Sumathi Sivapalasingam
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View article: Reliability and Validity of an Instrument of COVID-19 Patient-Reported Symptoms in Outpatients
Reliability and Validity of an Instrument of COVID-19 Patient-Reported Symptoms in Outpatients Open
Importance Patient-reported outcome instruments are key in assessing COVID-19–related symptoms and associated burden. However, a valid and reliable instrument to assess symptom severity and progression among outpatients with COVID-19 is no…
View article: Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19
Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19 Open
Background The open-label RECOVERY study reported improved survival in hospitalized, SARS-CoV-2 seronegative patients treated with casirivimab and imdevimab (CAS + IMD). Methods In this phase 1/2/3, double-blind, placebo-controlled trial c…
View article: A drug‐disease model for predicting survival in an Ebola outbreak
A drug‐disease model for predicting survival in an Ebola outbreak Open
REGN‐EB3 (Inmazeb) is a cocktail of three human monoclonal antibodies approved for treatment of Ebola infection. This paper describes development of a mathematical model linking REGN‐EB3’s inhibition of Ebola virus to survival in a non‐hum…
View article: Development and content validation of the Symptoms Evolution of COVID-19: a patient-reported electronic daily diary in clinical and real-world studies
Development and content validation of the Symptoms Evolution of COVID-19: a patient-reported electronic daily diary in clinical and real-world studies Open
View article: Patient experience of symptoms and impacts of COVID-19: a qualitative investigation with symptomatic outpatients
Patient experience of symptoms and impacts of COVID-19: a qualitative investigation with symptomatic outpatients Open
Objectives There is little in-depth qualitative evidence of how symptoms manifest themselves in outpatients with COVID-19 and how these in turn impact outpatients’ daily lives. The objective of the study was therefore to explore the experi…
View article: Efficacy and Safety of Sarilumab in Hospitalized Patients With Coronavirus Disease 2019: A Randomized Clinical Trial
Efficacy and Safety of Sarilumab in Hospitalized Patients With Coronavirus Disease 2019: A Randomized Clinical Trial Open
Background Open-label platform trials and a prospective meta-analysis suggest efficacy of anti–interleukin (IL)-6R therapies in hospitalized patients with coronavirus disease 2019 (COVID-19) receiving corticosteroids. This study evaluated …
View article: A reliable and valid measure of COVID-19 patient-reported symptoms in outpatients: the Symptoms Evolution of COVID-19 (SE-C19) instrument
A reliable and valid measure of COVID-19 patient-reported symptoms in outpatients: the Symptoms Evolution of COVID-19 (SE-C19) instrument Open
Background There is no valid and reliable patient self-reported measure assessing symptomology among outpatients with COVID-19. The Symptoms Evolution of COVID-19 (SE-C19) is a self-administered new instrument that includes 23 symptoms, ea…
View article: Casirivimab and imdevimab for the treatment of hospitalized patients with COVID-19
Casirivimab and imdevimab for the treatment of hospitalized patients with COVID-19 Open
Background Hospitalized patients with COVID-19 experience high mortality rates, ranging from 10% to 30%. Combined casirivimab and imdevimab (CAS+IMD) is authorized for use in outpatients with COVID-19 and in post-exposure prophylaxis. The …
View article: LB4. Casirivimab and Imdevimab for Treatment of Hospitalized Patients With COVID-19 Receiving Low Flow or No Supplemental Oxygen
LB4. Casirivimab and Imdevimab for Treatment of Hospitalized Patients With COVID-19 Receiving Low Flow or No Supplemental Oxygen Open
Background Casirivimab and imdevimab (CAS/IMDEV) is authorized for emergency use in the US for outpatients with COVID-19. We present results from patient cohorts receiving low flow or no supplemental oxygen at baseline from a phase 1/2/3, …
View article: Baseline Severe Acute Respiratory Syndrome Viral Load Is Associated With Coronavirus Disease 2019 Severity and Clinical Outcomes: Post Hoc Analyses of a Phase 2/3 Trial
Baseline Severe Acute Respiratory Syndrome Viral Load Is Associated With Coronavirus Disease 2019 Severity and Clinical Outcomes: Post Hoc Analyses of a Phase 2/3 Trial Open
Background Elucidating the relationship between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load and clinical outcomes is critical for understanding coronavirus disease 2019 (COVID-19). Methods The SARS-CoV-2 levels …
View article: Development and Content Validation of the Symptoms Evolution of COVID-19: A Patient-Reported Electronic Daily Diary in Clinical and Real-World Studies
Development and Content Validation of the Symptoms Evolution of COVID-19: A Patient-Reported Electronic Daily Diary in Clinical and Real-World Studies Open
Importance At the onset of the COVID-19 pandemic, there was limited understanding of symptom experience and disease progression. Objective We developed and validated a fit-for-purpose, disease-specific instrument to assess symptoms in pati…
View article: REGEN-COV Antibody Combination in Outpatients With COVID-19 – Phase 1/2 Results
REGEN-COV Antibody Combination in Outpatients With COVID-19 – Phase 1/2 Results Open
Background Continued SARS-CoV-2 infections and COVID-19-related hospitalizations highlight the need for effective anti-viral treatments in the outpatient setting. In a descriptive interim analysis of the phase 1/2 portion of a double-blind…
View article: The monoclonal antibody combination REGEN-COV protects against SARS-CoV-2 mutational escape in preclinical and human studies
