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)
Phase: PHASE3
Conditions: COVID-19
Sponsor: Emory University

 
 
 
 
 
 
 
 
Treatment of Long CoronaVirus Disease (COVID) (TLC) Feasibility Trial 
NCT05946551 
 
 
Date: November 20, 2023 
STUDY00005537 

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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Version: 2.0_20Nov 2023
IRB Form BIO 01192022
PROTOCOL TITLE:   Treatment of Long COVID (TLC) Feasibility Trial: 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)
EXTERNAL (NON-EMORY) COLLABORATORS                                                                   
Critical Path Institute (C-Path)—Will complete an IAA
LEAD CLINICAL RESEARCH COORDINATOR:
Name: 
 MS, CCRP
Department: Critical Path Institute—CURE Drug Repurposing Collaboratory
Telephone Number: 
  
Email Address: 
 
PRINCIPAL INVESTIGATOR:
Name: 
, MD
Department: Emory University School of Medicine
Telephone Number: 
  
Email Address: 
VERSION: 2.0
FUNDING SOURCE: This study is funded by the Office of the Assistant Secretary for Planning 
and Evaluation (ASPE) (Prime Grant Number: 2U18FD005320) and Emory University.  

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
Page 1 of 49
 
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IRB Form BIO 01192022
REVISION HISTORY
 
Revision #
Version 
Date
Summary of Changes
1
2.0
20_NOV_20
23

Removal of Low Dose Naltrexone (LDN) arm from 
protocol

Change of randomization to blinded 2:1 IP : 
placebos

Increase stipend from $25.00 to $50.00 for 
screening; revise total possible compensation to 
$200.00

Revision of IP shipping schedule to initial supply of 
28 days' shipped overnight on Day 0 followed by 
remaining 56 days' supply with standard shipping 
mailed after Day 14 dose tolerance assessment. 

Revision of Study Schema to reflect deletion of LDN 
arm

Moved timing of question regarding subject’s most 
burdensome PASC symptom from Section 12 
Population to Section 6.5.2 Randomization/Day 0

Updated Schedule of Events to reflect protocol 
changes

Minor grammatical and formatting corrections

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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IRB Form BIO 01192022
Table of Contents
1.
Study Summary....................................................................................................................4
2.
Objectives ............................................................................................................................5
3.
Background..........................................................................................................................5
4.
Study Endpoints...................................................................................................................7
5.
Study Intervention/Investigational Agent ...........................................................................8
6.
Procedures Involved ..........................................................................................................11
7.
Statistical Analysis Plan......................................................................................................15
8.
Data and/or Specimen Banking .........................................................................................17
9.
Sharing of Results with Participants ..................................................................................17
10.
Study Timelines..................................................................................................................18
11.
Inclusion and Exclusion Criteria.........................................................................................18
12.
Population .........................................................................................................................20
13.
Vulnerable Populations .....................................................................................................21
14.
Local Number of Participants ............................................................................................21
15.
Recruitment Methods........................................................................................................21
16.
Withdrawal of Participants................................................................................................22
17.
Risk to Participants ............................................................................................................23
18.
Potential Benefits to Participants......................................................................................24
19.
Compensation to Participants ...........................................................................................24
20.
Data Management and Confidentiality .............................................................................25
21.
Plans to Monitor the Data to Ensure Safety of Participants and Data Integrity................27
22.
Provisions to Protect the Privacy Interest of Participants .................................................30
23.
Economic Burden to Participants ......................................................................................31
24.
Informed Consent..............................................................................................................31
25.
Setting................................................................................................................................32
26.
Resources Available...........................................................................................................32
27.
References.........................................................................................................................32
28.
Protocol Checklist ..............................................................................................................35

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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1. Study Summary
Project Title
Treatment of Long COVID (TLC) Feasibility Trial: Feasibility 
Assessment of a Decentralized Platform Double-Blind, Randomized 
Controlled Trial Investigating Repurposed Drugs in the Treatment of 
Post-Acute Sequelae of Coronavirus-19 (PASC)
Project Design
Fully decentralized single center, double-blind, randomized, 
placebo-controlled pilot feasibility trial 
Primary Objective
Assess the feasibility and acceptability of methods and procedures, 
as determined by subjects, to be employed in a larger scale 
decentralized platform adaptive randomization clinical trial.
Secondary Objective(s)

Completion rate of quality of life assessments

Adherence to Investigational Product

Attrition rates

Safety
Exploratory Objectives

Efficacy
Research 
Intervention(s)/Interactions

Cetirizine

Famotidine
Study Population
Adults ≥18 years of age with new or worsened symptoms since 
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). All subjects will be Georgia residents.
Sample Size
Up to 36
Study Duration for 
individual participants
16 weeks (4 weeks Screening, 12 weeks Treatment)
Study Specific 
Abbreviations/ Definitions 
AE
Adverse event
COVID-19
Disease caused by SARS-COV-2
CRC
Clinical Research Coordinator
EMR
Electronic Medical Record
GAD-7
Generalized Anxiety Disorder 7-question Survey
HRA
Histamine Receptor Antagonist
IP
Investigational product
ITT
Intent-to-treat
ME/CFS
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
MFIS
Modified Fatigue Impact Scale
PASC
Post-acute Sequelae of SARS-CoV-2

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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PHQ-8
Patient Health Questionnaire 8-question survey
POTS
Postural Orthostatic Tachycardia Syndrome
PP
Per protocol
PROMIS 
Patient Reported Outcome Measurement Information System
RC
Research coordinator
WHODAS
Mean WHO Disability Assessment Schedule
Funding Source (if any)
Office of the Assistant Secretary for Planning and Evaluation (ASPE) 
and Emory University.
2. Objectives
Primary Objective: The primary objective is to assess the feasibility and acceptability of 
methods and procedures, as determined by subjects, to be employed in a larger scale 
decentralized platform adaptive randomized clinical trial.
Secondary Objectives: Secondary objectives are to assess completion rate of quality of life 
assessments, adherence to Investigational Product, attrition rates and safety.
Exploratory Objective: The exploratory objective is to assess efficacy of histamine receptor 
antagonist (HRA) therapy in improving outcomes in patients with Post-Acute Sequelae of 
Coronavirus-19 (PASC) and at least one of the following symptoms: fatigue, post-exertional 
malaise (PEM), headache, brain fog, sleep disturbance, dysautonomia.
3. Background
In December 2019, a new human coronavirus with respiratory tropism, SARS-CoV-2, 
emerged in China and rapidly spread to other parts of the world [6, 7]. The coronavirus 
disease 2019 (COVID-19) has resulted in over 100 million confirmed cases of infection [8]. 
Although there are numerous publications describing the wide range of acute phase 
manifestations, there remains limited data on long-term sequelae of COVID-19, aka Post-
Acute Sequelae of SARS-CoV-2 (PASC) or “Long COVID”. PASC may occur in 20-30% of 
COVID-19 patients, and symptoms result in significant impairments in quality of life [9-18]. 
With the growing prevalence of COVID-19, PASC is creating a substantial global burden [19]. 
Though common complaints include dyspnea, fatigue, brain fog, weakness, pain syndromes, 
anxiety, and depression, PASC can manifest as a myriad of symptoms [10, 11, 13]. In many, 
these symptoms can persist for >6 months, and the true duration of this disease remains 
unclear [13].  
Though the underlying pathophysiology of PASC symptoms remains unknown, several 
mechanisms have been proposed in individuals with no detectable parenchymal or 
structural damage resulting from acute COVID-19 infection. SARS-CoV-2 can persist in bodily 

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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fluids for a prolonged period extending beyond the acute viral phase, but little is known 
about the clinical relevance of this finding [20,21]. Concern exists that persistent viral 
reservoirs remain undetected, promoting ongoing, heightened immune responses 
contributing to the myriad of symptoms seen in PASC [22]. Furthermore, natural killer (NK) 
cells appear to play an important role in the innate immune response to COVID-19, wherein 
diminished NK cell response is associated with viral persistence and increased mortality 
[23]. Reduction in NK cell number and function occurring in COVID-19, particularly severe 
infections, results in decreased clearance of infected cells and unchecked elevation of 
tissue-damaging inflammation markers. SARS-CoV-2 infection skews the immune response 
towards an overwhelmingly inflammatory phenotype. Restoration of NK cell effector 
function has the potential to correct the delicate immune balance required to effectively 
overcome SARS-CoV-2 infection [24]. Others suggest that PASC is mediated through non-
viral inflammatory mechanisms, such as mast cell activation syndrome (MCAS), which may 
explain the inflammatory, multisystem nature of PASC symptoms [25]. Here it is posited 
that a dysfunctional population of mast cells become hyper-stimulated in a continuous 
activation loop, leading to the heterogeneous clinical presentations seen in PASC patients. 
Also proposed is an autoimmune link, wherein hosts lose tolerance to auto antigens due to 
molecular mimicry between pathogen and host proteins leading to dysregulated immune 
response. Autoantibodies opposing B cells, various cytokines, and cellular membrane 
components have been identified in patients with severe acute COVID-19, though studies 
demonstrating this processing in PASC remain sparse [26-28]. 
A host of medications have been investigated in the treatment of acute COVID-19, though 
few drugs have been studied in formal randomized controlled trials in the post-acute phase 
to address persistent symptoms and long-term sequelae. A panel assembled by the CURE 
Drug Repurposing Collaboratory (CDRC) – a public-private partnership - that includes at 
least one of each of the following—physician, pharmaceutical engineer, pharmacist, public 
health professional, immunologist, patient, and drug repurposing expert—reviewed the 
available data for over 60 candidate therapeutic approaches. Several drugs appeared to be 
promising based on early anecdotal reports and plausible mechanisms. Given the urgency of 
finding answers and the need for randomized controlled trials to begin to determine drugs 
that are effective for PASC, the panel selected the following treatment as an initial 
approach. 
As mast cell activation syndrome is one theorized mechanism of severe acute COVID-19 and 
a proposed physiologic derangement contributing to PASC, histamine receptor antagonists 
(HRA), such as famotidine and cetirizine, have garnered interest as possible drug 
candidates. (See section 5.1.2). These agents may modulate their effects through reductions 
in cellular inflammatory mediators, such as histamine, serotonin, TGFb, VEGF, IL6, IL8, 

