ABSTRACT
Background: Reliable biomarkers of COVID-19 severity and outcomes are critically needed for clinical and research applications. We evaluated associations between anti-Spike IgG and SARS-COV-2 nucleocapsid antigen (N Ag) in plasma with clinical outcomes in outpatients with COVID-19. Method(s): We used data from 229 non-hospitalized, US-based adults with COVID-19 who enrolled between January and July 2021 into the placebo arm of the ACTIV-2/A5401 platform trial within 10 days of symptom onset. Pretreatment (day 0) plasma was analyzed by the quantitative Simoa SARS-CoV-2 IgG antibody (anti-Spike) assay (lower limit of quantification [LLoQ] 0.77ug/ mL), and the quantitative Simoa SARS-CoV-2 N Protein Advantage (Quanterix) measuring N Ag (LLoQ 3pg/mL). In addition to analyses for < LLoQ vs >=LLoQ anti-Spike and N Ag, we categorized participants into five N Ag groups (< 3 pg/ml;3-< 100 pg/ml;100-< 1,000 pg/ml;1,000-< 2,500 pg/ml;>=2,500 pg/ ml). Associations between SARS-CoV-2 anti-Spike and N Ag levels and clinical outcomes (all-cause hospitalization/death through day 28 and time to symptom improvement or resolution for two consecutive days from day 0 status) were estimated using log-binomial and Cox regression models, respectively. Result(s): At day 0, 40% had anti-Spike levels >=LLoQ and 64% of participants had plasma N Ag levels >=LLoQ. Participants with anti-Spike levels < LLoQ compared to those who had quantifiable anti-Spike at day 0, had an increased risk of hospitalization/death (16% vs 2%, RR [95% confidence interval (CI)]: 7.3 [1.8, 30.1]), and a significantly longer time to symptom improvement (median [Q1, Q3] 14 days [8, >27] vs 9 days [4, 16], hazard ratio [HR]: 0.6 [95%: CI: 0.4, 0.8], p< 0.001). Participants with higher N Ag levels at day 0 had an increased risk of hospitalization or death, ranging from 1% for < 3 pg/ml to 70% for >=2500 pg/ml (Figure). Compared to individuals who had N Ag levels < LLoQ at day 0, those in the highest category of N Ag levels (>=2500 pg/mL) experienced a significantly longer time to symptom improvement (median [Q1, Q3]: 25 days [13, >27] vs 10 days [5, 20];HR: 0.4 [95% CI: 0.2, 0.7];p=0.04). Conclusion(s): At study entry, the absence of Spike antibodies and higher levels of plasma SARS-CoV-2 N Ag predicted hospitalizations and death in untreated outpatients with COVID-19. These parameters may serve as informative biomarkers for risk stratification in the evaluation of outpatients with COVID-19. (Figure Presented).
ABSTRACT
Background: SARS-CoV-2 variants resistant to monoclonal antibodies, and drug-drug interactions and potential mutagenicity of direct acting antivirals, heightens the need for additional therapeutics to prevent progression to severe COVID-19. Exogenous interferon beta is a promising therapeutic option against SARS-CoV-2 given its broad-spectrum antiviral activity and data suggesting impaired endogenous IFN production in individuals with severe disease. Method(s): The safety and efficacy of orally inhaled nebulized interferon-beta1a (SNG001) was evaluated in a Phase II randomized controlled trial on the ACTIV-2/ A5401 platform (NCT04518410). Adult outpatients with confirmed SARS-CoV-2 infection within 10 days of symptom onset were randomized to SNG001 once daily for 14 days or blinded pooled placebo. Primary outcomes included treatment-emergent Grade >=3 adverse event (TEAE) through day 28;time to symptom improvement of 13 targeted COVID-19 symptoms collected by daily study diary through day 28;and SARS-CoV-2 RNA < lower limit of quantification (LLoQ) from nasopharyngeal (NP) swabs at days 3, 7, and 14. All-cause hospitalization or death through day 28 was a key secondary outcome. Result(s): Of 221 participants enrolled at 25 US sites between February and August 2021, 220 (110 SNG001, 110 placebo) initiated study intervention, with a median age of 40 years, 55% female, and 20% SARS-CoV-2 vaccinated. There was no significant difference between SNG001 and placebo in Grade >=3 TEAEs (4% vs 8%, Fisher's exact test p=0.25). Median time to symptom improvement was 13 days for SNG001 and 9 days for placebo (Gehan-Wilcoxon test p=0.17). There was no difference in the proportion of participants with SARS-CoV-2 RNA < LLoQ at day 3, 7 or 14 (SNG001 vs placebo, Day 3: 28% vs. 39%;Day 7: 65% vs. 66%;Day 10: 91% vs. 91%;joint Wald test p=0.41). There were fewer hospitalizations with SNG001 (n=1;1%) compared with placebo (n=7;6%), but this difference was not statistically significant (Fisher's exact test p=0.07;Figure). All hospitalizations were due to COVID-19 and occurred among unvaccinated participants without protocol-defined high-risk factors. Conclusion(s): Inhaled nebulized SNG001 was safe and well tolerated but did not reduce SARS-CoV-2 RNA levels in the nasopharynx nor decrease time to improvement of COVID-19 symptoms in outpatients with mild-to-moderate COVID-19. The non-statistically significant decrease in hospitalizations among SNG001 participants warrants further investigation in a phase 3 clinical trial. Cumulative incidence of hospitalization or death comparing SNG001 vs. placebo.
