scholarly journals Social and Clinical Impact of COVID-19 on Patients with Fibrodysplasia Ossificans Progressiva

2021 ◽  
Author(s):  
Samuel Kou ◽  
Sammi Kile ◽  
Sai Samhith Kambampati ◽  
Evelyn C. Brady ◽  
Hayley Wallace ◽  
...  
Keyword(s):  
High Risk ◽  
Sample Size ◽  
Genetic Disorder ◽  
Fibrodysplasia Ossificans Progressiva ◽  
Flare Activity ◽  
Social Activities ◽  
Physician Visits ◽  
Major Complications ◽  
Patient Reported ◽  
The Impact

Abstract Background COVID-19, caused by the SARS-CoV-2 virus, is a severe inflammatory condition. Patients with pre-existing conditions including diabetes, hypertension, and cardiovascular disease are at particularly high risk of complications. Fibrodysplasia ossificans progressiva (FOP) is an ultra-rare and debilitating genetic disorder that is characterized by a pro-inflammatory state, which leads to progressive heterotopic ossification and complications after trauma, including intramuscular vaccinations. To better understand the impact of COVID-19 on patients with FOP, we first examined the social impact of the pandemic using data from the FOP Registry managed by the International FOP Association. We also identified patients with FOP who were exposed to or contracted the SARS-CoV-2 virus, or who received a COVID-19 vaccine, to investigate if patients with FOP were at increased risks of complications from SARS-CoV2 exposure. Results Data from 326 individuals in 69 countries were examined in the International FOP Association FOP Connection Registry using patient-reported outcomes measurement information system (PROMIS) global health scale scores. Twenty-six (28.9%) participants aged ≥ 15 years old rated their satisfaction with their social activities and relationships as poor in 2020, which was an increase from 18 (18.9%) in 2019, prior to the SARS-CoV-2 outbreak. Similar trends were noted for physical and mental health in the pediatric population. Frequency of physician visits was not changed, but a larger portion of patients reported missing dental visits in 2020 compared with 2019 (31.5% vs. 41.7%). A second cohort with 32 subjects was tracked after SARS-CoV-2 exposure or vaccination. Ten subjects were positively diagnosed with COVID-19, 15 received a COVID-19 vaccine, and seven had high-risk SARS-CoV-2 exposure but either did not have a confirmed clinical diagnosis or tested negative. Subjects who tested positive for the virus showed no major complications or increased FOP disease activity, though our sample size is very limited. Among the 15 subjects who received a COVID-19 vaccine, using the International Clinical Council on FOP guidelines for prophylaxis with ibuprofen or acetaminophen, only one person experienced flare activity at the injection site. Conclusions Patients with FOP showed a significant decrease in social activities that was reflective of the isolation and mobility changes in this debilitated population. In our limited cohort, the majority of the patients with FOP who tested positive for COVID-19 showed no major complications. Also, although limited in sample size, the majority of patients who received a COVID-19 vaccination and followed guidelines from the FOP International Clinical Council tolerated vaccination well. Only one person experiencing flare activity following their injection. Thus, the risks and benefits of COVID-19 vaccination needs to be discussed carefully so as to support informed decisions.

P23 MALNUTRITION INDICES AS PROGNOSTIC FACTORS FOR POSTOPERATIVE COMPLICATIONS IN ESOPHAGEAL CANCER PATIENTS

2019 ◽  
Vol 32 (Supplement_2) ◽  
Author(s):  
Lidoriki Irene ◽  
Schizas Dimitrios ◽  
Mpaili Efstratia ◽  
Mpoura Maria ◽  
Hasemaki Natasha ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Prognostic Factors ◽  
High Risk ◽  
Postoperative Complications ◽  
Anastomotic Leakage ◽  
Cancer Patients ◽  
Preoperative Assessment ◽  
Low Risk ◽  
Major Complications ◽  
The Impact