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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interferons, and NETs and modulation of dysregulated T cells. Administration of HRAs in a 
relatively small cohort of PASC patients (N=25) demonstrated a 72% improvement in patient 
reported symptoms, of which, 20% had complete symptom resolution [34]. This is 
compared with those who received no treatment (N=40) who experienced a 50% 
improvement, with complete resolution in 4% in the same period. 
4. Study Endpoints
Primary endpoint: 

Subject reported (patient reported outcome [PRO]) end of study questionnare
Secondary endpoints: 

% subjects who complete 70% of PRO surveys/questionnaires at 12 weeks

% subjects who complete 70% of IP doses through 12 weeks

% subjects Lost to Follow Up (LTFU) 

% subjects voluntarily terminate participation

Incidence of adverse events and serious adverse events

Number of discontinuations or temporary suspensions of IP 
5. Study Intervention/Investigational Agent 
5.1 Cetirizine 
Cetirizine is a histamine receptor antagonist (HRA). It will be dispensed as a 10mg 
capsule with instructions for subjects to take one capsule daily by mouth. Subjects will 
be instructed to take the IP as close to the same time every day as possible, preferably 
at bedtime. 
5.2 Famotidine
Famotidine is a histamine receptor antagonist (HRA). It will be dispensed in 20mg 
capsules with instructions for subjects to take one capsule twice daily, as close to the 
same time every day as possible. 
5.4 Pharmacokinetics 
5.4.1 Cetirizine
Cetirizine hydrochloride is a second-generation antihistamine that selectively 
antagonizes peripheral histamine (H1) receptors [34]. Glomerular filtration is the 
predominant mode of renal elimination for the predominately unmetabolized 
drug, which has minimal liver metabolism or CYP450 interaction. The half-life is 

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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IRB Form BIO 01192022
8.3 hours with preserved renal function and 24.9 hours with moderate to severe 
renal impairment. 
5.4.2 Famotidine
Famotidine hydrochloride selectively antagonizes peripheral histamine (H2) 
receptors [33]. Glomerular filtration is the predominant mode of renal 
elimination for the predominately unmetabolized drug, which has minimal liver 
metabolism or CYP450 interaction. The half-life is 2.5 hours with preserved renal 
function and 20 hours with severe renal impairment. 
5.5 Placebo
The investigational pharmacy will provide placebo capsules manufactured to match 
each study treatment for oral administration. 
The HRA placebos will be designed as capsules of the inert substance microcrystalline 
cellulose and will match the morphology of the respective HRA treatment capsules. 
5.6 Storage and Stability
All IP will be stored at USP controlled room temperature 20°-25° (68°-77 °F). Excursions 
between 15° and 30° (59° and 86 °F) that are experienced in pharmacies, hospitals, and 
warehouses, and during shipping are allowed. Provided the mean kinetic temperature 
does not exceed 25°, transient spikes up to 40° are permitted as long as they do not 
exceed 24 h. Participants will be instructed to maintain their IP under these conditions. 
IPs will be maintained in a tight, child-proof container.
Control of the IPs used in this protocol will be accomplished by following the 
established, approved organizational SOPs of the Emory Investigational Drug Service 
(IDS) regarding protocol management and IP accountability, IP storage, temperature 
monitoring, randomization by unblinded pharmacists, dose preparation, IP labeling, and 
shipping of study medication to subjects. 
5.7 IND
Dr.
 holds the IND #162060 and is acting as the Sponsor-Investigator for 
this study.

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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5.8 Provision of Investigational Product to Participants
Following receipt of confirmed subject eligibility and consent, IDS will randomize 
subjects as described below in Section 6.1. IDS will prepare the courier or overnight mail 
service, which will deliver IP to participants according to the below dosing schedule. 
Clear instructions will be provided to the subject regarding the number and type of 
capsules to be ingested at each IP administration time point listed.
  
5.9 Acquisition 
A sufficient quantity of the FDA-approved or compounded formulation of famotidine, 
cetirizine and placebo for the study will be purchased and distributed by the Emory 
Investigational Drug Services (IDS). Emory IDS was chosen because of its experience in 
the compounding of medications for clinical trials, available formulations and strengths, 
assays for potency, and ability to provide matched placebos. 

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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5.10 Accountability and Destruction Procedures 
Subjects will not be required to return any excess drug capsules to the facility. Subjects 
will dispose of excess drug capsules locally, ensuring that the child-protection closure 
system is intact.
5.11 Treatment Adherence
Treatment adherence will be measured by subjects completing a weekly assessment of 
their IP adherence by completing a study adherence log. The CRC will also review 
remaining pill count with the subject during study visits to inform adherence.
6. Procedures Involved
6.1 Study Design
This is a fully decentralized, single center, randomized, double-blind, placebo controlled, 
clinical trial to evaluate the safety, tolerability, and feasibility of a potential treatment 
for PASC. 
Upon confirmation of eligibility, the investigational pharmacist will randomize subjects 
2:1 treatment versus placebo.  Treatment consists of 10mg of cetirizine daily and 20mg 
of famotidine twice daily. Placebos will match the morphology of the treatments but 
contain no active ingredients. Study subject and study team will be blind to assigned 
treatment; only the IDS will be unblind. 
Subjects will be followed for safety, tolerability, and responses to patient reported 
outcome (PROs) over 12 weeks.  At Week 12, End of Study, subjects will be required to 
complete a questionnaire that addresses several aspects of feasibility of participating in 
the study. 

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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6.2 Study Schema 
6.3 PRO Collection—Feasibility and Efficacy Assessments 
Subjects will complete the following PROs at protocol specified timepoints as 
described in Section 6.5 and as detailed in the Schedule of Events in Section 6.7. 
Subjects with difficulty completing the PROs in Emory’s Part 11 compliant REDCap 
instance will be contacted by CRC via telemedicine or telephone. In these 
encounters, CRC will administer PRO surveys and collect symptom tracking data at 
protocol designated study time points. 

PROMIS Fatigue 7A—measures fatigue with daily activities

Insomnia Severity Scale—measures difficulty sleeping

PROMIS Cognitive 6A—measures difficulty thinking and concentrating

DePaul Symptom Questionnaire (DSQ-1) Short form—measures post-
exertional malaise

COMPASS 31—measures symptoms of dysautonomia

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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
WHO Disability Assessment Schedule (WHODAS 2.0)—measures health and 
disability

Headache Diary—measures the number and severity of headaches 
(completed daily during the 7 days prior to study visit)

Self-reported Persistent Symptoms Survey—measures presence or absence 
of Long COVID symptoms and their severity

Concomitant Medications Log—records subject-reported medications, 
supplements and vitamins

Self-reported Changes to Health Log—records subject-reported adverse 
events 

IP Adherence Log—records subject-reported adherence to IP dosing regimen 

End of Study Survey—assesses the feasibility and acceptability of methods 
and procedures
6.4 Safety Assessments 
Subjects will report signs and symptoms of changes to their health weekly. In 
addition to examining the subject’s electronic medical record (EMR), the CRC will 
assess for AEs and SAEs by reviewing the subject’s AE log and talking to the patient. 
AEs and SAEs will be reported as defined by 21 CFR 312. All SAEs must be followed 
until resolution/stabilization or until a time that is determined by the Investigator.
6.5 Detailed Study Procedures and Assessments by Study Period/Study Day
The procedures performed during this study will be performed according to this 
section and the Schedule of Events table shown in Section 6.7 below.
6.5.1 Screening (Within 28 days ± 3 days of Day 0): 
Prior to any study-specific procedures or data collection, the CRC will obtain 
informed consent from potentially eligible subjects.  If the subject is not an Emory 
patient, the subject will be asked to sign a medical release form.  Using a verbal 
consent, subjects will be prescreened by televisit by the CRC who will review the 
inclusion/exclusion criteria. Subjects who remain interested and are potentially 
eligible will then be consented, and medical records will be sought from the 
subject’s healthcare system to confirm eligibility. 
The following procedures and data collection will be performed during Screening:

Signature of electronic Informed Consent Form and provision of subject 
information 

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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
Collection of sociodemographic data

Medical record review

Collection of medical and surgical history, including acute COVID-19 history, 
PASC history (time from symptom onset or positive SARS-CoV-2 testing), and 
COVID-19 vaccination status

Assessment routine concomitant medications  

Assessment of baseline PROs:

WHODAS 2.0 36-item score

PROMIS Fatigue 7a

Insomnia Severity Index

PROMIS Cognitive Function Short Form 6A

DSQ-PEM Short Form

Headache Diary (completed daily during the 7 days prior to visit)

COMPASS 31

Confirm Inclusion and Exclusion criteria
6.5.2 Randomization/Day 0 will be a televisit with the study physician for a 
baseline evaluation to confirm eligibility. Study clinician will confirm adequate 
hepatic and renal function after onset of Long COVID symptoms through review 
of participant’s labwork in historical medical records. Study clinician will confirm 
negative pregnancy status in participants capable of becoming pregnant via 
urine or serum β-HCG within 30 days of randomization/Day 0. Women of 
childbearing potential who don't anticipate a pregnancy test at a clinician’s office 
within 30 days of randomization will be mailed a urine pregnancy test kit by 
study staff. Subjects will take the pregnancy test during the Randomization/Day 
0 televisit and show the result to the study physician.  If additional physical exam 
is needed per study physician discretion, the study physician will conduct a 
telemedicine exam of the following systems: Constitution, Head, eyes, ears, nose 
and throat, Cardiovascular, Respiratory, Gastrointestinal, Genitourinary (CVA 
tenderness per subject exam), Musculoskeletal, Skin, Neurological, 
Psychological. Subjects will be asked to report their most burdensome PASC 
symptom at Day 0. 
Upon confirmation of eligibility, subjects will be randomized as described in 
Section 6.1 and shown in Section 6.2. 
6.5.3 Day 1: Participant receives IP and self-administers. 

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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6.5.4 Days 2-84: Participant takes IP daily
6.5.5 Weekly: Participant completes adverse event log, study medication 
adherence log, concomitant medication log, self-reported persistent symptoms 
questionnaire
6.5.6 Days 42, 63, and 84, all +/- 3 days, subjects enter patient reported 
outcome (PRO) data into REDCap. 

