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imPROving Quality of LIFe In the Long COVID Patient (PROLIFIC)

Primary Purpose

Post-COVID-19 Syndrome, Long COVID, Long Covid19

Status
Recruiting
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Nirmatrelvir/ritonavir
Placebo/ritonavir
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-COVID-19 Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The subject has given written consent to participate in the study. ≥18 years of age at the time of the Screening Visit. Post-acute COVID-19 syndrome (PACS) according to the WHO definition. EQ-5D-5L VAS< 50 All fertile participants must agree to use a highly effective method of contraception for the duration of the study and 28 days after last intake of the IMP. Exclusion Criteria: General exclusion criteria Other non-related conditions with PACS like symptoms. Renal function eGFR eGFRCysC < 60 mL/min/1.73 m2. Not able to comply with the study protocol. Previous Paxlovid treatment. Pregnancy or breastfeeding. Drug-drug interaction with ongoing treatment, including concomitant use of any medications or substances that are strong inducers of CYP3A4 within 28 days prior to first dose of nirmatrelvir/ritonavir and during study treatment. Participants who are planning or considering vaccination (including boosters) through Study Day 45. Active COVID-19 infection as verified by SARS CoV-2 positive antigen test. Self-reported medical conditions, including: Type 1 or Type 2 diabetes mellitus. Chronic kidney disease. Neurodevelopmental disorders (e.g., cerebral palsy, Down's syndrome) or other conditions that confer medical complexity (e.g., genetic or metabolic syndromes and severe congenital anomalies). Active cancer other than localized skin cancer, including those requiring treatment including palliative treatment), as long as the treatment is not among the prohibited medications that must be administered/continued during the trial period. Immunosuppressive disease (e.g., bone marrow or organ transplantation or primary immune deficiencies) OR prolonged use of immune-weakening medications: i. Has received corticosteroids equivalent to prednisone ≥20 mg daily for at least 14 consecutive days within 30 days prior to study entry. ii. Has received treatment with biologics (e.g., infliximab, ustekinumab, etc.), immunomodulators (e.g., methotrexate, 6MP, azathioprine, etc.), or cancer chemotherapy within 90 days prior to study entry. iii. HIV infection with CD4+ cell count <200/mm3. History of hospitalization for the medical treatment of acute COVID-19 Current need for hospitalization or anticipated need for hospitalization within 48 hours after randomization in the clinical opinion of the site investigator. Prior/Concomitant Therapy: Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance, and for which elevated plasma concentrations may be associated with serious and/or life-threatening events during treatment and for 4 days after the last dose of nirmatrelvir/ritonavir. List of potential interactions provided by Pfizer provided in Appendix A. Has received or is expected to receive monoclonal antibody treatment, antiviral treatment (e.g., molnupiravir), or convalescent COVID-19 plasma. Prior/Concurrent Clinical Study Experience: Is unwilling to abstain from participating in another interventional clinical study with an investigational compound or device, including those for post-COVID-19 therapeutics, through the long-term follow-up visit. Previous administration with any investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Known prior participation in this trial or other trial involving nirmatrelvir. Diagnostic Assessments: Known history of any of the following abnormalities in clinical laboratory tests (within past 6 months of the screening visit): AST or ALT level ≥2.5 X ULN Total bilirubin ≥2 X ULN (≥3 X ULN for Gilbert's syndrome)

Sites / Locations

  • Karolinska InstitutetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nirmatrelvir/ritonavir

Placebo/ritonavir

Arm Description

Oral nirmatrelvir/ritonavir (Paxlovid) 300/100 mg twice daily for 15 days

Oral placebo/ritonavir 100 mg twice daily for 15 days

Outcomes

Primary Outcome Measures

Change from baseline in quality of life at day 16
The effect of oral administration of nirmatrelvir/ritonavir on quality of life measured as change from baseline using the EQ-5D-5L VAS scale.

