Valacyclovir Plus Celecoxib for Post-Acute Sequelae of SARS-CoV-2

NCT06316843 | Completed Phase 2 FDA Drug

• 1 other identifier: BHC202 v2.1
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the safety and efficacy of daily doses of celecoxib + valacyclovir in the treatment of patients with prolonged symptoms caused by COVID-19.

Conditions

Long COVID; PASC Post Acute Sequelae of COVID 19

Outcome Measures

Primary Outcomes (1)

• Fatigue assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Instrument

  The PROMIS Fatigue 7a will be automatically calculated to a T-score with a standard error of 4. Higher fatigue T-scores represent worse than average fatigue. The primary efficacy analysis will be the mean change from baseline (MCFB) to Week 12 in fatigue based on the weekly survey PROMIS Fatigue 7a T-scores. A mixed models for repeated measures (MMRM) procedure will be used to compare the MCFB between the treatment and placebo arm.

  12 weeks

Study Arms (3)

1500 Valacyclovir 200 Celecoxib

EXPERIMENTAL

Treatment will consist of four blue 375mg valacyclovir capsules and one white 200 mg celecoxib capsule

Drug: Valacyclovir celecoxib dose 1

750 Valacyclovir 200 Celecoxib

EXPERIMENTAL

Treatment will consist of two blue 375mg valacyclovir capsules, two blue placebo capsules, and one white 200 mg celecoxib capsule

Drug: Valacyclovir celecoxib dose 2

Matched Color Placebo Capsules

PLACEBO COMPARATOR

Treatment will consist of four blue placebo capsules and one white placebo capsule

Drug: Placebo

Interventions

Valacyclovir celecoxib dose 1 DRUG

1500 mg valacyclovir 200 mg celecoxib taken two times a day

Also known as: Arm 1

1500 Valacyclovir 200 Celecoxib

Valacyclovir celecoxib dose 2 DRUG

750 mg valacyclovir 200 celecoxib mg taken two times a day

Also known as: Arm 2

750 Valacyclovir 200 Celecoxib

Placebo DRUG

Placebo capsules colored matched to investigational product taken two times a day

Also known as: Arm 3

Matched Color Placebo Capsules

Eligibility Criteria

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

You may qualify if:

• Willing and able to read, understand, and sign the informed consent.
• Female at birth, 18-65 years of age at the time of study entry.
• Must have smartphone with internet access to complete surveys online.
• Diagnosis of Long COVID according to any of the following definitions Infected individuals will have a history of suspected, probable, or confirmed SARS-CoV-2 infection as defined by WHO criteria and at least three months of persistent fatigue and muscle weakness, functional impairment, and cognitive impairment since the acute infection.
• Adults with suspected SARS-CoV-2 infection. An adult qualifies as having suspected SARS-CoV-2 infection if meeting at least one of the following criteria (a-e) below:
• a. Clinical criteria: Acute onset of fever and cough OR acute onset of any three or more of the following signs or symptoms: fever, cough, general weakness /fatigue, headache, myalgia, sore throat, coryza, dyspnea, anorexia/nausea/vomiting, diarrhea, altered mental status. These patients should also meet one of the following epidemiological criteria: i. Epidemiological criteria:
• Residing or working in an area with a high risk of transmission of virus: closed residential settings, humanitarian settings such as camp and camp-like settings for displaced persons; anytime within the 14 days before symptom onset; or
• Residing or travel to an area with community transmission anytime within the 14 days before symptom onset; or
• Working in any health care setting, including within health facilities or the community, anytime within the 14 days before symptom onset.
• b. A patient with severe acute respiratory illness: (acute respiratory infection with history of fever or measured fever of ≥38C°; and cough; with onset within the last ten days; and requires hospitalization).
• c. An asymptomatic patient not meeting any of the epidemiologic criteria above but with a previously positive SARS-CoV-2 Antigen- RDT.
• d. Adults with probable SARS-CoV-2 infection. An adult qualifies as having probable SARS-CoV-2 infection if meeting any one of 1-3 below: i. A patient who meets clinical criteria for suspected SARS- CoV-2 AND is a contact of a probable or confirmed case or linked to a COVID-19 cluster; ii. A suspect case with chest imaging showing findings suggestive of COVID-19 disease; iii. A person with recent onset of anosmia (loss of smell) or ageusia (loss of taste) in the absence of any other identified cause; e. Adults with confirmed SARS-CoV-2 infection. An adult qualifies as having confirmed SARS-CoV-2 infection if meeting any one of 1-4 below: i. Any person with a positive Nucleic Acid Amplification Test (NAAT); ii. Any person with of a positive SARS-CoV-2 Antigen-RDT AND meeting either the probable case definition or suspect criteria A OR B; iii. An asymptomatic person with a positive SARS-CoV-2 Antigen-RDT who is a contact of a probable or confirmed case; iv. Any person with a positive SARS-CoV-2 nucleocapsid protein antibody test OR a positive SARS-CoV-2 spike protein antibody test IF not vaccinated
• \. Women 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. Women confirmed to be of non-childbearing potential do not require pregnancy testing. Pregnancy tests will not be required for remote visits. To be considered of non-child-bearing potential, the patient must be:
• a. Post-menopausal (defined as no menses for at least one year); or b. Surgically sterile (s/p hysterectomy, bilateral oophorectomy, or bilateral tubal ligation at least six months prior to beginning treatment with study drug); or c. At least three months s/p a non-surgical permanent sterilization procedure 6. 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. The following stipulations also apply:
• Patients with a positive screening UDS due to prescribed amphetamines for allowed conditions do not require further UDS testing. They may proceed with study treatment, assuming no evidence of abuse or dependency.

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 patient's ability to participate in the study or potentially compromise her 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.
• A score of \>15 on the Patient Health Questionnaire-9 (PHQ-9) determined by survey at screening.
• A positive response to thoughts of suicide or self-harm on the PHQ-9 determined by survey at screening.
• A diagnosis of ME/CFS prior to January 2020.
• Any anticipated need for surgery that in the opinion of the Principal Investigator or Sub-I might confound results or interfere with the patient's ability to comply with the protocol.
• Symptomatic and/or otherwise clinically significant cardiac disease, including but not limited to myocardial infarction during the preceding two years; uncontrolled hypertension; symptomatic heart failure (e.g., New York Heart Association Class II or higher); angina or other evidence of significant coronary artery disease; clinically significant cardiac rhythm or conduction abnormality or anticipation of bypass or other cardiac surgery within the next 12 months.
• 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. (Patient may remain in screening until the active infection has resolved, or re-screen after recuperation.)
• Currently receiving chronic systemic corticosteroids (\>5 mg prednisone daily, or equivalent).
• Uncontrolled sleep apnea. Patients successfully treated with CPAP or other devices are eligible.
• 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 patient has undergone a malabsorptive weight loss procedure (e.g., Roux-en-Y or other bypass procedure).

Sponsors & Collaborators

• Bateman Horne Center: lead

Study Sites (1)

Bateman Horne Center

Salt Lake City, Utah, 84102, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

DMAC2L protein, human

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

Study Officials

• Lucinda Bateman, MD

  Bateman Horne Center

  PRINCIPAL INVESTIGATOR

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: Medical Director

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 19, 2024
• Study Start: October 15, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: January 22, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)