PRO data to be collected
o
WHODAS 2.0 36-item score
o
PROMIS Fatigue 7a
o
Insomnia Severity Index
o
PROMIS Cognitive Function Short Form 6A
o
DSQ-PEM Short Form
o
Headache Diary (completed daily during the 7 days prior to 
visit)
o
COMPASS 31
6.5.7 Day 84/End of Study (EOS) or Early Termination: Participants complete 
End of Study survey
6.6 Subject Contact Schedule
Subject contact will occur at designated time points per protocol via televisit or phone 
call. To ensure data quality, study personnel may contact subjects at unscheduled 
timepoints to obtain clarifying information on adverse events, provide supplemental 
training on REDCap data entry, or to remind overdue participants to complete the 
scheduled patient-reported outcome surveys according to the study schedule. Study 
subjects may also initiate unscheduled contact with study staff for help with any 
questions, concerns, or difficulties. 

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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6.7 Schedule of Events
7. Statistical Analysis Plan
 
7.1 General Considerations and Overall Design
Prior to performing any analyses, the data will be 1) screened for entry errors; 2) 
checked for outliers; 3) assessed for patterns of missing data.  
7.2 Population for Analysis
The following populations will be used in the analyses:

Intent-to-treat (ITT): All subjects who received at least one intake of IP.  Subjects 
will be analyzed according to their assigned treatment.

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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
Per protocol (PP): All subjects in the ITT population who were free from major 
protocol violations that could lead to bias

Safety: All subjects who received at least one intake of IP.  Subjects will be 
analyzed according to the treatment they actually received.
7.3 Analysis for Primary Outcome
We will tabulate responses to determine frequency of difficulty understanding IP 
schedule, difficulty adhering to dosing schedule, difficulty using the REDCap 
interface, satisfaction with online study procedures, satisfaction with study staff 
interactions and availability, satisfaction with the frequency and volume of data 
collection, and difficulty with completing surveys. We will review comments 
from participants to identify barriers and facilitators to optimize the full-scale 
TLC trial. 
7.4 Analysis for Secondary Outcomes
7.4.1 Attrition
Attrition will be tabulated as the proportion of subjects who complete at 
minimum 70% of surveys at 12 weeks, the proportion of subjects who complete 
at minimum 70% of doses through 12 weeks, the proportion of subjects Lost to 
Follow Up (LTFU), and the % subjects that voluntarily terminate participation. 
7.4.2 Safety 
AEs and SAEs will be tabulated by preferred term using the Medical Dictionary 
for Regulatory Activities (MedDRA), by System Organ Class (SOC) and by severity. 
The subset of AEs that are assessed by the Investigator as having a relationship 
to the IP will be considered to be treatment-related AEs. The number and 
percentage of AEs and treatment-related AEs will be tabulated by treatment arm 
and overall. AEs will also be summarized by severity, relatedness and 
seriousness. AEs will be analyzed both by ITT and by treatment received, in the 
Safety Population. Comparisons of rates of AEs will be presented descriptively. 
7.5 Analysis for Exploratory Outcomes
7.5.1 Efficacy 
Responses to ePROs (WHODAS 2.0 36-item score, PROMIS Fatigue 7a, Insomnia 
Severity Index, PROMIS Cognitive Function Short Form 6A, DSQ-PEM Short Form, 

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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Headache Diary, COMPASS 31) will be tabulated and change in response 
between baseline and each study visit (6, 9, 12 weeks) will be calculated. 
Comparisons of changes in responses will be made between subjects receiving 
study drug versus placebo.  
7.5 Subject Disposition
The disposition of all subjects in the various populations will be summarized by 
treatment arm as follows:

Number of subjects randomized

Number of subjects who completed the study

Number of subjects who discontinued IP

Number of subjects who withdrew from the study

Number of subjects lost to follow-up
All subjects who discontinued the study will be listed by treatment arm with the reason 
for discontinuation, if available
8. Data and/or Specimen Banking
Data will be shared among members of the study team with appropriate access based on 
study role, training, and delegation of authority. Data will be made available to assigned 
study monitors, the appropriate oversight authorities, the Food and Drug Administration, 
and other state and federal regulatory authorities as required by state and federal law.
De-identified data may be shared for future research. Requests will be evaluated on a case-
by-case basis by PI. No data will be released without proof of IRB approval or 
determination. Agreements as required by local policies will be completed when necessary, 
including data use agreements and material transfer agreements.
The study will be registered with one or more recognized clinical study registries, e.g., 
www.clinicaltrials.gov.
All data and results and all intellectual property rights in the data and results derived from 
the study will be the property of the Sponsor who may utilize them in various ways, such as 
for submission to regulatory authorities or shared with research institutions, as needed.  
The final Clinical Study Report will be submitted to the ethics committee and regulatory 
authorities, if required.

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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The Sponsor encourages the communication and/or publication of the results by the 
consortium of partners in accordance with the terms of the Clinical Trial Agreement.
Subjects will have the option of consenting to be contacted for future related studies. If 
subjects choose this option, their name and contact information will be stored in a 
password-protected file stored on a secure, Emory server. 
9. Sharing of Results with Participants
Individual subject results will not be shared with participants. Participants interested in 
knowing their randomization assignment may request that staff release that information 
after unblinding occurs after database lock. Participants desiring study results may request 
that staff provide them links to any publications resulting from the trial.   
Incidental findings are not anticipated in this study because there are no investigational 
diagnostic tests. However, if we discover a medical issue that is unrelated to the purpose of 
this study, we will share that information if it is of urgent medical importance.
10. Study Timelines

The duration of participation for each individual subject will be 16 weeks—4 weeks 
Screening, 12 weeks Treatment. 

Based on the current epidemiology, the duration of recruitment should be 
approximately four (4) months from first subject enrolled.

Last subject last visit is anticipated to occur in August 2024. The estimated date for the 
investigators to complete primary analyses is February 2025.
 
11. Inclusion and Exclusion Criteria

CRC will pre-screen Emory and Grady PASC Clinic patients for potential eligibility via 
chart review and will contact the clinic physician regarding potentially eligible patients. 
CRC will request clinic physician advise patients of the study and provide CRC/study 
team contact information to interested patients. CRC/study team will describe the study 
to these potential subjects and will send the ICF to interested patients for the ICF 
discussion.

Non-Emory subjects will contact CRC/study team in response to recruitment 
advertisements. CRC/study team will confirm the potential subject is 18 years of age or 
older and a Georgia resident with new or worsened symptoms of interest since onset of 
COVID-19 that have lasted for ≥ 12 weeks. CRC/study team will describe the study to 

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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these potential subjects and will send the ICF to interested subjects to conduct the ICF 
discussion.

Potential subjects will not complete baseline questionnaires and CRC/study team will 
not conduct a full medical/surgical history and concomitant medication review for 
inclusion/exclusion prior to the subject signing the ICF. 
 
Inclusion Criteria: A subject must meet all of the following criteria to be eligible for this 
study:
1. Adults ≥18 years of age with history of a SARS-CoV-2 PCR positive test and/or 
medical records from healthcare provider that coincides with the diagnosis of long-
COVID 
2. New or worsened symptoms since 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).
3. Confirmation of negative urine or serum HCG (pregnancy) test in women of child-
bearing potential
4. Willing to use appropriate contraceptive for female and male subjects for the 
duration of the study
5. Has an address (for mailing of IP) in the state of Georgia
6. Able to swallow capsules
7. Has reliable access to a mobile phone, tablet, laptop, or desktop computer capable 
of connecting to the internet via WiFi or a data plan 
8. Available lab work (CBC and CMP) after onset of long COVID symptoms 
9. Willing and able to comply with scheduled visits, treatment plan, and other study 
procedures including receiving either intervention or placebo
10. Willing to not take any of the study medications while enrolled in the study except 
for essential need as prescribed by a healthcare provider
Exclusion Criteria: A subject who meets any of the following criteria will be excluded from 
this study:
1. No PASC symptoms at the time of enrollment or PASC symptoms present <12 weeks 
at the time of enrollment
2. Inability to provide own informed consent
3. Currently hospitalized

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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4. For Women of Child Bearing Potential (WOCBP)*: currently pregnant or plans to 
become pregnant during study period; for males with partners OCBP, plans to 
become pregnant during study period
5. 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
6. Unstable medical comorbidities (e.g., decompensated cirrhosis, stage III-IV chronic 
kidney disease, NYHA class III congestive heart failure), per subject report, 
telemedicine physical exam, baseline laboratory values (hematology and extended 
chemistry panels) and/or medical records
7. Other medical conditions occurring either before or after onset of COVID-19 that can 
otherwise account for PASC-type symptoms (examples include, but are not limited 
to: uncontrolled thyroid disease, adrenal insufficiency, chronic fatigue syndrome, 
Postural Orthostatic Tachycardia Syndrome (POTS), among others). This will be up to 
the discretion of the study physician.
8. Currently immunocompromised from the following: solid organ transplant, BMT, 
high dose steroids (>20mg prednisone per day), immune modulators, or 
chemotherapy
9. Currently taking opioid analgesics, undergoing treatment for opioid addiction, or 
taking any other prohibited concomitant medication
10. Opioid dependence or withdrawal syndrome
11. Known sensitivity or adverse reaction to H1 or H2 receptor antagonists, or 
medication components
12. Suspected or confirmed pregnancy or breastfeeding
13. Already on H1 or H2 receptor antagonists within 3 months of randomization 
14. Currently receiving other therapies to treat COVID-19 or Long COVID symptoms, e.g., 
convalescent plasma, remdesivir, Paxlovid
*WOCBP are defined as a person of childbearing ability who has not had a hysterectomy and/or 
both tubes and/or both ovaries removed and/or is not postmenopausal and over the age of 45).
12. Population
The study population will consist of Georgia residents ages ≥18 years with new or worsened 
symptoms since the onset of COVID-19 that are persistent at the time of enrollment and have 
lasted for ≥ 12 weeks. Subjects must have at least one of the following PASC symptoms:  
fatigue, post-exertional malaise (PEM), headache, brain fog, sleep disturbance, or 
dysautonomia. 
The following special populations will not be enrolled in this study: 

Adults unable to consent

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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
Individuals who are not yet adults (infants, children, teenagers)

Pregnant women

Prisoners

Cognitively impaired or Individuals with Impaired Decision-Making Capacity

Individuals who are not able to clearly understand English
This study will use the 2020 US Census classifications for race and ethnicity data as established 
in the 1997 Office of Management and Budget (OMB) Standards and described at: 
https://www.govinfo.gov/content/pkg/FR-1997-10-30/pdf/97-28653.pdf. Race categories will 
include American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or 
Other Pacific Islander, White and Some Other Race. More than one race may be selected. 
Ethnicity will ask if subjects are or are not of Hispanic, Latino/a/x or Spanish origin.  Both race 
and ethnicity will include a write-in section in which participants can self-identify.  
 