Secondary Outcome Measures

Change from baseline in quality of life at days 45 and 90
The effect of oral administration of nirmatrelvir/ritonavir on quality of life measured as change from baseline using the EQ-5D-5L VAS scale.
Change from baseline in hemodynamic response at days 45 and 90
The effect of oral administration of nirmatrelvir/ritonavir on hemodynamic response (only patients diagnosed with postural orthostatic tachycardia syndrome, POTS). Change from baseline in delta maximum heart rate during active standing test.
Change from baseline in fever in patients with POTS at days 45 and 90
The effect of oral administration of nirmatrelvir/ritonavir on fever (only patients diagnosed with POTS). Change from baseline in POTS-specific symptoms as measured by using the Malmo POTS score, MAPS.
Change from baseline in endothelial function at day 45
The effect of oral administration of nirmatrelvir/ritonavir on reactive hyperemia index. Change from baseline in endothelial function measured using the EndoPat® device.
Change from baseline in heart rate at days 45 and 90
The effect of oral administration of nirmatrelvir/ritonavir on 24-h average heart rate. Change from baseline in heart rate using ECG monitoring device.
Change from baseline in fever at days 16, 45 and 90
The effect of oral administration of nirmatrelvir/ritonavir on fever. Change from baseline in body temperature.
Change from baseline in physical capacity at days 16, 45 and 90
The effect of oral administration of nirmatrelvir/ritonavir on physical capacity. Change from baseline as measured by 6-minute walk test.
Change from baseline in handgrip strength at days 16, 45 and 90
The effect of oral administration of nirmatrelvir/ritonavir on handgrip strength. Change from baseline as measured by JAMAR hand dynamometer.
Change from baseline in physical activity at days 16, 45 and 90
The effect of oral administration of nirmatrelvir/ritonavir on physical activity. Change from baseline as measured by accelerometer.
Change from baseline in post-exertional malaise at day 90
The effect of oral administration of nirmatrelvir/ritonavir on post-exertional malaise. Change from baseline in total score as measured by the Post-Exertional Malaise (PEM) short form.
Change from baseline in fatigue at days 16, 45 and 90
The effect of oral administration of nirmatrelvir/ritonavir on fatigue. Change from baseline as measured by the fatigue severity scale (FSS) and mental fatigue scale (MFS).
Change from baseline in cognitive dysfunction at days 16, 45 and 90
The effect of oral administration of nirmatrelvir/ritonavir on cognitive dysfunction. Change from baseline over time as measured by the Montreal Cognitive Assessment (MoCA) test.
Change from baseline in dyspnea at days 16, 45 and 90
The effect of oral administration of nirmatrelvir/ritonavir on dyspnea measured as change from baseline in respiratory symptoms using the Chronic obstructive disease assessment (CAT) and Modified Medical Research Council (mMRC) tests.
Change from baseline in dysfunctional breathing patterns, maximum inspiratory pressure and lung function at days 16, 45 and 90
The effect of oral administration of nirmatrelvir/ritonavir on dysfunctional breathing patterns, maximum inspiratory pressure, and lung function. Change from baseline in Njimegen questionnaire, maximal inspiratory pressure (MIP), forced vital capacity (FVC) and forced expiratory volume in one second (FEV1).
Change from baseline in plasma biomarkers at days 16, 45 and 90
The effect of oral administration of nirmatrelvir/ritonavir on plasma biomarkers. Change from baseline in the following plasma biomarkers: D-dimer, CRP, ESR, ferritin, NTproBNP and LD.
Change from baseline in dysautonomia at days 45 and 90
The effect of oral administration of nirmatrelvir/ritonavir on dysautonomia symptoms. Change from baseline as measured using the Composite Autonomic Symptom Score (Compass31) questionnaire.