ABSTRACT
Background: Amubarvimab and romlusevimab are anti-SARS-CoV-2 monoclonal antibodies (mAbs) that significantly reduced the risk of hospitalizations or death in the ACTIV-2/A5401 trial. SARS-CoV-2 variants (e.g., Delta, Epsilon, Lambda) harbor mutations against romlusevimab. We evaluated viral kinetics and resistance emergence in individuals treated with mono versus dual-active mAbs. Method(s): The study population included 789 non-hospitalized participants at high risk of progression to severe COVID-19 enrolled in the ACTIV-2/ A5401 platform trial (NCT04518410) and received either placebo (n=400) or amubarvimab plus romlusevimab (n=389). Anterior nasal (AN) swabs were collected for SARS-CoV-2 RNA testing on days 0-14, and 28. Spike (S) gene nextgeneration sequencing were performed on samples collected at study entry and the last sample with viral load >=2 log10 SARS-CoV-2 RNA copies per ml. We compared viral load kinetics and resistance emergence with single versus dual-active mAbs by categorizing participants as harboring variants sensitive to amubarvimab alone (Delta, Epsilon, Lambda, Mu) versus those sensitive to both mAbs (Alpha, Beta, Gamma, Others). Result(s): Study participants receiving single and dual-active mAbs had similar demographics, baseline AN viral load, baseline symptom score and duration since symptom onset. The most common SARS-CoV-2 variant in the study population was Delta (26%) followed by Gamma (19%), Alpha (12%), and Epsilon (10%). In those with successful sequencing, 37% (N=111) were infected with a variant sensitive to amubarvimab alone and 63% (N=188) were infected with a variant sensitive to both mAbs. Compared to treatment with a singleactive mAb, treatment with dual-active mAbs led to faster viral load decline at study day 3 (p=0.0001) and day 7 (p=0.003). Treatment-emergent resistance mutations were significantly more likely to be detected after amubarvimab plus romlusevimab treatment than placebo (2.6% vs 0%, P=0.0008). mAb resistance was also more frequently detected in the setting of single-active mAb treatment compared to dual-active mAb treatment (7.2% vs 1.1%, p=0.007). Participants with emerging mAb resistance had significantly higher pretreatment SARS-CoV-2 nasal viral RNA levels. Conclusion(s): Compared to single-active mAb therapy, dual-active mAb therapy led to significantly faster viral load decline and lower risk of emerging mAb resistance. Combination mAb therapy should be prioritized for the next generation of mAb therapeutics.