Racial and ethnic classifications of subjects will be used for descriptive statistics, but will not be 
used within an explanatory model (as a covariate). 
13. Vulnerable Populations
This trial will not enroll subjects who are members of vulnerable populations. 
14. Local Number of Participants
24 subjects are needed to complete the research procedures. We anticipate enrolling and 
screening approximately 36 subjects to reach this goal, given screen failure and possible 
study drop-out/withdrawal. Screen failures will be replaced; drop-out/withdrawal/lost to 
follow-up will not be replaced. Participants will be drawn from the state of GA. We project 
enrollment to reflect the incidence of PASC between the sexes of 70% female and 30% 
male. PASC incidence among races is unknown. 
15. Recruitment Methods
Recruitment will be done through a two-pronged approach utilizing direct engagement with 
Long COVID clinics at Grady and Emory. 
We will engage with clinicians at PASC and primary care clinics at Emory and Grady. 
Promotion will entail a combination of direct outreach and education from our team along 
with materials such as flyers and pamphlets.
The study team will review medical records for Emory and Grady PASC Clinic patients to 
identify potentially eligible prospective subjects, per protocol Section 11 Inclusion and 
Exclusion Criteria. 

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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Finally, we will share our graphics with Emory’s communications team and request 
placement on their website and dissemination of information about the trial.     
16. Withdrawal of Participants
Participants may discontinue IP or withdraw from the study at any time and for any reason 
without prejudice to their medical care. Furthermore, the PI may discontinue a subject from 
IP or withdraw them from study procedures. The reason for the patient’s discontinuation or 
withdrawal will be recorded in REDCap.
16.1 Discontinuation of IP
Discontinuation refers to the subject stopping IP administration. Subjects who 
discontinue IP should, with their consent, continue participating in the study, 
completing all visits and assessments as scheduled.  The reason for IP discontinuation 
will be recorded in REDCap.  
Possible reasons for IP discontinuation are:

If the subject requests discontinuation of treatment with IP 

If the subject requires treatment with a prohibited concomitant medication 

If the subject develops contraindications to any of the IPs

If clinical reasons arise where the harm is considered to outweigh the benefits by 
the Investigator

If the subject no longer meets inclusion/exclusion criteria  

Occurrence of intolerable adverse reactions and pregnancy

Unblinding (accidental or medically necessary) of subject, investigator, or study 
staff
16.2 Withdrawal from Study Procedures
Withdrawal refers to a study participant’s stopping IP and all study assessments and 
visits. 
If a subject withdraws his/her consent for future collection of information, the 
Investigator may retain and continue to use any data collected before consent was 
withdrawn.
Every effort should be made to ensure that subjects who withdraw or are withdrawn 
undergo an early withdrawal study visit as soon as possible.
Possible reasons for withdrawal include: 

The subject requests to withdraw 

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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
The subject withdraws consent to the collection, use and sharing of his/her data

The Investigator thinks that study participation is no longer in the best interest of 
the subject

The Investigator thinks that the subject is at significant risk of failing to comply 
with the provisions of the protocol so as to cause harm to her/himself or seriously 
interfere with the validity of the study results

At the request of the ethics committee or regulatory authorities in the exercise of 
their duties

Loss to follow-up

The study is terminated
All data from subjects withdrawn from the study may be analyzed up until time of 
withdrawal.
16.3 Loss to Follow-Up
A study subject will be considered lost to follow-up if s/he stops entering data into 
REDCap and can no longer be contacted by study personnel. Before the subject can be 
considered as lost to follow-up, study personnel must make every effort to re-establish 
contact with a minimum of 3 documented contact attempts by phone, text and/or 
email. These contact attempts will be documented in a note in the subject’s study 
record in REDCap. Information on subject status, i.e., alive or dead, hospitalized, should 
be collected and procedures for AE/SAE followed as appropriate.
If all attempts to re-establish contact with the subject are unsuccessful, s/he will be 
considered to have withdrawn from the study and the primary reason of loss to follow-
up will be recorded in the eCRF, if available.
16.4 Screen Failure
A subject who discontinues study participation for any reason after signing the informed 
consent form but before randomization, is regarded as a “screen failure.”
17. Risk to Participants 
The most important risks or discomforts a participant may expect from taking part in this 
research are the common side effects of the IPs.
17.1 Cetirizine

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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Cetirizine is a well-tolerated nonprescription drug. Common side effects (greater than 
2%) include somnolence, fatigue, dry mouth, pharyngitis, dizziness, headache, and 
nausea. Other adverse events, including serious adverse events, as reported in the label, 
were observed infrequently (less than 2%) in U.S. trials with more than 3,500 adults and 
children 12 years and older. No causal relationship of these infrequent events with 
cetirizine administration has been established.  
17.2 Famotidine
Famotidine is a well-tolerated nonprescription drug. Common side effects (greater than 
1%) that have been observed in controlled clinical trials and may be causally related to 
famotidine therapy include headache, dizziness, constipation, and diarrhea. The 
marketing label reports other adverse reactions, including serious adverse reactions 
observed infrequently in clinical trials and post-market surveillance. The relationship of 
these adverse reactions to famotidine therapy is unclear.  
17.3 Prohibited Concomitant Medications
For further details concerning warnings, precautions, and contraindications, refer to 
package inserts. During the study, participants cannot take the following medications 
outside of the IP: antihistamines (cetirizine, loratadine) anti-acid H2 blockers 
(famotidine, ranitidine), naltrexone, suboxone, methadone, tramadol, Paxlovid, or 
opioids. 
18. Potential Benefits to Participants
There are currently no treatments known to be effective for PASC. Individual participant’s 
Long COVID symptoms may improve or resolve.
19. Compensation to Participants
Subjects will receive a $50.00 stipend for their time and effort upon completion of the 
Screening Phase, and after completion of study assessments at Days 42, 63 and 84 (Weeks 
6, 9 and 12). 
Completion of the Screening Phase is defined as 1. completing all baseline assessments, 
with or without assistance from the study team, and 2. completing the Day 0 visit. Subjects 
who complete both elements, whether they screen fail or randomize, will be eligible for a 
stipend. As baseline assessments are essential to ensuring subject safety and eligibility, 
subjects who consent but don’t complete all assessments, withdraw or are withdrawn prior 
to the Day 0 visit, or are lost to follow up during screening are ineligible to receive the 
$25.00 stipend. 

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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Stipends will be issued via reloadable debit card, e.g., GreenPhire ClinCard.  Tax information 
is not required as total possible compensation is $200.00. Subjects who withdraw early will 
receive payment for any visits for which stipends are paid that they complete. 
20. Data Management and Confidentiality
20.1 Survey Data Collection
Participants will be asked to record their IP adherence, report initiation of new routine 
medications, and report adverse side effects weekly throughout the trial on electronic 
forms in Emory’s Part 11 compliant REDCap instance. 
Adherence with taking the medication will be assessed via self-report weekly in REDCap.
In all protocol-specified data, subjects will be identified only by coded numbers in order 
to maintain confidentiality. 
20.2 Clinical Data Collection
Clinical data on comorbid diseases, lab values, e.g., CBC, CMP, medications, acute 
COVID-19 disease course and treatment, as described above, may be collected from 
participants’ EHR using participant name and medical record number.  
20.3 Data Handling and Integrity
Case report form data will be entered in and maintained on a 21 CFR part 11 compliant 
Electronic Data Capture system (EDC) with appropriate access controls via Emory’s Part 
11 compliant REDCap instance. Both study subjects and study staff will enter data into 
this system.
All standard confidentiality procedures will be observed for this study. Research staff 
will be trained on protocol and GCP standards before they will be allowed contact with 
participants or data. All data will be stored in a secure HIPAA compliant manner. No 
subject identifiable data will be stored on individual research computers or flash drives. 
The Trial Master File (TMF) will be electronically maintained in Emory’s OneDrive, with 
access restricted to the Sponsor, Lead CRC and assigned PM, if applicable. CRCs will 
grant access to the assigned CRA upon request on an as needed basis.  
The Investigator Site File (ISF) will be electronically maintained in Emory’s OneDrive with 
access restricted to the PI, SIs, and CRC. CRCs will grant access to the assigned CRA upon 
request on an as needed basis.

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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The site will maintain an electronic screening log in Emory’s OneDrive containing the 
screening number, name, date of birth, age, sex and, if applicable, reason for screen 
failure. An electronic Subject ID log of all subjects randomized in the study will also be 
kept in Emory’s OneDrive. This log will contain Subject ID Number, name, address, 
telephone number, email, emergency contact name and phone number. Access to both 
these logs will be restricted to the PI, SI and CRC. 
The PI will manage oversight of quality control for collected data. Enrollment of subjects 
will be performed using inclusion/exclusion criteria defined above. Study data will be 
recorded into a REDCap database, which is HIPAA compliant, part 11 compliant, 
password protected with variable assignable security access, and maintains an audit trail 
consistent with all regulatory requirements for maintenance of clinical trial data. Data 
summaries and quality control checks will be run routinely.
Data collection, review and entry will be performed by trained members of the research 
team who have received documented delegation of authority. Data integrity will be 
overseen by the PI. A study monitor will review the electronic consent documents, IP 
administration data, and SAE reporting. At the monitor’s discretion, a random sampling 
of subjects may undergo full evaluation and comparison of source documentation with 
data entered into the study database.
20.4 Missing Data
Research coordinators will make a consistent effort to ascertain all study data within the 
protocol specified windows, as well as outside these windows as needed. Participants 
who fail to respond will be contacted by study staff multiple times, and emergency 
contacts may be contacted as well, prior to being recorded as lost to follow-up. All data 
collected on a participant prior to loss to follow-up or withdrawal of consent will be 
included in analyses. 
20.5 Data from Screen Failures
The following minimum data will be recorded in the eCRF for screen failures:

Subject identification number

Demographic data, i.e., sex, year of birth and/or age

Reason for screen failure

Date of ICF signature

Date of Screen Failure

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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20.6 Protection of Confidentiality
All standard confidentiality procedures will be observed for this study. Research staff 
will be trained on protocol and GCP standards before they will be allowed contact with 
participants or data. All data will be stored in a secure HIPAA compliant manner. No 
subject identifiable data will be stored on individual research computers or flash drives. 
Data transfers will contain only deidentified data; subjects will be identified only by 
coded numbers. Subject data will only be released with the subject’s written permission, 
except as necessary for monitoring, auditing, or inspection by authorized entities. If the 
results of the study are published, the subject’s identity will remain confidential.
21. Plans to Monitor the Data to Ensure Safety of Participants and Data Integrity
X More than minimal risk   
Review our Data and Safety Monitoring Questionnaire and insert the relevant monitoring 
table at the end of this section. Also upload the completed questionnaire in the “Basic Study 
Information” smartform section in eIRB, question #8, as a separate document. 
Mark the risk categorization, as determined by the Data and Safety Monitoring 
Questionnaire, that applies to your study below:
Select one of the following (do not delete this table; review the guidance document 
for definitions):
☐ Medium Complexity
☐ High Complexity Category A
☒ High Complexity Category B
If choosing this category for a study under an IND or IDE because you believe the 
study intervention does not significantly impact morbidity or mortality, please 
provide your rationale: 
The IPs are FDA approved and will be administered at doses which are within 
the recommended doses for the registered indications of the products 

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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DSMP 
Requirement
How this Requirement is 
Met 
Frequency
Responsible 
Party(ies)
Site Monitoring at 
pre-determined 
intervals: The 
Principal 
Investigator has a 
responsibility to 
ensure that the 
study is following 
all aspects of the 
protocol. 
There should be a 
standard operating 
procedure to review data 
(whether a sample or 
100%) at pre-determined 
intervals to ensure that 
there is adequate 
documentation of critical 
elements such as eligibility 
criteria. Monitoring is 
required at the following 
timepoints (but may be 
done more frequently):

study initiation  

at least every six 
months while 
participants are 
receiving 
intervention and 

annually while 
participants are in 
follow-up
External monitoring for 
the TLC trial will be 
performed by 
IND2Results, a CRO. 
IND2Results will draft an 
independent monitoring 
plan.
At a minimum, a review is 
required annually when no 
one has been enrolled or the 
study is in long term follow 
up. Additional risk-based 
interim monitoring may be 
required at least once every 
12-24 weeks based on the 
site activity, to include the 
possibility of remote 
monitoring. A longer 
frequency could be 
acceptable with justification 
about risk to participants.
The IND2Results monitoring 
plan, at minimum, will 
include monitoring after the 
first participant is enrolled, 
every six months while 
participants are receiving 
intervention and annually 
while participants are in 
follow-up.
Delegate a 
responsible 
party for 
each 
requirement 
below. Self-
assessment is 
acceptable.*
Self-
assessment: 
a process for 
self-
assessment 
of protocol 
compliance 
and data 
integrity 
which can be 
part of an 
overall 
DSMP. 
SeeEmory’s 
self-
assessment 
tool on this 
page. 
Site 
monitoring 
by external 
monitor(s) 
will be 
performed 
by 
IND2Results 
according to 
the 

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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monitoring 
plan.
Real-time review 
of participant data 
during initial data 
collection.
To ensure that all 
pertinent data is 
accurately captured, real-
time review will help 
prevent items from being 
overlooked.
Expectation is that this 
happens every time you 
obtain information.
Everyone on 
the study 
team 
responsible 
for primary 
data 
collection.
100% review of 
regulatory files
To ensure that the 
regulatory file is current 
and complete for this 
study, and contains all of 
the necessary regulatory 
documents, from study 
start-up, to study 
completion.
Reviewed at a minimum of 
first and close-out visits
Review can occur more 
frequently if there is 
increased activity 
(modifications/amendments, 
revised protocols, revised 
consent forms, annual 
renewal submissions, 
reportable events 
submissions, etc.).
PI, Study 
Coordinator, 
External 
Monitor(s) 
from 
IND2Results
100% review of 
consent forms
To ensure that 
participants are enrolled 
with the most current 
version of the consent 
form and that all consent 
forms are filled out 
completely.
Consent forms will be 
reviewed according to 
IND2Results’ monitoring 
plan, at a minimum:
- after the first participant is 
enrolled
- six months after the first 
participant is enrolled
- every 12 months 
thereafter
-
at the end of the 
study
PI and Lead 
Study 
Coordinator 
will review 
after each 
visit to 
obtain 
consent. 
External 
Monitor(s) 
from 
IND2Results 
will also 
review 
consent 

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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forms 
according to 
the 
monitoring 
plan.
Review of 
credentials, 
training records, 
the delegation of 
responsibility logs 
(if applicable)
To ensure that all study 
team members have 
completed the necessary 
onboarding/training 
requirements to begin 
working on this study and 
to ensure that study-
specific responsibilities 
are captured for each 
team member
Review will take place at a 
minimum of study initiation 
and at study close-out, 
however, review may occur 
if new team members are 
added to the study staff 
roster.
Study 
Coordinator, 
External 
monitor(s) 
from 
IND2Results
Comparison of 
case report forms 
(CRF) to source 
documentation for 
accuracy and 
completion
To ensure that source 
data/information has 
been captured and 
transcribed accurately to 
case report 
forms/REDCap.
Review will take place at a 
minimum of study initiation 
and at study close-out; 
however, review may occur 
if new versions of CRFs are 
released.
Study 
Coordinator, 
External 
Monitor(s) 
from 
IND2Results
Review of 
documentation of 
all adverse events
To ensure that Adverse 
Events are captured and 
reported in a timely 
manner.
Adverse Events will be 
reviewed by study staff at 
the following timepoints: 
- Individual adverse events 
will be reviewed in real-time
- An aggregate of adverse 
events will be reviewed each 
week
All study drop-outs and 
protocol 
deviations/violations will be 
reviewed each month. They 
will be reviewed by external 
CRO monitor per the  
monitoring plan.
PI, Study 
Coordinators, 
and CRO 
Study 
Monitor(s)

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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Monitoring of 
critical data points 
(eligibility, study 
endpoints, etc.)
To ensure complete 
documentation of critical 
elements such as eligibility 
criteria being met, and 
objectives being achieved
Critical data points will be 
reviewed according to 
IND2Results’ monitoring 
plan, at a minimum:
- after the first participant is 
enrolled
- six months after the first 
participant is enrolled
- every 12 months 
thereafter
-
at the end of the 
study
PI, Study 
Coordinator, 
and CRO 
Study 
Monitor(s)
Laboratory review 
of processing and 
storage of 
specimens
Not Applicable—No 
prospective labs are being 
collected in this study
N/A Reviewed at first and 
close-out visits and at least 
biannually
N/A
Assessment 
of 
laboratory 
specimens stored 
locally
Not Applicable—No 
prospective labs are being 
collected in this study; 
thus, there will no 
laboratory specimens 
stored locally
N/A
N/A
Test article 
accountability 
review
To maintain strict control 
over investigational drugs 
to ensure that the test 
article is used only for 
subjects enrolled in the 
study.
Reviewed at first and close-
out visits and at least 
biannually
PI, IDS, CRO 
Study 
Monitor(s)
Accountability 
logs, dispensing 
records, and other 
participant records 
To ensure that all IP 
dispensing counts are in 
alignment with number of 
enrollees.
Reviewed at first and close-
out visits and at least 
biannually
PI will decide if pacing of 
review needs to be adjusted.  
PI, CRC, 
Pharmacist, 
CRO Study 
Monitor(s)
For FDA regulated 
studies, the 
following 
requirements 
apply:
How this Requirement is 
Met
Timing, frequency, and 
intensity of monitoring
Responsible 
Party(ies)

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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Monitoring 
methods (may 
include 
centralized, on-
site, and self-
assessment)
To ensure this study is 
being conducted in 
accordance within the 
scope of institutional and 
federal regulations.
Monitoring for this study will 
be an ongoing and continual 
process. Monitoring for this 
fully decentralized trial will 
be done remotely by 
contracted CRO monitor(s) 
according to the monitoring 
plan
External 
Monitor(s) 
from 
IND2Results
*For international studies, you are required to engage a CRO that is working in the site country 
and/or to consult with Emory’s legal counsel regarding compliance with the country’s clinical 
research regulations.
AE/SAE attributes will include:

Start and stop dates

Severity 
o
Severity will be reported in accordance with the National Cancer Institute’s 
Common Terminology Criteria for Adverse Events (CTCAE) v.5 
o
If an appropriate listing is not present in this table for an AE, the AE will be 
graded as follows:

Grade 1 (Mild) – No interference with daily activity

Grade 2 (Moderate) – Some interference with daily activity but medical 
intervention not required (e.g., doctor visit and/or prescription 
medicine); over the counter medicine permitted

Grade 3 (Severe) – Prevents daily activity and requires medical 
intervention (e.g., doctor visit and/or prescription medicine)

Causality/ relationship to IP—Causality assessment is required for AEs (and SAEs) that 
occur during clinical investigations. There is currently no standard international 
nomenclature to describe the degree of causality or relatedness of an AE with the IP. 
The following terms will be used during this study:
o
Likely – Reasons to consider an AE likely related to treatment may include, but 
are not limited to the following: 

Timing of the event relative to the administration of the IP

Location of the AE relative to the site of IP administration

Likelihood based on experience with similar products

There is a biologically plausible explanation based on the mechanism of 
action or mode of delivery of the treatment

The AE is repeated on subsequent treatments

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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
No other explanation is likely
o
Unlikely – An AE with no temporal association with the IP but rather related to 
other etiologies such as concomitant medications or conditions, or subject's 
known clinical state.
A qualified study monitor will conduct remote risk-based monitoring of the trial to ensure that 
the study is conducted in accordance with the study protocol, ICH GCP E6, and FDA regulatory 
requirements. At the monitor’s discretion, a random sampling of subjects may undergo full 
evaluation and comparison of source documentation with data entered into the study 
database. 
The first data monitoring visit will be scheduled within an appropriate time after the first 
subject is enrolled, with subsequent visits thereafter at designated time intervals per the 
monitoring plan. Monitors will evaluate study team members to ensure access is consistent 
with training and delegation of authority logs.
The Investigator and the head of the medical institution, if applicable, agrees to allow the 
monitors direct access to all study-related documents.
Language for Reporting as a Sponsor
Written IND safety reports will be submitted to the FDA by the IND sponsor, for serious, 
unexpected suspected adverse reactions within 15 calendar days of learning of its occurrence. If 
the event is fatal or is deemed to be life threatening, the report will be made within 7 calendar 
days.  The IND sponsor will also make an assessment of whether the event constitutes an 
unanticipated problem posing risks to subjects or others (UP). This assessment will be provided 
to the Emory University IRB, which, in turn will make a final determination.  If the Emory IRB 
determines an event is a UP it will notify the appropriate regulatory agencies and institutional 
officials.
22. Provisions to Protect the Privacy Interest of Participants
22.1 Protection of Privacy 
The electronic consent process and any televisits will take place using the secure and 
HIPAA compliant Emory Zoom and Emory’s Part 11 compliant REDCap instance. 
Whether televisit or telephone call, study staff will ensure the potential subject is in a 
location with their desired level of privacy prior to beginning the visit. If the results of 
the study are published, the subject’s identity will remain confidential.

