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)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Number of Participants That Had Any Confusion Over How to Take the Study Drug, Including Which Pill to Take, When to Take it, or How Many to Take
研究概览
简要总结
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 and/or medical records from a healthcare provider that coincides with the diagnosis of long-COVID.
详细描述
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) 2.0, 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 (i.e., Day -28- Day -22).
Subjects who complete the screening phase will proceed to randomization where they will be randomized 2:1 to either histamine receptor antagonists (cetirizine and famotidine) or matching placebos. Emory University's 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years of age with a history of a SARS-CoV-2 PCR positive test and/or medical records from a healthcare provider that coincides with the diagnosis of long-COVID
- •New or worsened symptoms since the onset of COVID-19 that are persistent at the time of enrollment and have lasted for ≥ 12 weeks (including at least one of the following: fatigue, post-exertional malaise (PEM), headache, brain fog, sleep disturbance, dysautonomia.
- •Confirmation of negative urine or serum human chorionic gonadotropin (HCG) (pregnancy) test in women of childbearing potential
- •Willing to use appropriate contraceptives for female and male subjects for the duration of the study
- •Has an address (for mailing of study drug) in the state of Georgia
- •Able to swallow capsules
- •Has reliable access to a mobile phone, tablet, laptop, or desktop computer capable of connecting to the internet via Wi-Fi or a data plan
- •Available lab work (CBC and CMP) after the onset of long COVID symptoms
- •Willing and able to comply with scheduled visits, treatment plan, and other study procedures including receiving either intervention or placebo
- •Willing to not take any of the study medications while enrolled in the study except for essential needs as prescribed by a healthcare provider
排除标准
- •No post-acute COVID-19 symptoms (PASC) symptoms at the time of enrollment or PASC symptoms present <12 weeks at the time of enrollment
- •Inability to provide own informed consent
- •Currently Hospitalized
- •For women of childbearing potential (WOCBP), currently pregnant or plans to become pregnant during the study period; for males with partners of childbearing potential (OCBP), plans to become pregnant during the study period
- •Actively enrolled in another Long COVID/PASC interventional trial or participation in another interventional clinical trial in the last 30 days or planned during the trial period
- •Unstable medical comorbidities (e.g., decompensated cirrhosis, stage III-IV chronic kidney disease, New York Heart Association (NYHA) class III congestive heart failure), per the patient report, telemedicine physical exam, baseline laboratory values (hematology and extended chemistry panels) and/or medical records
- •Other medical conditions occurring after the onset of COVID-19 that can otherwise account for PASC-type symptoms
- •Currently immunocompromised from the following: solid organ transplant, bone marrow transplant (BMT), high dose steroids (>20mg prednisone per day), immune modulators, or chemotherapy
- •Currently taking opioid analgesics, undergoing treatment for opioid addiction, or taking any other prohibited concomitant medication
- •Opioid dependence or withdrawal syndrome
- •Known sensitivity or adverse reaction to H1 or H2 receptor antagonists, or medication components
- •Suspected or confirmed pregnancy or breastfeeding
- •Participants already on H1 or H2 receptor antagonists within three (3) months of randomization
- •Currently receiving other therapies to treat COVID-19 or Long COVID symptoms, e.g., convalescent plasma, remdesivir, Paxlovid
研究组 & 干预措施
HRA Treatment Arm
Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily.
干预措施: Cetirizine (Drug)
HRA Treatment Arm
Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily.
干预措施: Famotidine (Drug)
Placebo Arm
The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration.
干预措施: Cetirizine Placebo (Drug)
Placebo Arm
The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration.
干预措施: Famotidine Placebo (Drug)
结局指标
主要结局
Number of Participants That Had Any Confusion Over How to Take the Study Drug, Including Which Pill to Take, When to Take it, or How Many to Take
时间窗: End of the Treatment Phase at 12 weeks
The number of participants that had any confusion over how to take the study drug, including which pill to take, when to take it, or how many to take will be recorded as part of the end-of-study survey.
Number of Participants That Felt They Could Reach Study Staff if Needed
时间窗: End of the Treatment Phase at 12 weeks
The number of participants that felt they could reach study staff if needed will be recorded as part of the end-of-study survey.
Number of Participants That Felt That the Amount of Information Collected in Each Series of Surveys Was Acceptable
时间窗: End of the Treatment Phase at 12 weeks
The number of participants that felt that the amount of information collected in each series of surveys was acceptable will be recorded as part of the end-of-study survey.
Number of Participants That Felt That the Frequency in Which the Information Was Collected Was Acceptable
时间窗: End of the Treatment Phase at 12 weeks
The number of participants that felt that the frequency in which the information was collected was acceptable will be recorded as part of the end-of-study survey.
Improvement Rating
时间窗: End of the Treatment Phase at 12 weeks
Participants will be asked how much they feel they improved from this treatment over the last 12 week using a scale from 1 to 5, with 5 being complete improvement (better outcome) and 1 being no improvement.
Number of Participants That Had Trouble Adhering to the Study Drug Schedule
时间窗: End of the Treatment Phase at 12 weeks
The number of participants that had trouble adhering to the study drug schedule will be recorded as part of the end-of-study survey.
Number of Participants Satisfied With Their Opportunities to Interact With Study Staff
时间窗: End of the Treatment Phase at 12 weeks
The number of participants satisfied with their opportunities to interact with study staff will be recorded as part of the end-of-study survey.
Number of Participants That Had Any Difficulty Using the REDCap Interface.
时间窗: End of the Treatment Phase at 12 weeks
The number of participants that had any difficulty using the REDCap interface will be recorded as part of the end-of-study survey.
Number of Participants That Prefer Participating in This Virtual Study
时间窗: End of the Treatment Phase at 12 weeks
The number of participants that prefer participating in this virtual study compared to participating in an in-person study hosted at a medical center will be recorded as part of the end-of-study survey.
Number of Participants That Felt That Study Staff Was Available and Easy to Contact to Report Any Adverse Effects
时间窗: End of the Treatment Phase at 12 weeks
The number of participants that felt that study staff was available and easy to contact to report any adverse effects that they experienced from the medication will be recorded as part of the end-of-study survey.
Quality of Life (QoL) Score Rating
时间窗: End of the Treatment Phase at 12 weeks
Participants will be asked how much their quality of life was impacted by changes to their health during the study. On a scale of 1 to 5 with 5 being the most impacted (better outcome) and 1 being not at all impacted by changes to their health.
Interest Score
时间窗: End of the Treatment Phase at 12 weeks
Participants will be asked how interested they are in continuing treatment with the study medication after the study. On a scale of 1 to 5, with 5 being completely interested (better outcome) and 1 being completely uninterested.
次要结局
- Proportion of Survey Completion(End of the Treatment Phase at 12 weeks)
- Proportion of Study Drug Adherence(End of the Treatment Phase at 12 weeks)
- Proportion of Lost to Follow Up (LFUP)(End of the Treatment Phase at 12 weeks)
- Proportion of Voluntary Termination(End of the Treatment Phase at 12 weeks)
- Adverse Events (AEs) Incidence(End of the Treatment Phase at 12 weeks)
- Serious, Unexpected Suspected Adverse Reactions (SUSAR) Incidence(End of the Treatment Phase at 12 weeks)
- Study-wide Serious Adverse Events (SAEs) Incidence(End of the Treatment Phase at 12 weeks)
- Number of Discontinuations or Temporary Suspensions of IP(End of the Treatment Phase at 12 weeks)
研究者
Tiffany A Walker
Assistant Professor
Emory University