The monoclonal antibody combination REGEN-COV protects against SARS-CoV-2 mutational escape in preclinical and human studies Open
Monoclonal antibodies against SARS-CoV-2 are a clinically validated therapeutic option against COVID-19. Because rapidly emerging virus mutants are becoming the next major concern in the fight against the global pandemic, it is imperative …
View article: The patient experience of COVID-19: A qualitative investigation with symptomatic outpatients
The patient experience of COVID-19: A qualitative investigation with symptomatic outpatients Open
Summary Background Coronavirus disease 2019 (COVID-19) is an acute respiratory illness characterised by a range of symptoms. Severe cases of COVID-19 could lead to hospitalisation and intensive care unit admission. However, little is known…
View article: REGEN-COV Antibody Cocktail Clinical Outcomes Study in Covid-19 Outpatients
REGEN-COV Antibody Cocktail Clinical Outcomes Study in Covid-19 Outpatients Open
Background REGEN-COV antibody cocktail (casirivimab with imdevimab) rapidly reduced viral load and decreased medically-attended visits in the phase 1/2 portion of this trial; REGEN-COV, retains activity in vitro against emerging SARS-CoV-2…
View article: A Randomized Placebo-Controlled Trial of Sarilumab in Hospitalized Patients with Covid-19
A Randomized Placebo-Controlled Trial of Sarilumab in Hospitalized Patients with Covid-19 Open
BACKGROUND Sarilumab (anti-interleukin-6 receptor-α monoclonal antibody) may attenuate the inflammatory response in Covid-19. METHODS We performed an adaptive, phase 2/3, randomized, double-blind, placebo-controlled trial of intravenous sa…
View article: A Retrospective Study of COVID-19-Related Urgent Medical Visits and Hospitalizations After Outpatient COVID-19 Diagnosis in the US
A Retrospective Study of COVID-19-Related Urgent Medical Visits and Hospitalizations After Outpatient COVID-19 Diagnosis in the US Open
View article: REGEN-COV protects against viral escape in preclinical and human studies
REGEN-COV protects against viral escape in preclinical and human studies Open
Summary Monoclonal antibodies against SARS-CoV-2 are a clinically validated therapeutic option against COVID-19. As rapidly emerging virus mutants are becoming the next major concern in the fight against the global pandemic, it is imperati…
View article: Human Monoclonal Antibody Cocktail for the Treatment or Prophylaxis of Middle East Respiratory Syndrome Coronavirus
Human Monoclonal Antibody Cocktail for the Treatment or Prophylaxis of Middle East Respiratory Syndrome Coronavirus Open
Background REGN3048 and REGN3051 are human monoclonal antibodies (mAb) targeting the spike glycoprotein on the Middle East respiratory syndrome coronavirus (MERS-CoV), which binds to the receptor dipeptidyl peptidase-4 (DPP4) and is necess…
View article: Baseline SARS-CoV-2 Viral Load Is Associated with Disease Severity and Clinical Outcomes in Hospitalised Patients with COVID-19: Post-Hoc Analyses of a Phase 2/3 Multicentre Trial
Baseline SARS-CoV-2 Viral Load Is Associated with Disease Severity and Clinical Outcomes in Hospitalised Patients with COVID-19: Post-Hoc Analyses of a Phase 2/3 Multicentre Trial Open
View article: REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19
REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19 Open
In this interim analysis, the REGN-COV2 antibody cocktail reduced viral load, with a greater effect in patients whose immune response had not yet been initiated or who had a high viral load at baseline. Safety outcomes were similar in the …
View article: Suptavumab for the Prevention of Medically Attended Respiratory Syncytial Virus Infection in Preterm Infants
Suptavumab for the Prevention of Medically Attended Respiratory Syncytial Virus Infection in Preterm Infants Open
Background Respiratory syncytial virus (RSV) is a major cause of childhood medically attended respiratory infection (MARI). Methods We conducted a randomized, double-blind, placebo-controlled phase 3 trial in 1154 preterm infants of 1 or 2…
View article: Complement levels in patients with bloodstream infection due to Staphylococcus aureus or Gram-negative bacteria
Complement levels in patients with bloodstream infection due to Staphylococcus aureus or Gram-negative bacteria Open
View article: Studies in humanized mice and convalescent humans yield a SARS-CoV-2 antibody cocktail
Studies in humanized mice and convalescent humans yield a SARS-CoV-2 antibody cocktail Open
An antibody cocktail against SARS-CoV-2 There is an urgent focus on antibodies that target the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral spike and prevent the virus from entering host cells. Hansen et al. generated…
View article: Integrating Household Water Treatment, Hand Washing, and Insecticide-Treated Bed Nets Into Pediatric HIV Care in Mombasa, Kenya: Impact on Diarrhea and Malaria Risk
Integrating Household Water Treatment, Hand Washing, and Insecticide-Treated Bed Nets Into Pediatric HIV Care in Mombasa, Kenya: Impact on Diarrhea and Malaria Risk Open
Introduction: In developing countries, HIV-infected children are at higher risk of morbidity and mortality from opportunistic infections than HIV-uninfected children. To address this problem, the Healthy Living Initiative (HLI) in Mombasa,…
View article: Phase 1 Study Evaluating Safety, Tolerability, Pharmacokinetics and Immunogenicity of REGN2222 in Healthy Adults: A New Human Monoclonal RSV-F Antibody for RSV Prevention
Phase 1 Study Evaluating Safety, Tolerability, Pharmacokinetics and Immunogenicity of REGN2222 in Healthy Adults: A New Human Monoclonal RSV-F Antibody for RSV Prevention Open