Abstract Aim To investigate the impact of malnutrition on postoperative complications in esophageal cancer patients. Background and Methods Malnutrition is common in esophageal cancer patients due to the debilitating nature of their disease. Several methods of nutritional assessment have emerged as significant prognostic factors for short-and long-term outcomes in patients operated for esophageal cancer. The study sample consisted of 85 patients with esophageal (n=11) and gastroesophageal junction (n=74) cancer who were admitted for surgery in the First Department of Surgery, Laikon General Hospital, Athens, Greece, between September 2015 and March 2019. Out of them, 65 patients underwent esophagectomy, while 20 patients underwent total gastrectomy. The assessment of nutritional status included the Geriatric Nutritional Risk Index (GNRI), the Patient Generated Subjective Global Assessment (PG-SGA) and sarcopenia. GNRI was based on preoperative values of patients’ serum albumin and body weight. The preoperative assessment of sarcopenia was based on Skeletal Muscle Index (SMI) derived from analysis of CT scans using SliceOmatic® Software version 4.3 (Tomovision, Montreal, Canada). Postoperative complications were graded according to Clavien-Dindo classification. Minor complications included categories I-II, whereas major complications included categories III-V. Results Thirty nine patients (47.6%) developed postoperative complications. More specifically, 21 patients (24.7%) developed minor complications and 18 patients (21.2%) developed major complications, while anastomotic leakage occurred in 10 patients (11.8%). Eighty patients (94.1%) had a high-risk GNRI (<92), while 5 patients (5.9%) had a low-risk GNRI (≥92). Forty four patients (51.8%) were diagnosed with sarcopenia. The mean PG-SGA score was 8.82 ± 5.57. Patients with a high-risk GNRI demonstrated significantly higher rate of overall complications compared to low-risk GNRI patients (100% vs 44.2%, p<0.05 respectively). Moreover, the rate of anastomotic leakage was significantly higher in the sarcopenia group than in the non-sarcopenia group (29% vs 3.4%, p<0.05). Nonetheless, PG-SGA was not significantly associated with postoperative outcomes. Conclusion Higher-risk scores on the GNRI are associated with an increased risk for developing postoperative complications, while sarcopenia is associated with higher risk for anastomotic leakage among esophageal cancer patients. Preoperative assessment of GNRI and sarcopenia should be performed in all patients in order to detect patients who are at greater risk of postoperative morbidity.

Prospective randomized trial of genomic classifier impact on treatment decisions in patients at high risk of recurrence following radical prostatectomy (G-MINOR).

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. TPS154-TPS154 ◽  
Author(s):  
Todd Matthew Morgan ◽  
David Christopher Miller ◽  
Rodney Dunn ◽  
Linsell Susan ◽  
Linda Okoth ◽  
...  
Keyword(s):  
High Risk ◽  
Radical Prostatectomy ◽  
Treatment Decisions ◽  
Risk Of Recurrence ◽  
Clinical Center ◽  
Patient Reported ◽  
Impact On Treatment ◽  
The Impact

TPS154 Background: Approximately 30% of patients will have ≥pT3 disease and/or positive surgical margins at radical prostatectomy (RP), indicating a high risk of local recurrence. While current guidelines recommend consideration of adjuvant radiotherapy (aRT) in this setting, < 10% undergo aRT. The Decipher assay is a novel, tissue-based genomic classifier (GC) developed and validated in the post-RP setting as a predictor of metastasis. Current retrospective evidence suggests that patients with a high GC score may benefit from aRT, while observation may be safe for those with a lower GC score. However, there are no randomized prospective data evaluating the clinical utility of biomarkers in men with adverse features after RP. Here we see to determine the impact of GC test results on adjuvant treatment decisions for high-risk post-RP patients vs. clinical factors alone. Methods: Genomics in Michigan ImpactiNg Observation or Radiation (G-MINOR) is a 4-year (12-month enrollment, 3-year follow-up) prospective, cluster-crossover, unblinded, study of 350 subjects from twelve Urology practices in the Michigan Urological Surgery Improvement Collaborative (MUSIC). MUSIC is a physician-led quality improvement consortium nearly all academic and community urology practices within the state of Michigan. Each clinical center participating in this trial will be randomly assigned to either a Genomic Classifier (GC)-based strategy or control arm for a period of 3 months. Patients in both arms will receive a predicted risk of recurrence based on a validated clinical nomogram, the CAPRA-S score, enabling a head-to-head comparison of the Decipher assay with a freely-available validated prognostic tool. Random assignments will be generated centrally by a study statistician and provided to centers immediately before commencing enrollment in each 3-month period. Each center will have two GC and two UC enrollment periods, maintaining study-wide balance and blinding of assignments in subsequent periods. Patients will be followed for receipt of adjuvant therapy as well as oncologic (recurrence, metastasis, and death) and patient-reported quality of life. Clinical trial information: NCT02783950.

