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Principal Investigator: H. Clifford Lane
Organization: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
Fiscal Year: 2022
Award: $138,903
Funding agency: National Institute of Allergy and Infectious Diseases
Research in this project is currently focused on six areas. These are: characterization of the survivors of the anthrax attacks of 2001; characterization of emerging respiratory infections including SARS, COVID-19, and influenza; evaluation of experimental vaccines and treatments for Ebola virus; characterizing the long-term sequelae of Ebola virus infection; evaluating experimental therapeutics for COVID-19; characterizing the long-term sequelae of SARS-CoV-2 infection.
The anthrax study has enrolled a cohort of volunteers who are currently undergoing an extensive diagnostic evaluation.
The Prevail 4 trial enrolled 38 men who had survived Ebola virus infection and had persistent evidence of Ebola virus RNA in their semen and randomized them to receive remdesivir at a dose of 100 mg/d for five days. While no differences in RNA persistence were noted a the end of the infusions; patients randomized to remdesivir had more negative samples in follow-up (96% vs. 81%; p=0.041)
The COVID-19 therapeutic trial ACTIV-3, followed its placebo-controlled study of bamlanivimab (a monoclonal antibody directed toward the spike protein of SARS CoV-2) with studies of the Brii monoclonal antibody cocktail (amubarvimab-romlusevimab), the Vir antibody sotrovimab, the Astra-Zeneca combination of antibodies (tixagevimab-cilgavimab) and the Molecular Partners/Novartis darpins (ensovibep). While none of these showed benefit for the primary endpoint of time to recovery, the Astra-Zeneca arm showed an overall improvement in survival in a secondary endpoint. Separating patients into groups based upon baseline levels of antibody to SARS-CoV-2 and plasma levels of SARS-CoV-2 nucleocapsid antigen demonstrated a potential benefit for bamlanivimab in the group that was antibody negative and strongly antigen positive.
A randomized, placebo-controlled trial of COVID-19 immune immunoglobulin in hospitalized patients failed to show benefit.
A longitudinal study of COVID-19 survivors and controls demonstrated that symptoms consistent with post-acute sequelae of SARS-CoV-2 infection (PASC) were reported by 55% of the COVID-19 cohort and 13% of control participants. Increased risk for PASC was noted in women and those with a history of anxiety disorder. Abnormal findings on physical examination and diagnostic testing were uncommon. Exploratory studies found no evidence of persistent viral infection, autoimmunity, or abnormal immune activation in participants with PASC.
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events><Recovery><Reporting><Research><Respiratory Infections><Respiratory Tract Infections><Reticuloendothelial System, Serum, Plasma><Ribonucleic Acid><Risk><Role><SARS><SARS corona virus 2><SARS coronavirus disease><SARS-CO-V2><SARS-COVID-2><SARS-CoV disease><SARS-CoV-2><SARS-CoV-2 S protein><SARS-CoV-2 antibody><SARS-CoV-2 infection><SARS-CoV-2 spike glycoprotein><SARS-CoV-2 spike protein><SARS-CoV-2 survivors><SARS-CoV-2 therapeutics><SARS-CoV-2 therapy><SARS-CoV-2 treatment><SARS-CoV2><SARS-CoV2 S protein><SARS-CoV2 antibody><SARS-CoV2 infection><SARS-CoV2 spike glycoprotein><SARS-CoV2 spike protein><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-coronavirus-2 therapeutics><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Safety><Sampling><Semen><Seminal fluid><Severe Acute Respiratory Coronavirus 2><Severe Acute Respiratory Distress Syndrome CoV 2><Severe Acute Respiratory Distress Syndrome Corona Virus 2><Severe Acute 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placebo control trial><randomized placebo controlled trial><randomly assigned><remdesivir><secondary end point><secondary endpoint><severe acute respiratory syndrome coronavirus 2 antibody><severe acute respiratory syndrome coronavirus 2 therapy><severe acute respiratory syndrome coronavirus 2 treatment><social role><survive COVID-19><survive SARS-CoV-2><therapeutics against COVID-19><therapeutics against COVID19><therapeutics against SARS-CoV-2><therapeutics against SARS-coronavirus-2><therapeutics against Severe acute respiratory syndrome coronavirus 2><therapeutics against coronavirus disease 2019><therapeutics for novel coronavirus><treat COVID-19><treat COVID19><treat SARS-CoV-2><treat coronavirus disease 2019><treat severe acute respiratory syndrome coronavirus 2><viral RNA><viral infection><virus RNA><virus infection><virus-induced disease><volunteer>