Fenofibrate for Patients With COVID-19 Requiring Hospitalization

SARS-CoV-2 Infection Clinical Trial

— FENOC  

Official title:

A Study of a 10-days Fenofibrate Treatment, or Until Discharge From Hospital, Among COVID-19 Infected Patients Requiring Hospitalization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04661930
• Other study ID #: 0105-20-BRZ; FENOC-005
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: April 2022
• Source: Hebrew University of Jerusalem
• Contact: Yaakov Nahmias, PhD
• Phone: +972-2-5494640
• Email: ynahmias[@]cs.huji.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label run-in followed by a randomized, double-blind drug treatment study of COVID-19 infected patients requiring inpatient hospital admission.

Description:

This is an open-label run-in followed by a randomized, double-blind drug treatment study of COVID-19 infected patients requiring inpatient hospital admission. Open-label patients will be matched at least 1:10 with observational retrospective Propensity score-matched (PSM) patients' medical files. The double-blinded step will be randomized 2:1 to daily Fenofibrate or placebo for 10 days or hospital discharge.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: July 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Presumptive positive laboratory test for SARS-CoV-2 based on local laboratory standard

• Age greater than or equal to 18 years of age

• Severe COVID-19, defined by:

• A disease severity score of 3 (Hospitalized, on non-invasive ventilation or high flow oxygen devices) to 4 (Hospitalized, requiring supplemental oxygen).

AND o A respiratory SOFA >=1 and increased oxygen requirement compared to baseline among those on home O2, a blood oxygen saturation of 93% or less on room air, a ratio of the partial pressure of oxygen to the fraction of inspired oxygen (PaO2/FiO2) of less than 300 mm Hg, respiratory rate >30 breaths/min, or lung infiltrates >50% on chest CT

• Enrollment within 72 hours of presentation of hospital admission or within 72 hours of a positive test result, whichever is later

Exclusion Criteria:

• Enrollment > 72 hours of admission order or positive test result, whichever is later

• Admission to the hospital with a respiratory SOFA >=5 , Critical COVID-19, or Disease Severity Score >5 (requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or all)

• Known hypersensitivity to fenofibrate

• For female subjects:

1. Pregenant, determined by a human chorionic gonadotropin (HCG) rapid detection kit or a blood test

2. Breastfeeding

3. Undergoing fertility treatments

• Patient-reported history or electronic medical record history of kidney disease, defined as:

1. Any history of dialysis

2. History of chronic kidney disease stage IV

3. Estimated Glomerular Filtration Rate (eGFR) of < 30ml/min/1.73 m2 at the time of enrollment

• Acute pre-renal azotemia at the time of enrollment in the opinion of the investigator or bedside clinician

• Most recent mean arterial blood pressure prior to enrollment <65 mmHg

• Patient-reported history or electronic medical record history of severe liver disease, defined as:

1. Cirrhosis

2. History of hepatitis B or C

3. Documented AST or ALT > 10 times the upper limit of normal measured within 24 hours prior to enrollment

• Patient-reported history or electronic medical record history of gallbladder disease

• Potassium >5.0 within 24 hours prior to enrollment unless a repeat value was <=5.0

• Treatment with coumarin anticoagulants (e.g., Warfarin), immunosuppressants (e.g. cisplatin), bile acid resins, or sulfonylurea.

• Inability to obtain informed consent from participant or legally authorized representative

• Enrollment in another blinded randomized clinical trial for COVID

Related Conditions & MeSH terms

• Corona Virus Disease (COVID-19)
• COVID-19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• SARS-CoV-2 Infection
• Virus Diseases

Intervention

Drug:
• TriCor® 145mg tablets
Fenofibrate; 145 mg daily (1/day); oral administration; 10 days

Other:
• Placebo
Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration
• Usual care
All participants will otherwise receive usual medical care

Locations

Country	Name	City	State
Israel	Barzilai Medical Center	Ashkelon
Israel	Rambam Health Care Campus	Haifa
Israel	Nazareth Hospital EMMS	Nazareth

Sponsors (4)

Lead Sponsor	Collaborator
Yaakov Nahmias	Barzilai Medical Center, Nazareth Hospital, Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

References & Publications (8)

Bornstein SR, Dalan R, Hopkins D, Mingrone G, Boehm BO. Endocrine and metabolic link to coronavirus infection. Nat Rev Endocrinol. 2020 Jun;16(6):297-298. doi: 10.1038/s41574-020-0353-9. — View Citation

Ehrlich, A., Uhl, S., Ioannidis, K., Hofree, M., tenOever, B., and Nahmias, Y. (2020). The SARS-CoV-2 Transcriptional Metabolic Signature in Lung Epithelium. SSRN Electronic Journal.