ABSTRACT
Background. Symptoms during acute COVID-19 can limit daily activities and delay return to work and school. Little is known about the association between SARS-CoV-2 burden in either the upper airway or plasma and the duration of COVID-19 symptoms. Methods. ACTIV-2/A5401 is a platform trial for COVID-19 treatments in nonhospitalized symptomatic adults enrolled within 10 days of symptom onset. We included participants randomized to placebo from August 2020 to July 2021. Participants self-reported severity of 13 symptoms daily from day 0 (baseline) to 28 as Absent 0, Mild 1, Moderate 2, Severe 3;total symptom score was calculated as the sum of all scores. Anterior nasal (AN) and plasma SARS-CoV-2 RNA levels at day 0 were measured with a quantitative qPCR assay. The relationship between day 0 RNA and time to symptom improvement or resolution (first of 2 consecutive days of all symptoms improved or resolved from day 0, respectively) was evaluated using proportional hazards regression adjusted for time from symptom onset. Time to resolution of distinct symptoms was also assessed. Results. Among 570 participants randomized to placebo, median age was 48 years, 51% were female, and median time since symptom onset at baseline was 6 days;7% had prior COVID-19 vaccination. At day 0, AN RNA was detectable in 80% with a median of 4.1 log10 copies/ml (n=533, quartiles: 1.7, 6.0) and plasma RNA was detectable in 19% (91/476). Detectable plasma RNA at day 0, but not AN RNA, was associated with more severe symptoms at day 0 (2.4-point higher mean total symptom score, P=0.001). Both high AN (>=6 vs < 2 log10 copies/ml, adjusted hazard ratio [aHR] 0.63, P=0.001) and detectable plasma RNA (aHR 0.74, P=0.03) at day 0 predicted delayed symptom improvement. High AN RNA at day 0 also predicted a delay in symptom resolution (aHR 0.59, P=0.001). Both high AN RNA and detectable plasma RNA levels predicted delays in the resolution of cough and shortness of breath. Detectable plasma RNA also predicted delayed body pain resolution.
ABSTRACT
Background. Data are currently limited on the performance of SARS-CoV-2 RNA levels as predictors or surrogate markers for clinical outcomes in outpatients with mild-to-moderate COVID-19. Methods. This exploratory analysis used data from 2205 non-hospitalized adults who enrolled between August 2020 and July 2021 and participated in placebocontrolled evaluations of two monoclonal antibody (mAb) agents (bamlanivimab [n=317] or amubarvimab/romlusevimab [n=837]), and an open-label cohort of bamlanivimab recipients [n=1051] as part of the ACTIV-2/A5401 platform trial. SARS-CoV-2 RNA levels were measured in anterior nasal (AN) swabs and plasma at day 0 (pre-treatment) and AN at day 3. We fit regression models to estimate the association between RNA level or detection and subsequent hospitalization/death within 28 days of enrollment. Results. One-hundred four participants (53/571 [9%] on placebo and 51/ 1634 [3%] on mAb) died or were hospitalized through day 28. Median AN RNA levels were lower at day 3 compared to day 0 in both placebo (2.5 vs 4.0 log10 copies/mL [cp/mL]) and mAb (2.3 vs 4.9) groups. For placebo recipients, higher Day 0 AN RNA was associated with an increasing risk of hospitalization/ death, ranging from 3% to 16% for < 2 and >= 6 log10 cp/mL, respectively. Although only 1% had quantifiable plasma SARS-CoV-2 RNA, there was a similar trend for day 0 plasma RNA: 5% hospitalizations/death for undetectable RNA, 16% for detectable but not quantifiable RNA, and 80% for >= 2 log10 cp/mL. Among 485 placebo recipients with days 0 and 3 ANRNA results, the risk of subsequent hospitalization/death was highest among those with >= 5.0 log10 cp/mL at both days [8/78;10%] and lowest for those with unquantifiable levels at both days [0/124;0%]. Higher AN RNA at day 3 (adjusted for day 0 RNA) was associated with subsequent hospitalization/death among placebo recipients (relative risk (RR): 1.4 per log10 cp/mL;95%CI: 1.0, 2.1), but not mAb recipients (RR: 1.0;95%CI: 0.7, 1.6). Conclusion. These findings suggest that AN and plasma SARS-CoV-2 RNA levels are predictive of hospitalization/death in the natural history setting. However, different associations for mAb and placebo recipients raises concerns for using AN RNA as a surrogate for clinical outcomes in mAb trials. (Table Presented).
