Protocol Valacyclovir Plus Celecoxib for Post-Acute Sequelae of SARS-CoV-2 (PASC) - Bateman Horne Center - RCT

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

A new RCT has been uploaded to clinicaltrials.gov.

The study is sponsored and led by the Bateman Horne Center under the leadership of Lucinda Bateman.

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.

Detailed Description:
This is a randomized, double-blinded, placebo-controlled, single-center, three arm, 12-week study designed to explore the safety and efficacy of daily doses of valacyclovir + celecoxib for the treatment of prolonged symptoms caused by COVID-19 infection in adult female patients. The treatment consists of twice daily doses of valacyclovir and celecoxib, which is theorized to provide potent suppression of tissue-resident herpes viruses subsequently activated by an initial infection with the SARS-CoV-2 virus. The physiological response to tissue-resident herpes virus activation is in turn hypothesized to be causally related to symptoms associated with the Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). There are three arms and in each arm, patients take four blue capsules and one white capsule in the morning and again in the evening. The capsules dispensed for arm 1 will consist of four 375mg valacyclovir capsules and one 200 mg celecoxib capsule. Arm 2 will be dispensed two blue 375mg valacyclovir capsules, two blue placebo capsules and one white 200 mg celecoxib capsule. Arm 3 will be dispensed four blue placebo capsules and one white placebo capsule.

Approximately 60 female patients will be enrolled at Bateman Horne Center for this study.

Candidates will undergo initial pre-screening by telephone or database review, after which, if they appear to meet initial entry criteria, they will have an in- person screening visit. They will start recording symptom data, starting at the baseline visit, and continuing with weekly recordings, for the duration of their study participation. Each week, the patient will provide information on their average fatigue, sleep quality and pain intensity.

Patients with underlying medical or psychiatric conditions that could impact their safe participation in the study or interfere with their ability to complete or comply with the study's requirements will not be enrolled. In addition, any patient dependent upon opioids/narcotics (collectively referred to as "opioids") for pain control for any reason will not be enrolled in the study.

Due to the celecoxib component of the combination therapy, patients using NSAIDs or COX-2 inhibitors will need to discontinue use of NSAIDs at least 7 days before randomization. NSAIDs including PRN usage should not be utilized for the duration of the study. Instead, acetaminophen may be utilized as needed throughout the study (but not to exceed 3250 mg per day). Patients may also continue low-dose aspirin for cardioprotection (< 325 mg/day).

Patients may remain on stable doses of SSRIs and other non-excluded anti- depressants; however, poorly controlled, or severely depressed patients should not be enrolled. Only clinically stable and well-controlled patients should be considered, i.e., patients with mild to moderate depression who in the judgement of the investigator are not at risk of suicidal ideation or behavior.

For all patients a screening visit will be conducted so the PI or Sub-I can ensure that all entry criteria have been satisfied. At baseline, the PI/sub-I will ensure all safety laboratory results are satisfactory, any required washout has been completed and all entry criteria have been met. Patients should initiate study drug treatment on the day of the Baseline visit (Day 1), followed by BID dosing for the duration of the study.

Blood and urine will be collected at the Screening visit for safety assessments. Urine pregnancy tests will be performed at Week 4, 8 and 12 (or early termination) visits for patients with child-bearing potential. A blood sample for safety labs will be collected during Week 12/ET. Urine drug screening for drugs of abuse will be conducted at the Screening visit; patients positive for cocaine, methamphetamine, phencyclidine (PCP), methadone, non-disclosed amphetamines and non-disclosed opiates will be screen failed. Patients positive for disclosed, prescribed opioids at the Screening visit, yet deemed suitable for washout, must be able to remain off all opioids for the duration of the study and have a negative repeat UDS at the Baseline visit. Additional drug testing may be conducted at the PI or Sub-I's discretion.

Patients with clinically significant renal insufficiency or a history of renal disease (as defined in the entry criteria) will be excluded.

Patients will have in-person study visits scheduled for Screening, Baseline, Weeks 4, 8 and 12/ET. If necessary, remote visits may be substituted for the Week 4 and/or Week 8 visits. A follow-up survey or phone call will be scheduled approximately 2 weeks after completion of study drug treatment at Week 12 or ET.

Primary Outcome Measures :
Fatigue assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Instrument [ Time Frame: 12 weeks ]

Most relevant inclusion criteria:

• Female at birth, 18-65 years of age at the time of study entry.
• 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.

An ME/CFS diagnosis prior to January 2020 is an exclusion criteria.

https://classic.clinicaltrials.gov/...erm=Valacyclovir+Plus+Celecoxib&draw=2&rank=1

 

If the basis for this trial is supression of tissue-resident herpes viruses activated by an initial infection with the SARS-CoV-2 virus, I do wonder why something like glandular fever after a SARS-COV-2 infection isn't part of the recruitment criteria. Perhaps it would have made recruitment too difficult?

 

I don't understand why there is no stratification to valacyclovir without celecoxib and vice versa. Any positive result can be ascribed to just taking celecoxib (controls not even being allowed to use another NSAID).

 

Valacyclovir + celecoxib has been discussed on the thread "Virios Therapeutics - biotech company with anti-viral therapies for post-infection syndromes" where @Hutan already made remarks on possible problems with blinding, as well as a need for trial arms where each drug is trialled alone.

 

The viral theory is like a zombie: it keeps coming back despite the repeated failures. As persistent as the virus that the theory posits. No idea why Bateman Center is wasting time on this, even if the drug company is paying for it. Because LC is different from ME/CFS?