Full Information

First Posted
April 20, 2023
Last Updated
June 22, 2023
Sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital, Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05823896
Brief Title
imPROving Quality of LIFe In the Long COVID Patient
Acronym
PROLIFIC
Official Title
An Interventional, Double-Blinded, 2-Arm Study to Investigate the Efficacy of Orally Administered Nirmatrelvir/Ritonavir Compared With Placebo/Ritonavir in Non-hospitalized Adult Participants Suffering From Post-COVID
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital, Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the efficacy of orally administered nirmatrelvir/ritonavir compared with placebo/ritonavir to improve quality of life in non-hospitalized adult participants suffering from post-acute COVID-19 syndrome.
Detailed Description
At present there is no curative treatment for post-acute COVID-19 syndrome (PACS). Treatment is focused on symptom management and individualized rehabilitation. There is data indicating SARS-CoV-2 viral persistence and chronic immune system activation in PACS. We are proposing an interventional, randomized and placebo-controlled clinical intervention trial of nirmatrelvir/ritonavir (300/100 mg) or placebo/ritonavir (100mg), twice daily for 15 days, in patients suffering from severe PACS. Patients meeting the WHO definition of severe PACS will be identified from a database of 988 patients cared for by the Karolinska University Hospital Post-COVID clinics since May 2020, and in whom extensive clinical and laboratory examinations have been performed. A total of 400 patients will be enrolled in this study and these will be randomized in a 2:1 ratio to receive either nirmatrelvir/ritonavir or placebo/ritonavir. The study will include deep exploratory systems-level analyses of the immune system in PACS patients, including changes induced by nirmatrelvir/ritonavir (Paxlovid®) treatment. The purpose of this study is to evaluate the efficacy of nirmatrelvir/ritonavir for its potential ability to provide sustained improvement in quality of life, in non-hospitalized patients with post-COVID, a patient group with high unmet medical needs. Hypothesis: Nirmatrelvir/ritonavir (Paxlovid®) improves health-related quality of life measured using the EQ-5D-5L VAS scale, as compared to placebo/ritonavir, in objective and pre-defined clinical phenotypes: postural orthostatic tachycardia syndrome (POTS), microvascular dysfunction, inappropriate sinus tachycardia, persistent fever, post exertional malaise (PEM), fatigue, brain fog, dyspnea, dysfunctional breathing patterns or inflammatory phenotypes (increased plasma D-dimer, CRP, ESR and ferritin).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-COVID-19 Syndrome, Long COVID, Long Covid19, COVID-19, POTS - Postural Orthostatic Tachycardia Syndrome, Post COVID-19 Condition, Post-COVID Syndrome, Post COVID-19 Condition, Unspecified, Postinfectious Inflammation, Postinfectious Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This is a phase II, interventional, randomized, parallel group, double-blind, placebo-controlled, single-center study of nirmatrelvir/ritonavir (300/100 mg) or placebo/ritonavir (100mg), administered orally twice daily for 15 days in non-hospitalized patients with post- COVID conditions.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nirmatrelvir/ritonavir
Arm Type
Active Comparator
Arm Description
Oral nirmatrelvir/ritonavir (Paxlovid) 300/100 mg twice daily for 15 days
Arm Title
Placebo/ritonavir
Arm Type
Placebo Comparator
Arm Description
Oral placebo/ritonavir 100 mg twice daily for 15 days
Intervention Type
Drug
Intervention Name(s)
Nirmatrelvir/ritonavir
Other Intervention Name(s)
Paxlovid
Intervention Description
300/100 mg tablet twice daily (q12h) administered orally for 15 days
Intervention Type
Drug
Intervention Name(s)
Placebo/ritonavir
Other Intervention Name(s)
Placebo
Intervention Description
100mg tablet twice daily (q12h) administered orally for 15 days
Primary Outcome Measure Information:
Title
Change from baseline in quality of life at day 16
Description
The effect of oral administration of nirmatrelvir/ritonavir on quality of life measured as change from baseline using the EQ-5D-5L VAS scale.
Time Frame
Baseline and day 16
Secondary Outcome Measure Information:
Title
Change from baseline in quality of life at days 45 and 90
Description
The effect of oral administration of nirmatrelvir/ritonavir on quality of life measured as change from baseline using the EQ-5D-5L VAS scale.
Time Frame
Baseline and days 45 and 90
Title
Change from baseline in hemodynamic response at days 45 and 90
Description
The effect of oral administration of nirmatrelvir/ritonavir on hemodynamic response (only patients diagnosed with postural orthostatic tachycardia syndrome, POTS). Change from baseline in delta maximum heart rate during active standing test.