ABSTRACT
Background: The discovery and development of SARS-CoV-2 therapies remains a priority. SAB-185 is a Transchromosomic, bovine-derived, fully human polyclonal immunoglobulin product for SARS-CoV-2 being studied in ACTIV-2, randomized controlled platform trial evaluating the safety and efficacy of investigational agents for non-hospitalized adults with mild-moderate COVID-19 Methods: This Phase II trial was a superiority comparison of SAB-185 vs. placebo. Participants with confirmed SAR-CoV-2 infection received intravenous infusion of SAB-185 (3,840 Units/kg) or placebo. Primary outcome measures were proportion of participants with SARS-CoV-2 RNA < lower limit of quantification (LLoQ) in nasopharyngeal (NP) swab, time to improvement in targeted symptoms for 2 consecutive days after Day 0, and safety through Day 28. Secondary outcomes included quantitative NP RNA levels and all-cause hospitalizations and deaths. Antiviral or clinical efficacy and safety criteria for graduation to Phase III were pre-specified. Results: From April to August 2021, randomized participants from 42 sites in the US received SAB-185 (N=107) or placebo (N=106). Median age was 38 years (quartiles: 30,48), 54% female, >98% cis-gender, 7% Black/African-American, 50% Hispanic, and 11% were classified as high-risk for COVID-19 progression, with median 4 days (3,6) from symptom onset. Day 0 NP SARS-CoV-2 RNA levels were similar between SAB-185 and placebo: 4.80 vs 4.80 log10 copies/ml. No differences were observed in the proportion with NP SARS-CoV-2 RNA< lower limit of quantification (LLoQ) in nasopharyngeal (NP) swab, time to improvement in targeted symptoms for 2 consecutive days after Day 0, and safety through Day 28. Secondary outcomes included quantitative NP RNA levels and all-cause hospitalizations and deaths. Antiviral or clinical efficacy and safety criteria for graduation to phase 3 were pre-specified. Conclusion: SAB-185 was safe in this Phase II study. While no significant differences to placebo were seen in symptom duration and proportion of participants with NP SARS-CoV-2 RNA< lower limit of quantification (LLoQ) in nasopharyngeal (NP) swab, time to improvement in targeted symptoms for 2 consecutive days after Day 0, and safety through Day 28. Secondary outcomes included quantitative NP RNA levels and all-cause hospitalizations and deaths. Antiviral or clinical efficacy and safety criteria for graduation to phase 3 were pre-specified.
ABSTRACT
Background: Camostat, a serine protease inhibitor, prevents activation of the SARS-CoV-2 spike protein and blocks SARS-CoV-2 infection in vitro. We studied the safety and antiviral and clinical efficacy of orally administered camostat in non-hospitalized adults with mild-moderate COVID-19. Methods: ACTIV-2/A5401 is a platform trial to evaluate therapies for non-hospitalized adults with mild-moderate COVID-19. In a Phase II portion of the study, participants were enrolled within 10 days of COVID-19 related symptom onset and randomized to camostat 200 mg orally every 6 hours for 7 days or the pooled placebo group. Objectives were to evaluate the safety and efficacy of camostat to reduce the duration of COVID-19 symptoms and increase the proportion of participants with SARS-CoV-2 RNA below the lower limit of quantification (LLoQ) from nasopharyngeal (NP) swabs on days 3, 7, and 14. Participants completed a study diary from day 0 to day 28 scoring COVID-19 symptoms as absent, mild, moderate, or severe. Results: Of the 224 participants enrolled from 54 US sites, 215 participants (108 camostat, 107 placebo) initiated study intervention and formed the modified intent-to-treat population. Fifty-four percent were female, >99% cis-gender, 85% White, 9% Black, and 51% Latinx. Median age was 37 years;47% reported ≤5 days of symptoms at study entry and 26% met the protocol definition of higher risk of progression to severe COVID-19. Most frequent symptoms on day 0 were cough (86%), fatigue (85%), nasal obstruction/congestion (71%) and body/muscle aches (71%). There was no significant difference between camostat and placebo arms in grade 3 or higher adverse events (7.4% vs. 6.5%, respectively). Median (Q1, Q3) time to symptom improvement was 9 days for both camostat (5, 20) and placebo (6, 19). There were no significant differences in the proportion of participants with NP SARS-CoV-2 RNA<="" div=""> Conclusion: Camostat was well-tolerated. Despite compelling in vitro data, camostat did not show evidence of antiviral or clinical efficacy in ACTIV-2/A5401. This highlights the critical importance of randomized controlled trials in the evaluation of therapies for COVID-19.