McBride CE, Machamer CE. Palmitoylation of SARS-CoV S protein is necessary for partitioning into detergent-resistant membranes and cell-cell fusion but not interaction with M protein. Virology. 2010 Sep 15;405(1):139-48. doi: 10.1016/j.virol.2010.05.031. Epub 2010 Jul 1. — View Citation

Wu Q, Zhou L, Sun X, Yan Z, Hu C, Wu J, Xu L, Li X, Liu H, Yin P, Li K, Zhao J, Li Y, Wang X, Li Y, Zhang Q, Xu G, Chen H. Altered Lipid Metabolism in Recovered SARS Patients Twelve Years after Infection. Sci Rep. 2017 Aug 22;7(1):9110. doi: 10.1038/s41598-017-09536-z. — View Citation

Yan B, Chu H, Yang D, Sze KH, Lai PM, Yuan S, Shuai H, Wang Y, Kao RY, Chan JF, Yuen KY. Characterization of the Lipidomic Profile of Human Coronavirus-Infected Cells: Implications for Lipid Metabolism Remodeling upon Coronavirus Replication. Viruses. 2019 Jan 16;11(1). pii: E73. doi: 10.3390/v11010073. — View Citation

Yang JK, Lin SS, Ji XJ, Guo LM. Binding of SARS coronavirus to its receptor damages islets and causes acute diabetes. Acta Diabetol. 2010 Sep;47(3):193-9. doi: 10.1007/s00592-009-0109-4. Epub 2009 Mar 31. — View Citation

Yuan S, Chu H, Chan JF, Ye ZW, Wen L, Yan B, Lai PM, Tee KM, Huang J, Chen D, Li C, Zhao X, Yang D, Chiu MC, Yip C, Poon VK, Chan CC, Sze KH, Zhou J, Chan IH, Kok KH, To KK, Kao RY, Lau JY, Jin DY, Perlman S, Yuen KY. SREBP-dependent lipidomic reprogramming as a broad-spectrum antiviral target. Nat Commun. 2019 Jan 10;10(1):120. doi: 10.1038/s41467-018-08015-x. — View Citation

