Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05946551
Status:
TERMINATED
Last Update Posted:
2024-06-24
First Post:
2023-07-12
Brief Title:
Treatment of Long CoronaVirus Disease COVID TLC Feasibility Trial
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Feasibility Assessment of a Decentralized Platform Adaptive Double-Blind Randomized Controlled Trial Investigating Repurposed Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 PASC
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to assess the feasibility and acceptability of methods and procedures to be employed in a larger scale decentralized platform adaptive randomized clinical trial in patients with a history of a Severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 Polymerase Chain Reaction PCR positive test andor medical records from a healthcare provider that coincides with the diagnosis of long-COVID
Detailed Description:
Fully decentralized single-center double-blind randomized placebo-controlled pilot feasibility trial for patients reporting symptoms consistent with at least one of the following PASC symptoms Brain fog Fatigue Headache Sleep Disturbance Post-exertional Malaise PEM or Dysautonomia
Participants interactions with study staff and the study visits will occur primarily via REDCap and Zoom Informed consent will be conducted remotely via Zoom and obtained electronically in REDCap Subjects will complete protocol-required logs questionnaires and surveys in REDCap Dose tolerability assessments will occur via televisit preferably or phone if necessary
Following informed consent subjects will enter a 4-week screening period during which medical records will be obtained and reviewed At baseline Day -28 subjects will complete a battery of tests consisting of the World Health Organization Disability Assessment Schedule WHODAS 20 Patient Reported Outcomes Measurement Information System PROMIS Fatigue 7a Insomnia Severity Scale PROMIS Cognitive Function 6A DePaul Symptom Questionnaire - Post-Exertional Malaise DSQ-PEM Short Form Headache Diary COMPASS 31 and Self-reported persistent symptoms questionnaire The headache diary requires daily tracking for 7 days ie Day -28- Day -22
Subjects who complete the screening phase will proceed to randomization where they will be randomized 21 to either histamine receptor antagonists cetirizine and famotidine or matching placebos Emory Universitys Investigational Drug Services IDS will conduct the randomization and will overnight via national courier the assigned medication to the study subject The treatment phase of 12 weeks starts upon ingestion of the first dose
Cetirizine and famotidine will be supplied as 10mg capsules and 20mg capsules respectively Dosing for the entire treatment period is one 10mg capsule cetirizine or placebo once daily preferably at bedtime and one 20mg capsule famotidine or placebo twice daily as near as possible to the same time every day Dose tolerability will be assessed on Day 14 via televisit or phone call If the dose of either IP is not tolerated subjects will be removed from the study If the doses are tolerated subjects will be resupplied and tolerability assessed per protocol
Throughout the treatment phase subjects in all arms will complete the symptom questionnaire adverse event study drug adherence and concomitant medication logs weekly All subjects will complete the full battery of tests on Days 42 63 and 84 Weeks 6 9 and 12 Subjects will have a - 3-day window in which to complete the battery However the headache diary requires daily tracking for the 7 days preceding Days 43 63 and 84 On Day 84 all subjects will complete an end-of-study survey assessing their thoughts and feelings about the study methods and procedures
Participants interactions with study staff and the study visits will occur primarily via REDCap and Zoom Informed consent will be conducted remotely via Zoom and obtained electronically in REDCap Subjects will complete protocol-required logs questionnaires and surveys in REDCap Dose tolerability assessments will occur via televisit preferably or phone if necessary
Following informed consent subjects will enter a 4-week screening period during which medical records will be obtained and reviewed At baseline Day -28 subjects will complete a battery of tests consisting of the World Health Organization Disability Assessment Schedule WHODAS 20 Patient Reported Outcomes Measurement Information System PROMIS Fatigue 7a Insomnia Severity Scale PROMIS Cognitive Function 6A DePaul Symptom Questionnaire - Post-Exertional Malaise DSQ-PEM Short Form Headache Diary COMPASS 31 and Self-reported persistent symptoms questionnaire The headache diary requires daily tracking for 7 days ie Day -28- Day -22
Subjects who complete the screening phase will proceed to randomization where they will be randomized 21 to either histamine receptor antagonists cetirizine and famotidine or matching placebos Emory Universitys Investigational Drug Services IDS will conduct the randomization and will overnight via national courier the assigned medication to the study subject The treatment phase of 12 weeks starts upon ingestion of the first dose
Cetirizine and famotidine will be supplied as 10mg capsules and 20mg capsules respectively Dosing for the entire treatment period is one 10mg capsule cetirizine or placebo once daily preferably at bedtime and one 20mg capsule famotidine or placebo twice daily as near as possible to the same time every day Dose tolerability will be assessed on Day 14 via televisit or phone call If the dose of either IP is not tolerated subjects will be removed from the study If the doses are tolerated subjects will be resupplied and tolerability assessed per protocol
Throughout the treatment phase subjects in all arms will complete the symptom questionnaire adverse event study drug adherence and concomitant medication logs weekly All subjects will complete the full battery of tests on Days 42 63 and 84 Weeks 6 9 and 12 Subjects will have a - 3-day window in which to complete the battery However the headache diary requires daily tracking for the 7 days preceding Days 43 63 and 84 On Day 84 all subjects will complete an end-of-study survey assessing their thoughts and feelings about the study methods and procedures
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?:
None
Is an FDA AA801 Violation?:
None