ABSTRACT
Background. SARS-CoV-2 continues to spread and the development of safe and effective therapeutics for the prevention of severe disease remains a priority. BRII-196 and BRII-198 are non-competing anti-SARS-CoV-2 mAbs with YTE triple amino acid substitution in Fc to extend half-life and reduce receptor binding, that are being studied for treatment of COVID-19 in the ACTIV-2 Trial, sponsored by NIAID and led by ACTG. Methods. ACTIV-2 evaluates safety/efficacy of investigational agents for treatment of non-hospitalized adults with mild-moderate COVID-19 under a randomized, blinded, controlled adaptive platform. BRII-196/BRII-198 (1000 mg each) as a single dose given as sequential infusions, or placebo to those at high risk of clinical progression (i.e., age ≥ 60 years or presence of other medical conditions) within 10 days of symptom onset and positive test for SARS-CoV-2. The primary endpoint was hospitalization and/or death through day 28. We report Phase 3 BRII-196/BRII-198 trial results per DSMB recommendation following an interim analysis. Results. Between January and July 2021, 837 participants (418 active, 419 placebo) from sites in the US (66%), Brazil, South Africa, Mexico, Argentina and the Philippines were randomized and received study product at time of emerging variants. Median age 49 years (Q1, Q3: 39, 58), 51% female, 17% Black/African-American and 49% Hispanic/Latino, with median 6 days from symptom onset. At interim analysis 71% and 97% had a day 28 and 7 visit, respectively. For all available data at interim review, BRII-196/BRII-198 compared to placebo had fewer hospitalizations (12 vs. 45) and deaths (1 vs. 9). At day 28 of follow-up, there was an estimated 78% reduction in hospitalization and/or death (2.4 vs. 11.1%), relative risk 0.22 (95% CI: 0.05, 0.86), P=0.00001 (nominal one-sided). Grade 3 or higher adverse events (AEs) were observed less frequently among BRII-196/BRII-198 participants than placebo (3.8% vs. 13.4%) with no severe infusion reactions or drug related serious AEs. Conclusion. BRII-196/BRII-198 was safe, well-tolerated, and demonstrated significant reduction compared to placebo in the risk of hospitalization and/or death among adults with mild-moderate COVID-19 at high risk for progression to severe disease.
ABSTRACT
Background: During COVID pandemic, many cancer patients (pts) refused to come to hospital, suspending therapies, with ominous consequences. Based on positive (+) results of DOMONCOVID, our homecare project for COVID+ cancer pts, we created a new model of assistance, ONCOHOME, delivering cancer care at home to immune-compromised pts. We aim to provide data on feasibility, efficacy and costs of this innovative model. Material and Methods: ONCOHOME is a multicenter project involving 3 Cancer Center (CC) of the North of Italy: National Cancer Institute, San Raffaele in Milan and Cremona CC. We created an organizational homecare model based on a medical and nursing team with a car equipped for home visits and a secretariat managing patient calls, with a dedicated phone number. The team administers cancer care at home and provides pts with the same assistance usually delivered in hospital. Patientreported outcome (PRO) assessment is performed. Results: From August 3rd 2020 to May 5th 2021, 79 cancer pts were assisted at home by Cremona team, receiving oral (62 pts), subcutaneous (10pts) or intravenous therapy (7 pts). All types of cancer were included. 77% of pts had a metastatic disease, 88% had a PS ECOG 0-1. Median duration of assistance was 126 days [range 2-270 days]. Most of the pts received oral chemotherapy (41pts). TKIs (25 pts), hormonal therapy (12 pts), supportive care with denosumab and zolendronic acid (5 pts ) and immunotherapy (1 patient, pt) were successfully administered at home, too. 13 pts required hospitalization due to clinical complications. In this group, only 2 pts were admitted to hospital due to severe toxicity;in particular, 1 pt treated with trifluridin/ tipiracil developed febrile neutropenia and 1 pt treated with gefitinib reported Grade 3 diarrhea. Both pts were discharged and continued to be assisted at home. Conclusions: ONCOHOME showed that inpatient or outpatient cancer drug administration could be successfully replaced by home administration, for appropriate therapies and selected pts. This model is feasible at an affordable cost. The project is ongoing, planning to accrue other 100 pts for each center. ONCOHOME will be implemented with electronic devices for PRO evaluation, certified telemedicine service and non-invasive wearable smart tissue monitoring physiological parameters devices.
