SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction

NCT07597902 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: STUDY-25-00948
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20

Secondary Outcomes (8)

• The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L)

  Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20

• Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29)

  Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20

• General Symptom Questionnaire (GSQ-30)

  Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20

• Patient Health Questionnaire (PHQ-9)

  Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20

• Generalized Anxiety Disorder (GAD-7)

  Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20

Study Arms (2)

Combination Drug Therapy

EXPERIMENTAL

For 14 weeks, receives valacyclovir and celecoxib initially, then addition of Paxlovid for 15 days while decreasing valacyclovir dose, and then returns to valacyclovir at the original dose later.

Drug: Valacyclovir; Drug: Celecoxib; Drug: Paxlovid

Placebo

PLACEBO COMPARATOR

For 14 weeks, receives matched placebo capsules and tablets

Drug: Placebo

Interventions

Valacyclovir DRUG

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

Combination Drug Therapy

Celecoxib DRUG

200mg capsules taken orally in the morning and evening

Combination Drug Therapy

Paxlovid DRUG

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

Combination Drug Therapy

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

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

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Valacyclovir; Celecoxib; nirmatrelvir and ritonavir drug combination

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• David Putrino, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Putrino, PhD

CONTACT

212-241-7658; CoreResearch@mountsinai.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)