scholarly journals Patient-reported outcome scores underestimate the impact of major complications in patients undergoing spine surgery for degenerative conditions

2017 ◽  
Vol 27 (4) ◽  
pp. 397-402 ◽  
Author(s):  
Borys V. Gvozdyev ◽  
Leah Y. Carreon ◽  
Christopher M. Graves ◽  
Stephanie A. Riley ◽  
Katlyn E. McGraw ◽  
...  
Keyword(s):  
Health Status ◽  
Spine Surgery ◽  
General Health ◽  
Major Complication ◽  
Adverse Outcomes ◽  
General Health Status ◽  
Major Complications ◽  
Significant Difference ◽  
Patient Reported ◽  
The Impact

OBJECTIVEPatient-reported outcomes (PROs) such as the Oswestry Disability Index (ODI) and EuroQol-5D (EQ-5D) are widely used to evaluate treatment outcomes following spine surgery for degenerative conditions. The goal of this study was to use the Charlson Comorbidity Index (CCMI) as a measure of general health status, for comparison with standard PROs.METHODSThe authors examined serial CCMI scores, complications, and PROs in 371 patients treated surgically for degenerative lumbar spine conditions who were enrolled in the Quality and Outcomes Database from a single center. The cohort included 152 males (41%) with a mean age of 58.7 years. Patients with no, minor, or major complications were compared at baseline and at 1 year postoperatively.RESULTSMinor complications were observed in 177 patients (48%), and major complications in 34 (9%). There were no significant differences in preoperative ODI, EQ-5D, or CCMI among the 3 groups. At 1 year, there was a significantly greater deterioration in CCMI in the major complication group (1.03) compared with the minor (0.66) and no complication groups (0.44, p < 0.006), but no significant difference in ODI or EQ-5D.CONCLUSIONSDespite equivalent improvements in PROs, patients with major complications actually had greater deterioration in their general health status, as evidenced by worse CCMI scores. Because CCMI is predictive of medical and surgical risk, patients who sustained a major complication now carry a greater likelihood of adverse outcomes with future interventions, including subsequent spine surgery. Although PRO scores are a key metric, they fail to adequately reflect the potential long-term impact of major perioperative complications.

scholarly journals MP60-07 DETERMINING THE IMPACT OF GENOMIC CLASSIFIER TESTING ON PATIENT-REPORTED QUALITY OF LIFE IN MEN AT HIGH-RISK OF POST-PROSTATECTOMY RECURRENCE: RESULTS FROM THE G-MINOR TRIAL

2021 ◽  
Vol 206 (Supplement 3) ◽  
Author(s):  
Udit Singhal ◽  
Jake Quarles ◽  
Daniel Spratt ◽  
Linda Okoth ◽  
Stephanie Daignault-Newton ◽  
...  
Keyword(s):  
Quality Of Life ◽  
High Risk ◽  
Patient Reported ◽  
The Impact