ABSTRACT
Background: During COVID pandemic, many cancer patients (pts) refused to come to hospital, suspending therapies, with ominous consequences. Based on positive (+) results of DOMONCOVID, our homecare project for COVID+ cancer pts, we created a new model of assistance, ONCOHOME, delivering cancer care at home to immune-compromised pts. We aim to provide data on feasibility, efficacy and costs of this innovative model. Methods: ONCOHOME is a multicenter project involving 3 Cancer Center (CC) of the North of Italy: National Cancer Institute, San Raffaele in Milan and Cremona CC. We created an organizational homecare model based on a medical and nursing team with a car equipped for home visits and a secretariat managing patient calls, with a dedicated phone number. The team administers cancer care at home and provides pts with the same assistance usually delivered in hospital. Patient-reported outcome (PRO) assessment is performed. Results: From August 3rd 2020 to May 5th 2021, 79 cancer pts were assisted at home by Cremona team, receiving oral (62 pts), subcutaneous (10pts) or intravenous therapy (7 pts). All types of cancer were included. 77% of pts had a metastatic disease, 88% had a PS ECOG 0-1. Median duration of assistance was 126 days [range 2-270 days]. Most of the pts received oral chemotherapy (41pts). TKIs (25 pts), hormonal therapy (12 pts), supportive care with denosumab and zolendronic acid (5 pts ) and immunotherapy (1 patient, pt) were successfully administered at home, too. 13 pts required hospitalization due to clinical complications. In this group, only 2 pts were admitted to hospital due to severe toxicity;in particular, 1 pt treated with trifluridin/tipiracil developed febrile neutropenia and 1 pt treated with gefitinib reported Grade 3 diarrhea. Both pts were discharged and continued to be assisted at home. Conclusions: ONCOHOME showed that inpatient or outpatient cancer drug administration could be successfully replaced by home administration, for appropriate therapies and selected pts. This model is feasible at an affordable cost. The project is ongoing, planning to accrue other 100 pts for each center. ONCOHOME will be implemented with electronic devices for PRO evaluation, certified telemedicine service and non-invasive wearable smart tissue monitoring physiological parameters devices. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
ABSTRACT
Background: The province of Cremona had one of the highest incidence of COVID-19 (COV-19) infection in Italy. The pandemic determined a significant shrinkage of our healthcare resources with difficulty for many patients (pts) to be assisted in the hospital, especially for the risk of being infected. Therefore, we created a homecare project for cancer pts with the aim of reducing hospitalizations, accesses to the oncology ward and emergency room. Methods: The team was composed by oncologists and nurses from the Oncology Unit of Cremona Community Hospital, supported by a secretary with a dedicated telephone number. The assistance was provided from Monday to Saturday, 9 AM-5 PM. Cancer pts were eligible if presenting confirmed diagnosis or suggestive symptoms for COV-19. A telephonic triage was performed. Cancer pts and their cohabitants were tested with at least 2 nasopharyngeal swabs (NPS). Blood test, medical examinations and vital parameters were performed. We advised screened individuals to follow the quarantine procedures, providing them with an information leaflet. We administered oral/infusional treatments, including antiviral drugs. Results: From March 23rd to April 30th 2020, 71 cancer pts were assisted at home, with a total of 191 visits. Of the 71 pts tested with NPS, 26 resulted COV-19 positive (COV-19+). 19 of COV-19+ pts had mild symptoms;7 pts with stable vital parameters and initial pneumonia were successfully treated at home with hydroxychloroquine, antivirals and NSAIDs. 7 pts with severe symptoms were promptly hospitalized. 4 of them died, 2 due to the infection, 2 to progression disease. 52 cohabitants were screened with NPS, 28 lived with a COV-19+ cancer patient;in this subgroup, 16 resulted COV-19+. 15 of them were completely asymptomatic. Conclusions: This project demonstrated the feasibility of an innovative model based on homecare assistance for COV-19+ cancer pts with mild symptoms. This strategy, limiting the number of hospital accesses for COV-19+ pts, might be useful to contain the spread of the infection. Further studies are needed to test this strategy in COV-19 negative cancer pts. Moreover, our experience indicates a high probability of identifying asymptomatic positive individuals cohabiting with COVID+ pts. NPS screening for asymptomatic subjects is not routinely performed in Italy. There is a urgent need to extend the screening to this population.
ABSTRACT
It is imperative to ensure the safety of health-care workers in the angiographic room during the outbreak of the coronavirus disease 2019 (COVID-19). The selection criteria for interventional radiology (IR) procedures, the prepara-tion of the staff and angiographic suite, ventilation systems, and intra-and post-procedural workflow optimization methods are detailed. The specific measures needed to protect occupational safety and health may result in higher costs, longer procedural times, and greater technical problems. However, these precautions may help to minimize the spread of COVID-19 among IR practitioners. © 2020 CC BY 4.0 – in cooperation with Depts. of Cardiothoracic/ Vascular Surgery, General Surgery and Anesthesia, Örebro University Hospital and Örebro University, Sweden.