavir tablet and two 150mg nirmatrelvir tablets) taken orally in the morning and evening

Placebo

matching placebo capsules and tablets taken orally in the morning and evening

Primary outcome measure

  • EQ-5D-5L Visual Analogue Scale (VAS) [ Time Frame: Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20 ]

Central Contacts and Locations

Central contacts

David Putrino, PhD

212-241-7658CoreResearch@mountsinai.org

Locations

The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)

Recruiting

New York, New York, United States, 10029

Contacts

CoreResearch@mountsinai.com

Principal Investigator:

David Putrino, PhD

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Oct 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-29. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-10-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.