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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Participants enrolled in the trial are made aware during the informed consent procedure 
that study personnel will be required to access the study subject’s private medical 
records for trial conduct, and consent to this access prior to agreeing to participate. 
 22.2 Access to Participants
Conduct of the study and determination of feasibility of methods and procedures and 
safety evaluations of the intervention require access to the study subject’s medical 
records. All study personnel undergo human subjects protection training and 
understand and value privacy standards set forth by HIPAA. Participants enrolled in the 
trial are made aware during the informed consent procedure that study personnel will 
be required to access this private information for trial conduct, and consent to this 
access prior to agreeing to participate. 
23. Economic Burden to Participants
There will be no costs to the participant for participating in this study. Participants will not 
be charged for any of the research activities. Any IP that is required during the trial will be 
provided free of charge. If the medication results in an AE or if study procedures result in 
any medical complications, the cost of treatment for those complications may be charged to 
the participant or their insurer.  In the event of non-related AEs, the cost will be paid by the 
participant or their insurer.
24. Informed Consent 
To preliminarily determine whether an interested party may be a candidate for this study, 
delegated research staff will obtain verbal consent and conduct a screening interview using 
a standardized pre-screen questionnaire. The verbal consent will describe the information 
to be collected during the screening interview and explain what will be done with the 
collected information. The pre-screen questionnaire will permit the study team to apply 
inclusion/exclusion criteria at a high-level to eliminate clearly ineligible candidates.
Written informed consent will be obtained by delegated research staff before beginning any 
study procedures. The consent conversation will be conducted remotely with the ICF 
presented to the participant as an electronic document (eConsent) through Emory’s Part 11 
compliant REDCap instance.
The entire informed consent form (ICF) will be reviewed with potential study subjects 
including all study procedures and expectations, risks, benefits, and what volunteering 
means. Participants will be asked questions to gauge their level of understanding. Potential 
participants will be given time to read the ICF and ask questions. If a potential participant 

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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needs additional time to review the ICF or discuss study participation with family/friends, 
study staff will accommodate by scheduling a follow-up informed consent visit.
The PI may delegate qualified non-licensed study staff to obtain informed consent. If 
potential subjects have a medical-related question outside of the delegated person’s scope 
of practice, or request to speak directly with a licensed person, the non-licensed staff 
member will contact the PI or any SIs. If the PI/SI are not available, study staff will 
accommodate by scheduling a follow-up informed consent visit.

Non-English-Speaking participants will not be enrolled in this pilot study. Costs for 
translation of study documents and interpreters are prohibitive for the small budget 
of this pilot trial.

Subjects who are not yet adults will not be enrolled in this study. 

Cognitively impaired adults will not be enrolled in this study. 
o
Study Coordinators may assess potential subjects for decisional capacity; 
however, the PI is responsible for the ultimate determination as to an 
individual’s capacity for consent. 

Adults unable to provide their own consent will not be enrolled in this study.
25. Setting 
As this is a decentralized study all study-related visits and interactions will occur remotely. 
Informed consent and televisits will take place using Emory University’s Part 11 compliant 
instance of REDCap and Zoom platforms.  
PI operates out of 
26. Resources Available

Based on the current epidemiology, the duration of recruitment should be 
approximately four (4) months from first subject enrolled. 

Emory University and the U.S. Food and Drug Administration (FDA), in conjunction with 
the Critical Path Institute’s CURE Drug Repurposing Collaboratory (C-Path/CDRC), for the 
purposes of Office of the Assistant Secretary for Planning and Evaluation (ASPE) are 
collaborating in the design and conduct of a platform randomized trial infrastructure. 
(Prime Grant Number: 2U18FD005320)
o
C-Path/CDRC will serve as the administrative coordinating center
o
C-Path/CDRC is providing a dedicated employee (CRC IV) for trial coordination 
and management.

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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o
The PI and CRC will be responsible for screening, enrollment, randomization, and 
physician confirmation of eligibility criteria on study participants, obtain baseline 
study data, and follow patients prospectively at 6, 9, 12 weeks with electronic 
patient reported outcomes (ePROs) per study protocol 

There are no anticipated consequences of the human research for which participants 
might need medical or psychological resources. 
o
Subjects will be advised that if they are injured or get sick, they should go to the 
emergency room or other urgent care provider, as well as call the study doctor 
immediately.

All study personnel will be trained on the protocol, have current certificates 
documenting GCP training and human subjects research ethics training, and receive 
documented delegation of authority for study tasks. Monitors will evaluate
study team members to ensure access is consistent with training and delegation of 
authority logs.

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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27. References
1. The Corona Virus Disease 2019 (COVID-19) 2021 Case Definition. Centers for Disease 
Control and Prevention. https://ndc.services.cdc.gov/case-definitions/coronavirus-
disease-2019-2021/. 
2. Mayrink, J., Souza, R. T., Silveira, C., Guida, J. P., Costa, M. L., Parpinelli, M. A., Pacagnella, 
R. C., Ferreira, E. C., Sousa, M. H., Say, L., Chou, D., Filippi, V., Barreix, M., Barbour, K., von 
Dadelszen, P., Cecatti, J. G., & Brazilian Cohort on Severe Maternal Morbidity (COMMAG) 
study group and the WHO Maternal Morbidity Working Group (MMWG) Reference ranges 
of the WHO Disability Assessment Schedule (WHODAS 2.0) score and diagnostic validity 
of its 12-item version in identifying altered functioning in healthy postpartum women. 
International journal of gynaecology and obstetrics: the official organ of the International 
Federation of Gynaecology and Obstetrics, 2018. 141 Suppl 1, 48–54.
3. Diggle JP, H.P., Liang KY, Zeger SL., Analysis of Longitudinal Data (2nd ed). Oxford 
University Press, UK. 2002.
4. Hauck, W.W., S. Anderson, and S.M. Marcus, Should we adjust for covariates in nonlinear 
regression analyses of randomized trials? Control Clin Trials, 1998. 19(3): p. 249-56.
5. Fitzmaurice GM, L.N., Ware JH. , Applied Longitudinal Analysis. John Wiley & Sons, New 
Jersey. 2011.
6. Guan, W.J., et al., Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J 
Med, 2020. 382(18): p. 1708-1720.
7. Li, Q., et al., Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected 
Pneumonia. N Engl J Med, 2020. 382(13): p. 1199-1207.
8. WHO. WHO Coronavirus (COVID-19) Dashboard.  [Access date 2/2/2023].
9. Arnold, D.T., et al., Patient outcomes after hospitalisation with COVID-19 and implications 
for follow-up: results from a prospective UK cohort. Thorax, 2021. 76(4): p. 399-401.
10. Carfì, A., R. Bernabei, and F. Landi, Persistent Symptoms in Patients After Acute COVID-19. 
Jama, 2020. 324(6): p. 603-605.
11. Carvalho-Schneider, C., et al., Follow-up of adults with noncritical COVID-19 two months 
after symptom onset. Clin Microbiol Infect, 2021. 27(2): p. 258-263.
12. Garrigues, E., et al., Post-discharge persistent symptoms and health-related quality of life 
after hospitalization for COVID-19. J Infect, 2020. 81(6): p. e4-e6.
13. Huang, C., et al., 6-month consequences of COVID-19 in patients discharged from hospital: 
a cohort study. Lancet, 2021. 397(10270): p. 220-232.
14. Jacobs, J.J.L., Persistent SARS-2 infections contribute to long COVID-19. Med Hypotheses, 
2021. 149: p. 110538.
15. Mandal, S., et al., 'Long-COVID': a cross-sectional study of persisting symptoms, biomarker 
and imaging abnormalities following hospitalisation for COVID-19. Thorax, 2021. 76(4): p. 
396-398.
16. Moreno-Pérez, O., et al., Post-acute COVID-19 syndrome. Incidence and risk factors: A 
Mediterranean cohort study. J Infect, 2021. 82(3): p. 378-383.
17. Petersen, M.S., et al., Long COVID in the Faroe Islands - a longitudinal study among non-
hospitalized patients. Clin Infect Dis, 2020.
18. Davis, H.E., McCorkell, L., Vogel, J.M. et al. Long COVID: major findings, mechanisms and 
recommendations. Nat Rev Microbiol (2023).  
19. Del Rio, C., L.F. Collins, and P. Malani, Long-term Health Consequences of COVID-19. Jama, 
2020. 324(17): p. 1723-1724.