Time Frame
Baseline and days 45 and 90
Title
Change from baseline in fever in patients with POTS at days 45 and 90
Description
The effect of oral administration of nirmatrelvir/ritonavir on fever (only patients diagnosed with POTS). Change from baseline in POTS-specific symptoms as measured by using the Malmo POTS score, MAPS.
Time Frame
Baseline and days 45 and 90
Title
Change from baseline in endothelial function at day 45
Description
The effect of oral administration of nirmatrelvir/ritonavir on reactive hyperemia index. Change from baseline in endothelial function measured using the EndoPat® device.
Time Frame
Baseline and day 45
Title
Change from baseline in heart rate at days 45 and 90
Description
The effect of oral administration of nirmatrelvir/ritonavir on 24-h average heart rate. Change from baseline in heart rate using ECG monitoring device.
Time Frame
Baseline and days 45 and 90
Title
Change from baseline in fever at days 16, 45 and 90
Description
The effect of oral administration of nirmatrelvir/ritonavir on fever. Change from baseline in body temperature.
Time Frame
Baseline and days 16, 45 and 90
Title
Change from baseline in physical capacity at days 16, 45 and 90
Description
The effect of oral administration of nirmatrelvir/ritonavir on physical capacity. Change from baseline as measured by 6-minute walk test.
Time Frame
Baseline and days 16, 45 and 90
Title
Change from baseline in handgrip strength at days 16, 45 and 90
Description
The effect of oral administration of nirmatrelvir/ritonavir on handgrip strength. Change from baseline as measured by JAMAR hand dynamometer.
Time Frame
Baseline and days 16, 45 and 90
Title
Change from baseline in physical activity at days 16, 45 and 90
Description
The effect of oral administration of nirmatrelvir/ritonavir on physical activity. Change from baseline as measured by accelerometer.
Time Frame
Baseline and days 16, 45 and 90
Title
Change from baseline in post-exertional malaise at day 90
Description
The effect of oral administration of nirmatrelvir/ritonavir on post-exertional malaise. Change from baseline in total score as measured by the Post-Exertional Malaise (PEM) short form.
Time Frame
Baseline and day 90
Title
Change from baseline in fatigue at days 16, 45 and 90
Description
The effect of oral administration of nirmatrelvir/ritonavir on fatigue. Change from baseline as measured by the fatigue severity scale (FSS) and mental fatigue scale (MFS).
Time Frame
Baseline and days 16, 45 and 90
Title
Change from baseline in cognitive dysfunction at days 16, 45 and 90
Description
The effect of oral administration of nirmatrelvir/ritonavir on cognitive dysfunction. Change from baseline over time as measured by the Montreal Cognitive Assessment (MoCA) test.
Time Frame
Baseline and days 16, 45 and 90
Title
Change from baseline in dyspnea at days 16, 45 and 90
Description
The effect of oral administration of nirmatrelvir/ritonavir on dyspnea measured as change from baseline in respiratory symptoms using the Chronic obstructive disease assessment (CAT) and Modified Medical Research Council (mMRC) tests.
Time Frame
Baseline and days 16, 45 and 90
Title
Change from baseline in dysfunctional breathing patterns, maximum inspiratory pressure and lung function at days 16, 45 and 90
Description
The effect of oral administration of nirmatrelvir/ritonavir on dysfunctional breathing patterns, maximum inspiratory pressure, and lung function. Change from baseline in Njimegen questionnaire, maximal inspiratory pressure (MIP), forced vital capacity (FVC) and forced expiratory volume in one second (FEV1).
Time Frame
Baseline and days 16, 45 and 90
Title
Change from baseline in plasma biomarkers at days 16, 45 and 90
Description
The effect of oral administration of nirmatrelvir/ritonavir on plasma biomarkers. Change from baseline in the following plasma biomarkers: D-dimer, CRP, ESR, ferritin, NTproBNP and LD.
Time Frame
Baseline and days 16, 45 and 90
Title
Change from baseline in dysautonomia at days 45 and 90
Description
The effect of oral administration of nirmatrelvir/ritonavir on dysautonomia symptoms. Change from baseline as measured using the Composite Autonomic Symptom Score (Compass31) questionnaire.
Time Frame
Baseline and days 45 and 90
Other Pre-specified Outcome Measures:
Title
Change from baseline in breathing patterns at days 16, 45 and 90
Description
The effect of oral administration of nirmatrelvir/ritonavir on breathing pattern. Change from baseline in dynamic spirometry measurements.
Time Frame
Baseline and days 16, 45 and 90
Title
Change from baseline in persistence of SARS-CoV-2 virus at day 16
Description