Zhu L, She ZG, Cheng X, Qin JJ, Zhang XJ, Cai J, Lei F, Wang H, Xie J, Wang W, Li H, Zhang P, Song X, Chen X, Xiang M, Zhang C, Bai L, Xiang D, Chen MM, Liu Y, Yan Y, Liu M, Mao W, Zou J, Liu L, Chen G, Luo P, Xiao B, Zhang C, Zhang Z, Lu Z, Wang J, Lu H, Xia X, Wang D, Liao X, Peng G, Ye P, Yang J, Yuan Y, Huang X, Guo J, Zhang BH, Li H. Association of Blood Glucose Control and Outcomes in Patients with COVID-19 and Pre-existing Type 2 Diabetes. Cell Metab. 2020 Jun 2;31(6):1068-1077.e3. doi: 10.1016/j.cmet.2020.04.021. Epub 2020 May 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Significant post-acute incident diagnoses after recovery at 28-days	Incident rate per 1000 at 28-days in hospitalized COVID-19 is ascertained from hospital admission until 28-days or end of follow-up.	1 day
Other	Significant post-acute incident diagnoses after recovery at 90-days	Incident rate per 1000 at 90-days in hospitalized COVID-19 is ascertained from hospital admission until 90-days or end of follow-up.	1 day
Other	Significant post-acute incident diagnoses after recovery at 6-months	Incident rate per 1000 at 6-months in hospitalized COVID-19 is ascertained from hospital admission until 6-months or end of follow-up.	1 day
Primary	Number of Therapeutic Oxygen-Free Days	Outcome reported as the mean number of days participants in each arm did not require therapeutic oxygen usage during an in-patient hospital admission.	14 days
Primary	Length of Hospital Stay	Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm	14 days
Primary	Viral Clearance by Nasopharyngeal Swab	Nasopharyngeal swabs will be collected every second day for the duration of study participation. Viral clearance is measured as fold change in viral genetic copies per mL	14 days
Primary	Difference in Estimated P/F Ratio at 14 days	Outcome calculated from the partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry divided by the fraction of inspired oxygen (PaO2 or SaO2 : FiO2 ratio). PaO2 is preferentially used if available.	14 days
Primary	Difference in Plasma Neutrophils at 14 days	Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.	14 days
Primary	Difference in Plasma Lymphocytes at 14 days	Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.	14 days
Primary	Difference in Plasma Monocytes at 14 days	Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.	14 days
Primary	Difference in Plasma C-Reactive Protein (CRP) at 14 days	Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.	14 days
Primary	Difference in Plasma IL-6 at 14 days	Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.	14 days
Primary	Difference in Plasma Procalcitonin (PCT) at 14 days	Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.	14 days
Primary	Difference in Plasma Ferritin at 14 days	Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.	14 days
Primary	Difference in NLR (Neutrophils to Lymphocytes Ratio) at 14 days	Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.	14 days
Secondary	14-Day Mortality	Outcome reported as the number of participants who have expired at 14 days post enrollment.	14 days
Secondary	Difference in Organ Injury Plasma markers at 14 days - Lactate	Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.	14 days
Secondary	Difference in Organ Injury Plasma markers at 14 days - Cardiac Troponin (TRO)	Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.	14 days
Secondary	Difference in Organ Injury Plasma markers at 14 days - Creatine Kinase (CK)	Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.	14 days
Secondary	Difference in Organ Injury Plasma markers at 14 days - Alanine Aminotransferase (ALT)	Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.	14 days
Secondary	Difference in Organ Injury Plasma markers at 14 days - Alkaline Phosphatase (ALP)	Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.	14 days
Secondary	Difference in Organ Injury Plasma markers at 14 days - D-dimer	Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.	14 days
Secondary	Difference in Organ Injury Plasma markers at 14 days - Platelets (PLT)	Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.	14 days
Secondary	Number of Abnormal Biomarker Days - D-dimer	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	14 days
Secondary	Number of Abnormal Biomarker Days - Neutrophils	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	14 days
Secondary	Number of Abnormal Biomarker Days - Lymphocytes	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	14 days
Secondary	Number of Abnormal Biomarker Days - Platelets (PLT)	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	14 days
Secondary	Number of Abnormal Biomarker Days - Monocytes	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	14 days
Secondary	Number of Abnormal Biomarker Days - C-Reactive Protein (CRP)	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	14 days
Secondary	Number of Abnormal Biomarker Days - IL-6	Outcome reported as the mean number of days participants in each arm had 2 or more abnormal plasma levels.	14 days
Secondary	Number of Abnormal Biomarker Days - Procalcitonin (PCT)	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	14 days
Secondary	Number of Abnormal Biomarker Days - Lactate	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	14 days
Secondary	Number of Abnormal Biomarker Days - Cardiac Troponin (TRO)	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	14 days
Secondary	Number of Abnormal Biomarker Days - Creatine Kinase (CK)	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	14 days
Secondary	Number of Abnormal Biomarker Days - Alanine Aminotransferase (ALT)	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	14 days
Secondary	Number of Abnormal Biomarker Days - Alkaline Phosphatase (ALP)	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	14 days
Secondary	Number of Abnormal Biomarker Days - Ferritin	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	14 days
Secondary	Difference in Oxygenation at 14 days	PaO2 or SaO2 and FiO2. Partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry. FiO2 is estimated from oxygen flow/delivery rates	14 days
Secondary	Difference in Estimated PEEP adjusted P/F Ratio at 14 days	Outcome calculated from the partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry divided by the fraction of inspired oxygen (PaO2 or SaO2 : FiO2 ratio) and Expiratory Pressure.	14 days
Secondary	Daily Hypotensive Episodes	Outcome reported as the mean number of daily hypotensive episodes (MAP < 65 mmHg) prompting intervention (indicated by a fluid bolus >=500 mL, new treatment with pressures, increase in 50% pressure or fluid rate) per participant in each arm.	14 days
Secondary	Hypotension Requiring Vasopressors	Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.	14 days