Impact of decipher test on adjuvant and salvage treatments received following radical prostatectomy.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 112-112 ◽  
Author(s):  
John L. Gore ◽  
Marguerite Du Plessis ◽  
Darlene Dai ◽  
Kasra Yousefi ◽  
Darby Thompson ◽  
...  
Keyword(s):  
High Risk ◽  
Radical Prostatectomy ◽  
Decisional Conflict ◽  
P Value ◽  
Salvage Radiation Therapy ◽  
Recommended Treatment ◽  
Patient Reported ◽  
The Us ◽  
Psa Progression ◽  
The Impact

112 Background: Prostate cancer (PC) patients and providers have tremendous uncertainty as they decide on intervention with adjuvant or salvage radiation therapy (ART, SRT) after radical prostatectomy (RP). We prospectively evaluated the impact of Decipher test, a genomic classifier which predicts metastasis post-RP, on providers’ decision-making for ART and SRT. Methods: 150 men considering ART and 115 men considering SRT from 19 sites across the US were enrolled. Participating providers submitted a management recommendation prior to processing the Decipher test and again after receiving test results. We then followed patients for 12 months to assess actual treatment received and patient reported decisional conflict scale (DCS) and a validated survey on PC-related anxiety. Results: Pre-Decipher, observation was recommended for 89% of adjuvant men and 58% of salvage men. Post-Decipher, 17% of treatment recommendations changed in the adjuvant arm and 30% of recommendations changed in the salvage arm. Among adjuvant men, 78% maintained their recommended management 12 months after Decipher; 76% of salvage men maintained their recommended treatment after Decipher. Among 21 adjuvant men who intensified their treatment (observation to ART or ART to ART plus androgen deprivation therapy), 5 (24%) experienced biochemical recurrence with detectable PSA. In adjuvant men, PC-specific anxiety decreased differently among Decipher risk categories (p-value = 0.045), most notably among Decipher high risk men (9.07 [7.87, 10.26] pre-Decipher, 5.61 [5.35,5.88] 12 months post-Decipher). In salvage men, PC-specific anxiety decreased differently among those whose treatment were concordant (10.28 [8.1,12.47] pre-Decipher, 7.18 [6.82,7.54] 12 months post-Decipher) and those whose treatment were intensified (p-value = 0.01), and decreased differently among low-risk and high-risk Decipher patients (p = 0.04). Conclusions: Use of the Decipher test changed treatment decisions that was consistent with the eventual treatment received in three-fourths of adjuvant and salvage men after RP. Several men that pursued ART experienced PSA progression. PC-specific anxiety decreased in both adjuvant and salvage men. Clinical trial information: NCT02080689.

Phase II trial enzalutamide and androgen deprivation therapy (ADT) with salvage radiation in men with high-risk PSA recurrent prostate cancer (PC): The STREAM trial.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 29-29 ◽  
Author(s):  
Andrew J. Armstrong ◽  
Rhonda L. Bitting ◽  
Patrick Healy ◽  
Daniel J. George ◽  
Sung Kim ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
High Risk ◽  
Primary Endpoint ◽  
Hormonal Therapy ◽  
External Beam Radiotherapy ◽  
Patient Reported ◽  
Psa Recurrence ◽  
The Impact ◽  
Over Time