The effect of oral administration of nirmatrelvir/ritonavir on persistence of SARS-CoV-2 virus as measured by: Protein profiling using Olink Explore Inflammation panel. Nucleosome-profiling (using Volition) and circulating spike (using SIMOA™, Quanterix). PBMC profiling for scTCR-sequencing (using BD Rhapsody) with assessment of Super-Ag-mediated T-cell activation. Immune system signatures associated with disease states using RNA-sequencing of stabilized whole blood (PaxGene).
Time Frame
At baseline and day 16
Title
Change from baseline in immune cell function at day 16
Description
The effect of oral administration of nirmatrelvir/ritonavir on changes in immune cell function as assessed by high-dimensional cytometry.
Time Frame
At baseline and day 16
Title
Change from baseline in relationships between genotypes and immune function at day 16
Description
The effect of oral administration of nirmatrelvir/ritonavir on the relationship between genotypes and immune function at the molecular level. Circulating protein levels adjusted for DNA-variants.
Time Frame
At baseline and day 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject has given written consent to participate in the study. ≥18 years of age at the time of the Screening Visit. Post-acute COVID-19 syndrome (PACS) according to the WHO definition. EQ-5D-5L VAS< 50 All fertile participants must agree to use a highly effective method of contraception for the duration of the study and 28 days after last intake of the IMP. Exclusion Criteria: General exclusion criteria Other non-related conditions with PACS like symptoms. Renal function eGFR eGFRCysC < 60 mL/min/1.73 m2. Not able to comply with the study protocol. Previous Paxlovid treatment. Pregnancy or breastfeeding. Drug-drug interaction with ongoing treatment, including concomitant use of any medications or substances that are strong inducers of CYP3A4 within 28 days prior to first dose of nirmatrelvir/ritonavir and during study treatment. Participants who are planning or considering vaccination (including boosters) through Study Day 45. Active COVID-19 infection as verified by SARS CoV-2 positive antigen test. Self-reported medical conditions, including: Type 1 or Type 2 diabetes mellitus. Chronic kidney disease. Neurodevelopmental disorders (e.g., cerebral palsy, Down's syndrome) or other conditions that confer medical complexity (e.g., genetic or metabolic syndromes and severe congenital anomalies). Active cancer other than localized skin cancer, including those requiring treatment including palliative treatment), as long as the treatment is not among the prohibited medications that must be administered/continued during the trial period. Immunosuppressive disease (e.g., bone marrow or organ transplantation or primary immune deficiencies) OR prolonged use of immune-weakening medications: i. Has received corticosteroids equivalent to prednisone ≥20 mg daily for at least 14 consecutive days within 30 days prior to study entry. ii. Has received treatment with biologics (e.g., infliximab, ustekinumab, etc.), immunomodulators (e.g., methotrexate, 6MP, azathioprine, etc.), or cancer chemotherapy within 90 days prior to study entry. iii. HIV infection with CD4+ cell count <200/mm3. History of hospitalization for the medical treatment of acute COVID-19 Current need for hospitalization or anticipated need for hospitalization within 48 hours after randomization in the clinical opinion of the site investigator. Prior/Concomitant Therapy: Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance, and for which elevated plasma concentrations may be associated with serious and/or life-threatening events during treatment and for 4 days after the last dose of nirmatrelvir/ritonavir. List of potential interactions provided by Pfizer provided in Appendix A. Has received or is expected to receive monoclonal antibody treatment, antiviral treatment (e.g., molnupiravir), or convalescent COVID-19 plasma. Prior/Concurrent Clinical Study Experience: Is unwilling to abstain from participating in another interventional clinical study with an investigational compound or device, including those for post-COVID-19 therapeutics, through the long-term follow-up visit. Previous administration with any investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Known prior participation in this trial or other trial involving nirmatrelvir. Diagnostic Assessments: Known history of any of the following abnormalities in clinical laboratory tests (within past 6 months of the screening visit): AST or ALT level ≥2.5 X ULN Total bilirubin ≥2 X ULN (≥3 X ULN for Gilbert's syndrome)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Petter Brodin, MD, PhD
Phone
+46 8 52481396
Email
petter.brodin@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Judith Bruchfeld, MD, PhD
Email
judith.bruchfeld@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Runold, MD, PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
SE171 77
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petter Brodin, MD PhD
Phone
+46 8 52481396
Email
petter.brodin@ki.se