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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20. Liotti, F.M., et al., Assessment of SARS-CoV-2 RNA Test Results Among Patients Who 
Recovered From COVID-19 With Prior Negative Results. JAMA Intern Med, 2021. 181(5): 
p. 702-704.
21. Sun, J., et al., Prolonged Persistence of SARS-CoV-2 RNA in Body Fluids. Emerg Infect Dis, 
2020. 26(8): p. 1834-1838.
22. Gaebler, C., et al., Evolution of antibody immunity to SARS-CoV-2. Nature, 2021. 
591(7851): p. 639-644.
23. Bao, C., et al., Natural killer cells associated with SARS-CoV-2 viral RNA shedding, antibody 
response and mortality in COVID-19 patients. Exp Hematol Oncol, 2021. 10(1): p. 5.
24. van Eeden C, K.L., Osman MS, Cohen Tervaert JW. , Natural Killer Cell Dysfunction and Its 
Role in COVID-19. Int J Mol Sci. 2020;21(17):6351.
25. Afrin, L.B., L.B. Weinstock, and G.J. Molderings, Covid-19 hyperinflammation and post-
Covid-19 illness may be rooted in mast cell activation syndrome. Int J Infect Dis, 2020. 100: 
p. 327-332.
26. Bastard, P., et al., Autoantibodies against type I IFNs in patients with life-threatening 
COVID-19. Science, 2020. 370(6515).
27. Wang, E.Y., et al., Diverse functional autoantibodies in patients with COVID-19. Nature, 
2021. 595(7866): p. 283-288.
28. Zuo, Y., et al., Prothrombotic autoantibodies in serum from patients hospitalized with 
COVID-19. Sci Transl Med, 2020. 12(570).
29. Bolton, M.J., B.P. Chapman, and H. Van Marwijk, Low-dose naltrexone as a treatment for 
chronic fatigue syndrome. BMJ Case Rep, 2020. 13(1).
30. Bateman, L., et al., Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Essentials of 
Diagnosis and Management. Mayo Clin Proc, 2021. 96(11): p. 2861-2878.
31. Cabanas, H., et al., Potential Therapeutic Benefit of Low Dose Naltrexone in Myalgic 
Encephalomyelitis/Chronic Fatigue Syndrome: Role of Transient Receptor Potential 
Melastatin 3 Ion Channels in Pathophysiology and Treatment. Front Immunol, 2021. 12: 
p. 687806.
32. Toljan K, V.B., Low-Dose Naltrexone (LDN)-Review of Therapeutic Utilization. Med Sci. 
2018;6(4):82.
33. Glynne, P., et al., Long-COVID following mild SARS CoV-2 infection: characteristic T cell 
alterations and response to antihistamines. medRxiv, 2021: p. 2021.06.06.21258272.
34. Echizen, H. and T. Ishizaki, Clinical pharmacokinetics of famotidine. Clin Pharmacokinet, 
1991. 21(3): p. 178-94.

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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28. Protocol Checklist
Please note that protocol sections with an asterisk (*) should always be included in the protocol; if the section does not 
have an asterisk, and you have not included the section in the protocol, the IRB will consider it your attestation that 
the section does not apply to your study.
Protocol Section
Added to 
the 
protocol?
External Collaborators- if applicable, add each external collaborator information and 
indicate whether that institution’s IRB will review (or has already reviewed) that individual’s 
engagement in human participants research activities)  
☒ Yes
Funding Source*: Include the information for the funding entity for this study.  Please 
explain if this study is covered by a sub-award or other pertinent information. Say 
“department” if you do not have any other funding.
☒ Yes
Objectives*: Describe the purpose, specific aims, or objectives and state the hypotheses to 
be tested
☒ Yes
Background*: Describe the relevant prior experience and gaps in current knowledge. 
Describe any relevant preliminary data. Provide the scientific or scholarly background for, 
the rationale for, and significance of the research based on the existing literature and how 
will it add to existing knowledge
☒ Yes
Study Endpoints*: Describe the primary and secondary study endpoints. Describe any 
primary or secondary safety endpoints. 
☒ Yes
Study Intervention/Investigational Agent*: Describe the study intervention and/or 
investigational agent (e.g., drug, device) that is being evaluated.  
☒ Yes
Drug/Device Handling: If the research involves drugs or devices, describe your plans to store,
handle, and administer those drugs or devices so that they will be used only on participants 
and be used only by authorized investigators.
If using a drug, explain if the control of the drug is managed by IDS (or VA/Grady/CHOA 
research pharmacies). If not, provide IDS exemption document.
If a device, explain how the device is being stored and managed.
☒ Yes
If the drug is under an FDA REMS, plan to complete the REMS checklist found here, on the 
IRB website.
☒ Yes

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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If the drug is considered a controlled substance, make sure you have filled out this form.
☒ Yes
If applicable, identify the holder of the IND/IDE/Abbreviated IDE. An Emory investigator who 
holds an IND or IDE is considered to be a Sponsor-Investigator (S-I). If the study is under an S-I, 
review this section of our website for additional requirements.
☒ Yes
Procedures involved*: Describe and explain the study design and include a study schema.  
Describe all research procedures being performed and when they are performed, including 
procedures being performed to monitor participants for safety or minimize risks
☒ Yes
Procedures-Minimizing risk*: describe the procedures performed to lessen the probability 
or magnitude of risks.
☒ Yes
Procedures- Drug/Device Use: describe all drugs and devices used in the research and the 
purpose of their use and their regulatory approval status
☒ Yes
Procedures-Source Records*: describe source records that will be used to collect data about 
participants. Attach all surveys, scripts, and data collection forms to the submission.
☒ Yes
Procedures-Data collection*: describe what data will be collected during the study and how 
that data will be obtained
☒ Yes
Procedures- Long Term Follow Up*: once all research-related procedures are complete, 
what data will be collected during this period.  If no data is collected after procedures are 
completed, please state in the submission.
☒ Yes
Data and Specimen Banking: describe where the specimens will be stored, how long they 
will be stored, how the specimens will be accessed, and who will have access to the 
specimens.  Depending on the volume and nature of the collection, this may require a 
separate repository-specific IRB submission. The VA Data Repository SOP is required if the 
study is creating a data repository at the Atlanta VA.
List the data to be stored or associated with each specimen.
Describe the procedures to release data or specimens, including the process to request a 
release, approvals required for release, who can obtain data or specimens, and the data to 
be provided with specimens.
☒ Yes

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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Sharing of Results with Participants*: Describe whether results (study results or individual 
subject results, such as results of investigational diagnostic tests, genetic tests, or incidental 
findings) will be shared with participants or others (e.g., the participant’s primary care 
physicians) and if so, describe how the results will be shared If applicable (e.g. for studies 
involving scans and/or panels of exploratory testing on specimens)
Plan for managing the types of findings that might arise. This should include any secondary 
findings that are being sought actively, findings that might be anticipatable, and findings 
that might be un-anticipatable. 
Plan for recognizing, analyzing, and handling incidental findings and how incidental findings 
will be communicated to participants during the consent process. If the plan is not to 
disclose any findings, then this should be included. This plan might include the option for 
participants to opt-out of receiving incidental findings.
Description of the research team’s responsibilities following disclosure of a finding. This 
should detail educational information about the nature of the finding, how to seek care 
from a clinician or specialist, obtaining health insurance to secure treatment, and/or referral 
to a clinical specialist, if one is required. 
Reminder to include language in the consent form to let the participants know your plans 
for this – see Modular Language for Informed Consent Forms on IRB website)
☒ Yes
Study timelines*: describe the duration of an individual participant’s participation in the 
study; anticipated time to enroll all study participants and the estimated date for the 
investigators to complete this study (complete primary analyses)
☒ Yes
Inclusion and Exclusion Criteria*: describe how individuals will be screened for eligibility 
and the criteria that define who will be included or excluded in your final study sample 
☒ Yes
Population*: describe the study population and indicate specifically whether you will 
include or exclude each of the following special populations: 

Adults unable to consent

Individuals who are not yet adults (infants, children, teenagers)

Pregnant women

Prisoners
Note: you cannot exclude people with limited English proficiency unless you can 
demonstrate the scientific need for such exclusion.
Community Participation: For studies aimed at addressing issues that affect a certain 
community or group: How, if at all, will this study involve people from the target community 
☒ Yes

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
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in the design of the study? Conduct of the study? How will the results of the research be 
shared with the participants and/or the target community/ies?  
If studying Race or Ethnicity, have you defined these terms, and explained their proposed 
mechanism of action if these characteristics will be used in an explanatory model?
Research with pregnant women, fetuses, or neonates: review this checklist to verify you 
have provided enough information to ensure the safety and well-being of this population.
☒ Yes
Research with neonates of uncertain viability: review this checklist to verify you have 
provided enough information to ensure the safety and well-being of this population.
☒ Yes
Research involving prisoners: review this checklist to verify you have provided enough 
information to ensure the safety and well-being of this population.
☒ Yes
Research involving children: review this checklist to verify you have provided enough 
information to ensure the safety and well-being of this population.
☒ Yes
Research involving cognitively impaired adults: review this checklist to verify you have 
provided enough information to ensure the safety and well-being of this population.
☒ Yes
Research involving economically or educationally disadvantaged persons: describe the 
additional safeguards that have been included in the study to protect the rights and welfare 
of these subjects
☒ Yes
Local Number of Participants*: Indicate the total number of participants to be accrued 
locally. If applicable, distinguish between the number of participants who are expected to 
be enrolled and screened, and the number of participants needed to complete the research 
procedures (i.e., numbers of participants excluding screen failures.) 
Provide your projected enrolling goals, including the percentage of participants according to 
sex and race.   
☒ Yes
Recruitment Methods*: Describe when, where, and how potential participants will be 
recruited.  Describe the source of participants. Describe the methods that will be used to 
☒ Yes

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
Page 42 of 49
 
Version: 2.0_20Nov 2023
IRB Form BIO 01192022
identify potential participants.  Describe materials that will be used to recruit participants. 
Attach copies of these documents with the application. 
If including advertisements, attach the final copy of them. When advertisements are taped 
for broadcast, attach the final audio/videotape. You may submit the wording of the 
advertisement before taping to preclude re-taping because of inappropriate wording, 
provided the IRB reviews the final audio/videotape. Describe the amount and timing of any 
payments to participants. Reimbursement for expenses/travel?
If using contests or raffles as incentive, you must offer entry to all potential participants, not 
just those who enroll in the study/complete study-related procedures, per Georgia State 
Law.
All research recruitment through social media needs to follow this guidance, which does not 
allow the use of personal social media accounts for some recruitment activities.
Withdrawal of Participants*: Describe anticipated circumstances under which participants 
will be withdrawn from the research without their consent. Describe any procedures for 
orderly termination. Describe procedures that will be followed when participants withdraw 
from the research, including partial withdrawal from procedures with continued data 
collection.
☒ Yes
Risk to Participants*: List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the participants related to the participant's participation in the research. 
Include as may be useful for the IRB’s consideration, a description of the probability, 
magnitude, duration, and reversibility of the risks. Consider physical, psychological, social, 
legal, and economic risks.
If applicable, indicate which procedures may have risks to the participants that are currently 
unforeseeable.
If applicable, indicate which procedures may have risks to an embryo or fetus should the 
subject be or become pregnant.
If applicable, describe risks to others who are not participants.
☒ Yes
Potential Benefits to Participants*: Describe the potential benefits that individual 
participants may experience from taking part in the research. Include as may be useful for 
the IRB’s consideration, the probability, magnitude, and duration of the potential benefits.
Indicate if there is no direct benefit. Do not include benefits to society or others.
☒ Yes
Compensation to Participants*: Describe if/how subjects will be compensated for 
participation in this study. Indicate what method compensation will be delivered (e.g. cash, 
gift card, school credit). Describe the amount and timing of any payments to participants.  
☒ Yes

