Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316843
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-11
Brief Title:
Valacyclovir Plus Celecoxib for Post-Acute Sequelae of SARS-CoV-2
Sponsor:
Bateman Horne Center
Organization:
Bateman Horne Center
Study Overview
Official Title:
A Randomized Double-Blinded Placebo-Controlled Pilot Study of the Combination of Valacyclovir Celecoxib IMC-2 for the Treatment of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PASC
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 studys requirements will not be enrolled In addition any patient dependent upon opioidsnarcotics 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 mgday
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 ie 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 PIsub-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 12ET 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-Is 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 12ET If necessary remote visits may be substituted for the Week 4 andor 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
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 studys requirements will not be enrolled In addition any patient dependent upon opioidsnarcotics 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 mgday
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 ie 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 PIsub-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 12ET 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-Is 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 12ET If necessary remote visits may be substituted for the Week 4 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None