29 Background: Salvage external beam radiotherapy (RT) and hormonal therapy improves survival over RT alone in men with non-metastatic hormone naïve PC and PSA recurrence after radical prostatectomy (RP). We investigated the safety/efficacy of enzalutamide with salvage RT and ADT in this setting. Methods: This was a 3 center prospective phase 2 single arm clinical trial in the Dept of Defense Prostate Cancer Clinical Trials Consortium. Eligibility: Gleason 7-10 PC and PSA recurrence within 4 years (yrs) of RP, PSA 0.2-4.0, no prior hormonal therapy, and no metastases on CT/Bone Scan imaging. Men received 6 months (mos) of ADT with 160 mg/d enzalutamide and 66 Gy RT to the prostate bed. Primary endpoint was 2 yr PFS with testosterone (T) recovery to >100 ng/dl. Secondary objectives included PSA nadir, 3 yr PFS, safety and patient reported quality-of-life over time. This trial was designed with 84% power to detect a 20% improvement in 2 yr PFS vs historic data and a 1-sided alpha of 0.05. Results: We enrolled 38 men (90% white, 8% black, 2% Asian); 37 (97%) completed therapy and were evaluable with T recovery at 2 yrs. Median age was 64 yrs; 47% Gleason 8-10, 79% T3/T4 disease, 21% had resected N+ PC; median PSA was 0.4 (0.19-4.19). Median follow-up is 29.5 mo. Treatment was well tolerated with 11 patients (29%) experiencing G3 toxicities (including 4 HTN, 2 urinary retention, 2 CV events); no G4-5 or unexpected toxicities were observed. T recovery occurred in 35 (95%) at 12 mos. The primary endpoint of 2 yr PFS was 65% (95% CI: 47%-78% vs. historic controls with 51% 2 yr PFS rate) among the 37 patients with T recovery. PSA remained at undetectable levels in 69% at 2 yrs. The 3 yr PFS was 53% (95% CI: 36%, 68%). QOL data over time suggest short term reductions in urinary and sexual function with recovery by 12-24 mo in most men. Conclusions: Salvage enzalutamide and ADT for 6 months with RT following RP for men with PSA recurrent high risk PC is safe, and demonstrates encouraging efficacy at 2 and 3 years. Most men have testosterone recovery at 1 year. These data warrant prospective controlled phase 3 trials to assess the impact of potent AR inhibition in this curative intent setting. Clinical trial information: NCT02057939.

scholarly journals Post-exposure Prophylaxis Against SARS-CoV-2 in Close Contacts of Confirmed COVID-19 Cases (CORIPREV): Study Protocol for a Cluster-randomised Trial

2020 ◽  
Author(s):  
Darrell Tan ◽  
Adrienne K. Chan ◽  
Peter Jüni ◽  
George Tomlinson ◽  
Nick Daneman ◽  
...  
Keyword(s):  
High Risk ◽  
Sample Size ◽  
Randomised Trial ◽  
Sample Size Calculation ◽  
Risk Exposure ◽  
Cluster Randomised Trial ◽  
Post Exposure Prophylaxis ◽  
Post Exposure ◽  
Exposure Prophylaxis ◽  
The Impact

Abstract Background: Post-exposure prophylaxis (PEP) is a well-established strategy for the prevention of infectious diseases, in which recently exposed people take a short course of medication to prevent infection. The primary objective of the COVID-19 Ring-based Prevention Trial with lopinavir/ritonavir (CORIPREV-LR) is to evaluate the efficacy of a 14-day course of oral lopinavir/ritonavir as PEP against COVID-19 among individuals with a high-risk exposure to a confirmed case.Methods: This is an open-label, multicenter, 1:1 cluster-randomized trial of LPV/r versus no intervention, using an adaptive approach to sample size calculation. Participants will be individuals aged >6 months with a high-risk exposure to a confirmed COVID-19 case within the past 7 days. A combination of remote and in-person study visits at days 1, 7, 14, 35 and 90 include comprehensive epidemiological, clinical, microbiologic and serologic sampling. The primary outcome is microbiologically confirmed COVID-19 infection within 14 days after exposure, defined as a positive respiratory tract specimen for SARS-CoV-2 by polymerase chain reaction. Secondary outcomes include safety, symptomatic COVID-19, seropositivity, hospitalization, respiratory failure requiring ventilator support, mortality, psychological impact, and health-related quality of life. Additional analyses will examine the impact of LPV/r on these outcomes in the subset of participants who test positive for SARS-CoV-2 at baseline. To detect a relative risk reduction of 40% with 80% power at α=0.05, assuming p0=15%, 5 contacts per case and intra-class correlation coefficient (ICC)=0.05, we require 110 clusters per arm, or 220 clusters overall and approximately 1220 enrollees after accounting for 10% loss-to-follow-up. We will modify the sample size target after 60 clusters, based on preliminary estimates of p0, ICC and cluster size and consider switching to an alternative drug after interim analyses and as new data emerges. The primary analysis will be a generalized linear mixed model with logit link to estimate the effect of LPV/r on the probability of infection. Discussion: Harnessing safe, existing drugs such as LPV/r as PEP could provide an important tool for control of the COVID-19 pandemic. Novel aspects of our design include the ring-based prevention approach, and the incorporation of remote strategies for conducting study visits and biospecimen collection.Trial registration: This trial was registered at www.clinicaltrials.gov (NCT04321174) on March 25, 2020. https://clinicaltrials.gov/ct2/show/NCT04321174