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
Page 43 of 49
 
Version: 2.0_20Nov 2023
IRB Form BIO 01192022
How much?  What kind?  Is tax information required? (if so, must be reflected in the 
informed consent form). Will payments be pro-rated if a participant withdraws early?
Data Management and Confidentiality*: Describe the data analysis plan, including any 
statistical procedures or power analysis. Describe the steps that will be taken to secure the 
data (e.g., training, authorization of access, password protection, encryption, physical 
controls, certificates of confidentiality, and separation of identifiers and data) during 
storage, use, and transmission. Describe any procedures that will be used for the quality 
control of collected data. 
☒ Yes
Describe how data or specimens will be handled study-wide*: What information will be 
included in that data or associated with the specimens?
•
Where and how data or specimens will be stored?
•
How long the data or specimens will be stored?
•
Who will have access to the data or specimens?
•
Who is responsible for receipt or transmission of the data or specimens?
•
How data or specimens will be transported?
☒ Yes
Data Monitoring and Participants Safety (if this study is more than minimal risk, this 
section is required): 
Ensure that you review our Data and Safety Monitoring plan guidance for specific details 
about this section, and examples of what the IRB will be requiring according to the level of 
risk.
If a DSMB is needed, please describe the composition of the board (if not already detailed 
in the protocol).  Review this guidance for more information.  If the sponsor protocol does 
not contain all required information, please in this section. 
Describe the plan to periodically monitor the data at the site level according to risk level. 
Include the appropriate completed monitoring table, if applicable. 
Description of the plan for notifying the IRB of reportable events, whether the sponsor 
requires reporting above and beyond the Emory IRB reporting requirements, and if so, a 
description of the requirements and plan for meeting them. 
Please address the specific details below. If deemed not applicable, please provide 
rationale:
☒ Yes

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
Page 44 of 49
 
Version: 2.0_20Nov 2023
IRB Form BIO 01192022
Subject safety:

Specific subject safety parameters 

Frequency of subject safety observations

Individual responsible for safety monitoring

Subject stopping rules – under what conditions will a subject be removed from 
study participation and who will make the decision?

Study stopping rules - under what conditions will the study be modified or stopped 
and who will make the decision?

Reporting mechanisms (i.e. Deviations, adverse events, UPs)
Data Integrity:

Specific data elements to be reviewed

Frequency of monitoring data, points in time, or after a specific number of 
participants

Individual responsible for data monitoring
Additional considerations for FDA regulated trials 
Depending on the procedures affecting risks to participants, the site monitoring plan should 
specify:

Categorization of activities done centrally and those on-site if applicable

Monitoring methods (may include centralized/remote, on-site, and self-monitoring)

Reference to any tools used (i.e. checklists)

Identification of events that may trigger changes

Identification of deviations or failures that would be critical to study integrity
Provisions to Protect the Privacy Interests of Participants*: 

Describe the steps that will be taken to protect participants’ privacy interests. “Privacy 
interest” refers to a person’s desire to place limits on whom they interact with or whom 
they provide personal information.

Describe what steps you will take to make the participants feel at ease with the 
research situation in terms of the questions being asked and the procedures being 
performed. “At ease” does not refer to physical discomfort, but the sense of 
☒ Yes

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
Page 45 of 49
 
Version: 2.0_20Nov 2023
IRB Form BIO 01192022
intrusiveness a participant might experience in response to questions, examinations, 
and procedures.

Indicate how the research team is permitted to access any sources of information about 
the participants.
Economic Burden to Participants*: Describe any costs that participants may be responsible 
for because of participation in the research.
☒ Yes
Consent Process*: Describe where the consent process will take place, any waiting period 
available between informing the prospective subject and obtaining the consent; and the 
process to ensure ongoing consent.
Describe the role of the individuals listed in the application as being involved in the consent 
process; the time that will be devoted to the consent discussion; steps that will be taken to 
minimize the possibility of coercion or undue influence; and steps that will be taken to 
ensure the participants’ understanding.
Note: If you are planning to obtain consent via electronic signature, please review this 
document. Additional guidance on consent documentation and process can be found on our 
website, under the consent toolkit.
☒ Yes
Consent Process-Non-English-Speaking Participants*: 
Indicate what language(s) other than English are understood by prospective participants or 
representatives.
If participants who do not speak English will be enrolled, describe the process to ensure that 
the oral and written information provided to those participants will be in that language. 
Indicate the language that will be used by those obtaining consent.
If you checked N/A, please provide reasoning of why subjects with limited English 
proficiency are excluded. 
Note: if you stated that subjects with LEP will be enrolled, you are approved for the use of 
the Emory IRB short forms.  Please read the guidance about the use of short forms here.
☒ Yes
Consent Process-Children: After determining if the subject is a child per GA law (or if 
enrolled outside GA, per state/country law), please describe whether parental permission 
will be obtained from:

Both parents unless one parent is deceased, unknown, incompetent, or not reasonably 
available, or when only one parent has legal responsibility for the care and custody of 
the child.
☒ Yes

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
Page 46 of 49
 
Version: 2.0_20Nov 2023
IRB Form BIO 01192022

One parent even if the other parent is alive, known, competent, reasonably available, 
and shares legal responsibility for the care and custody of the child.
Describe whether permission will be obtained from individuals other than parents, and if so, 
who will be allowed to provide permission.  Describe the process used to determine these 
individuals’ authority to consent to each child’s general medical care.
When assent of children is obtained describe whether and how it will be documented per 
Emory Policies and Procedures
Consent Process-Cognitively Impaired Adults:  describe the process to determine whether 
an individual is capable of consent. The IRB allows the person obtaining assent to document 
assent on the consent document and does not routinely require assent documents and does 
not routinely require children to sign assent documents.
☒ Yes
Consent Process-Adults Unable to Consent:  List the individuals from whom permission will 
be obtained in the order of priority. (E.g., durable power of attorney for health care, a court-
appointed guardian for health care decisions, spouse, and adult child.)
For research conducted in the state, review “46 LEGALLY AUTHORIZED REPRESENTATIVES 
AND SURROGATE CONSENT” to be aware of which individuals in the state meet the 
definition of “legally authorized representative.”
For research conducted outside of the state, provide information that describes which 
individuals are authorized under applicable law to consent on behalf of a prospective 
subject to their participation in the procedure(s) involved in this research. 
Describe the process for the assent of the participants. Indicate whether:

Assent will be required of all, some, or none of the participants. If some, indicated, 
which participants will be required to assent and which will not.

If assent will not be obtained from some or all participants, an explanation of why not.
Describe whether the assent of the participants will be documented and the process to 
document assent. The IRB allows the person obtaining assent to document assent on the 
consent document and does not routinely require assent documents and does not routinely 
require participants to sign assent documents
☒ Yes
Waiver or Alteration of Consent Process (consent will not be obtained, required 
information will not be disclosed, or the research involves deception) 
☒ Yes

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
Page 47 of 49
 
Version: 2.0_20Nov 2023
IRB Form BIO 01192022
Review the Emory IRB waiver document to ensure you have provided sufficient information 
for the IRB to make these determinations.
If the research involves a waiver of the consent process for planned emergency research, 
please review the “CHECKLIST: Waiver of Consent for Emergency Research (HRP-419)” to 
ensure you have provided sufficient information for the IRB to make these determinations.
Setting*: Describe the sites or locations where your research team will conduct the research 
including where the subject will be identified and recruited, where the research procedures 
will be performed, and if you will involve a community advisory board.  For research 
conducted outside the organization and its affiliates describe the site-specific regulations or 
customs affecting the research outside the organization and the local scientific and ethical 
review structure outside the organization.
☒ Yes
Resources Available*: Describe the resources available to conduct the research such us the 
feasibility of recruiting the required number of suitable participants within the agreed 
recruitment period; describe the time that you will devote to conducting and completing 
the research; describe the availability of medical or psychological resources that participants 
might need as a result of an anticipated consequences of the human research; describe your 
process to ensure that all persons assisting with the research are adequately informed 
about the protocol, the research procedures, and their duties and functions.
☒ Yes
Multi-Site Research when Emory is the Lead Site:
Study -Wide Number of Participants: indicate the total number of participants to be accrued 
across all sites.
Study-Wide Recruitment Methods: If this is a multicenter study and participants will be 
recruited by methods not under the control of the local site (e.g., call centers, national 
advertisements) describe those methods.  
Describe when, where, and how potential participants will be recruited.
Describe the methods that will be used to identify potential participants.
Describe materials that will be used to recruit participants. 
Describe the processes to ensure communication among sites. See “WORKSHEET: 
Communication and Responsibilities (HRP-830).” All sites have the most current version of 
the protocol, consent document, and HIPAA authorization.
All required approvals (initial, continuing review and modifications) have been obtained at 
each site (including approval by the site’s IRB of record).
All modifications have been communicated to sites and approved (including approval by the 
site’s IRB of record) before the modification is implemented.
☒ Yes

Protocol Title: Treatment of Long COVID (TLC) Feasibility Trial: Feasibility Assessment of a 
Decentralized Platform Double-blind, Randomized, Controlled Trial Investigating Repurposed 
Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC) 
Page 48 of 49
 
Version: 2.0_20Nov 2023
IRB Form BIO 01192022
All engaged participating sites will safeguard data, including secure transmission of data, as 
required by local information security policies.
All local site investigators conduct the study in accordance with applicable federal 
regulations and local laws. 
All non-compliance with the study protocol or applicable requirements will reported in 
accordance with local policy
Describe the method for communicating to engaged participating sites (see “WORKSHEET: 
Communication and Responsibilities (HRP-830)”):

Problems (inclusive of reportable events).

Interim results.

The closure of a study
If this is a multicenter study where you are a participating site/investigator, describe the 
local procedures for maintenance of confidentiality. (See “WORKSHEET: Communication and 
Responsibilities (HRP-830).”)

Where and how data or specimens will be stored locally?

How long the data or specimens will be stored locally?

Who will have access to the data or specimens locally?

Who is responsible for receipt or transmission of the data or specimens locally?

How data and specimens will be transported locally?