Secondary	Acute Kidney Injury	Outcome reported as the number of participants in each arm who experience acute kidney injury as defined by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines: Increase in serum creatinine by 0.3mg/dL or more within 48 hours OR Increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR Urine output less than 0.5 mL/kg/h for 6 hours.	14 days
Secondary	Sequential Organ Failure Assessment (SOFA) Total Score	The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total score is calculated by entering patient data into a SOFA calculator, a widely available software. Total scores range from 0-24, with higher scores indicating greater risk of mortality.	14 days
Secondary	Oxygen Saturation / Fractional Inhaled Oxygen (F/S)	Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless.	14 days
Secondary	28-Day Mortality	Outcome reported as the number of participants who have expired at 28 days post enrollment.	28 days
Secondary	90-Day Mortality	Outcome reported as the number of participants who have expired at 90 days post enrollment.	90 days
Secondary	ICU Admission	Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).	14 days
Secondary	Number of Ventilator-Free Days	Outcome reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.	14 days
Secondary	Number of Vasopressor-Free Days	Outcome reported as the mean number of days participants in each arm did not require vasopressor usage during an in-patient hospital admission.	14 days
Secondary	Length of ICU Stay	Outcome reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.	14 days
Secondary	Incidence of Respiratory Failure	Outcome reported as the number of participants requiring BiPAP OR high flow nasal cannula OR mechanical ventilation OR extracorporeal membranous oxygenation (ECMO) utilization during in-patient hospital care in each arm.	14 days
Secondary	Change in PROMIS Dyspnea Functional Limitations	The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. In the 33-item Functional Limitations bank, 33 daily activities are rated in terms of degree of difficulty while engaging in the activity over the past 7 days (0 = no difficulty, 1 = a little difficulty, 2 = some difficulty, 3 = much difficulty). Total scores range from 0 to 99, with higher scores reflecting greater functional limitations.	14 days
Secondary	Change in PROMIS Dyspnea Severity	The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. The 33-item Severity bank assesses the severity of difficulty breathing during various specific activities (the same 33 activities assessed in Dyspnea Functional Limitations). Each activity is rated in terms of degree of dyspnea (0 = no shortness of breath, 1 = mildly short of breath, 2 = moderately short of breath, 3 = severely short of breath) while engaging in the activity over the past 7 days. Total scores range from 0 to 99 with higher scores reflecting greater levels of dyspnea during daily activity.	14 days
Secondary	Disease Severity Rating	Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.	14 days
Secondary	Viral Load by Nasopharyngeal Swab	Nasopharyngeal swabs will be collected every fourth day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.	14 days
Secondary	Viral Load by Blood	Blood will be collected every third day for viral load assessment for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.	14 days
Secondary	Viral Clearance by Blood	Blood will be collected every third day for viral load assessment for the duration of study participation. clearance is measured as fold change in viral genetic copies per mL.	14 days
Secondary	Abnormal Biomarkers after recovery - D-dimer	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	1 day
Secondary	Abnormal Biomarkers after recovery - Neutrophils	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	1 day
Secondary	Abnormal Biomarkers after recovery - Lymphocytes	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	1 day
Secondary	Abnormal Biomarkers after recovery - Platelets (PLT)	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	1 day
Secondary	Abnormal Biomarkers after recovery - Monocytes	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	1 day
Secondary	Abnormal Biomarkers after recovery - C-Reactive Protein (CRP)	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	1 day
Secondary	Abnormal Biomarkers after recovery - IL-6	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	1 day
Secondary	Abnormal Biomarkers after recovery - Procalcitonin (PCT)	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	1 day
Secondary	Abnormal Biomarkers after recovery - Lactate	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	1 day
Secondary	Abnormal Biomarkers after recovery - Cardiac Troponin (TRO)	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	1 day
Secondary	Abnormal Biomarkers after recovery - Creatine Kinase (CK)	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	1 day
Secondary	Abnormal Biomarkers after recovery - Alanine Aminotransferase (ALT)	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	1 day
Secondary	Abnormal Biomarkers after recovery - Alkaline Phosphatase (ALP)	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	1 day
Secondary	Abnormal Biomarkers after recovery - Ferritin	Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.	1 day
Secondary	Abnormal Oxygenation after recovery	Outcome reported as the mean number of participants in each arm had abnormal PaO2 or SaO2 and FiO2 levels at the end of quarantine period. Partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry. FiO2 is estimated from oxygen flow/delivery rates	1 day
Secondary	PROMIS Dyspnea Functional Limitations after recovery	The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. In the 33-item Functional Limitations bank, 33 daily activities are rated in terms of degree of difficulty while engaging in the activity over the past 7 days (0 = no difficulty, 1 = a little difficulty, 2 = some difficulty, 3 = much difficulty). Total scores range from 0 to 99, with higher scores reflecting greater functional limitations. Measured at the end of quarantine period.	1 day
Secondary	PROMIS Dyspnea Severity after recovery	The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. The 33-item Severity bank assesses the severity of difficulty breathing during various specific activities (the same 33 activities assessed in Dyspnea Functional Limitations). Each activity is rated in terms of degree of dyspnea (0 = no shortness of breath, 1 = mildly short of breath, 2 = moderately short of breath, 3 = severely short of breath) while engaging in the activity over the past 7 days. Total scores range from 0 to 99 with higher scores reflecting greater levels of dyspnea during daily activity. Measured at the end of quarantine period.	1 day