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34313468
Citation
Caruso D, Guido G, Zerunian M, Polidori T, Lucertini E, Pucciarelli F, Polici M, Rucci C, Bracci B, Nicolai M, Cremona A, De Dominicis C, Laghi A. Post-Acute Sequelae of COVID-19 Pneumonia: Six-month Chest CT Follow-up. Radiology. 2021 Nov;301(2):E396-E405. doi: 10.1148/radiol.2021210834. Epub 2021 Jul 27.
Results Reference
background
PubMed Identifier
33497317
Citation
Han X, Fan Y, Alwalid O, Li N, Jia X, Yuan M, Li Y, Cao Y, Gu J, Wu H, Shi H. Six-month Follow-up Chest CT Findings after Severe COVID-19 Pneumonia. Radiology. 2021 Apr;299(1):E177-E186. doi: 10.1148/radiol.2021203153. Epub 2021 Jan 26.
Results Reference
background
PubMed Identifier
34973396
Citation
Ceban F, Ling S, Lui LMW, Lee Y, Gill H, Teopiz KM, Rodrigues NB, Subramaniapillai M, Di Vincenzo JD, Cao B, Lin K, Mansur RB, Ho RC, Rosenblat JD, Miskowiak KW, Vinberg M, Maletic V, McIntyre RS. Fatigue and cognitive impairment in Post-COVID-19 Syndrome: A systematic review and meta-analysis. Brain Behav Immun. 2022 Mar;101:93-135. doi: 10.1016/j.bbi.2021.12.020. Epub 2021 Dec 29.
Results Reference
background
PubMed Identifier
36131932
Citation
Goh D, Lim JCT, Fernaindez SB, Joseph CR, Edwards SG, Neo ZW, Lee JN, Caballero SG, Lau MC, Yeong JPS. Case report: Persistence of residual antigen and RNA of the SARS-CoV-2 virus in tissues of two patients with long COVID. Front Immunol. 2022 Sep 5;13:939989. doi: 10.3389/fimmu.2022.939989. eCollection 2022. Erratum In: Front Immunol. 2022 Oct 06;13:1036894.
Results Reference
background
PubMed Identifier
36213654
Citation
Visvabharathy L, Orban ZS, Koralnik IJ. Case report: Treatment of long COVID with a SARS-CoV-2 antiviral and IL-6 blockade in a patient with rheumatoid arthritis and SARS-CoV-2 antigen persistence. Front Med (Lausanne). 2022 Sep 23;9:1003103. doi: 10.3389/fmed.2022.1003103. eCollection 2022.
Results Reference
background
PubMed Identifier
35172054
Citation
Hammond J, Leister-Tebbe H, Gardner A, Abreu P, Bao W, Wisemandle W, Baniecki M, Hendrick VM, Damle B, Simon-Campos A, Pypstra R, Rusnak JM; EPIC-HR Investigators. Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19. N Engl J Med. 2022 Apr 14;386(15):1397-1408. doi: 10.1056/NEJMoa2118542. Epub 2022 Feb 16.
Results Reference
background
PubMed Identifier
35712797
Citation
Toussi SS, Neutel JM, Navarro J, Preston RA, Shi H, Kavetska O, LaBadie RR, Binks M, Chan PLS, Demers N, Corrigan B, Damle B. Pharmacokinetics of Oral Nirmatrelvir/Ritonavir, a Protease Inhibitor for Treatment of COVID-19, in Subjects With Renal Impairment. Clin Pharmacol Ther. 2022 Oct;112(4):892-900. doi: 10.1002/cpt.2688. Epub 2022 Jul 5.
Results Reference
background
PubMed Identifier
28245088
Citation
Sundaram A, Vaughan B, Kost K, Bankole A, Finer L, Singh S, Trussell J. Contraceptive Failure in the United States: Estimates from the 2006-2010 National Survey of Family Growth. Perspect Sex Reprod Health. 2017 Mar;49(1):7-16. doi: 10.1363/psrh.12017. Epub 2017 Feb 28.
Results Reference
background
PubMed Identifier
36052466
Citation
Swank Z, Senussi Y, Manickas-Hill Z, Yu XG, Li JZ, Alter G, Walt DR. Persistent Circulating Severe Acute Respiratory Syndrome Coronavirus 2 Spike Is Associated With Post-acute Coronavirus Disease 2019 Sequelae. Clin Infect Dis. 2023 Feb 8;76(3):e487-e490. doi: 10.1093/cid/ciac722.
Results Reference
background
Links:
URL
http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2020_09_HMA_CTFG_Contraception_guidance_Version_1.1_updated.pdf
Description
Recommendations related to contraception and pregnancy testing in clinical trials
URL
http://www.ema.europa.eu/en/documents/assessment-report/paxlovid-epar-public-assessment-report_en.pdf
Description
European Medicines Agency Assessment Report for Paxlovid
URL
http://www.pfizer.com
Description
Information related to Paxlovid
URL
http://erj.ersjournals.com/content/58/suppl_65/PA487
Description
Late breaking abstract 2021 ERS International Congress - Early follow-up of hospitalised and non-hospitalised patients with Covid-19 in a Swedish setting

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imPROving Quality of LIFe In the Long COVID Patient

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