scholarly journals Impact of the COVID-19 pandemic on biopsychosocial health and quality of life among Danish children and adults with neuromuscular diseases (NMD)—Patient reported outcomes from a national survey

PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0253715
Author(s):  
Charlotte Handberg ◽  
Ulla Werlauff ◽  
Ann-Lisbeth Højberg ◽  
Lone F. Knudsen
Keyword(s):  
Quality Of Life ◽  
High Risk ◽  
Negative Impact ◽  
Neuromuscular Diseases ◽  
Social Contact ◽  
Severe Illness ◽  
Patient Reported ◽  
Biopsychosocial Health ◽  
The Impact

The purpose was to investigate the impact of the COVID-19 pandemic on biopsychosocial health, daily activities, and quality of life among children and adults with neuromuscular diseases, and to assess the prevalence of COVID-19 infection and the impact of this in patients with neuromuscular diseases. The study was a national questionnaire survey. Responses were obtained from 811 adults (29%) and 67 parents of children (27%) with neuromuscular diseases. Many patients reported decreased health or physical functioning, and changes in access to physiotherapy or healthcare due to the pandemic. Participants generally perceived themselves or their child to be at high risk of severe illness from COVID-19, but only 15 patients had suffered from COVID-19 and experienced mild flu-like symptoms. 25.3% of adults and 46.6% of parents experienced anxiety. 20.4% of adults and 27.6% of parents experienced symptoms of depression. In general, the pandemic contributed to anxiety, a depressed mood as well as to fewer leisure activities, less social contact, isolation from work/school and a reduced quality of life, in particular for patients who perceived themselves to be at high risk of severe illness. The results demonstrate that the pandemic has had a negative impact on biopsychosocial health and quality of life of patients with neuromuscular diseases.

scholarly journals Post-exposure prophylaxis against SARS-CoV-2 in close contacts of confirmed COVID-19 cases (CORIPREV): study protocol for a cluster-randomized trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Darrell H. S. Tan ◽  
Adrienne K. Chan ◽  
Peter Jüni ◽  
George Tomlinson ◽  
Nick Daneman ◽  
...  
Keyword(s):  
High Risk ◽  
Randomized Trial ◽  
Sample Size ◽  
Cluster Randomized Trial ◽  
Risk Exposure ◽  
Post Exposure Prophylaxis ◽  
Primary Analysis ◽  
Cluster Randomized ◽  
Exposure Prophylaxis ◽  
The Impact

Abstract Background Post-exposure prophylaxis (PEP) is a well-established strategy for the prevention of infectious diseases, in which recently exposed people take a short course of medication to prevent infection. The primary objective of the COVID-19 Ring-based Prevention Trial with lopinavir/ritonavir (CORIPREV-LR) is to evaluate the efficacy of a 14-day course of oral lopinavir/ritonavir as PEP against COVID-19 among individuals with a high-risk exposure to a confirmed case. Methods This is an open-label, multicenter, 1:1 cluster-randomized trial of LPV/r 800/200 mg twice daily for 14 days (intervention arm) versus no intervention (control arm), using an adaptive approach to sample size calculation. Participants will be individuals aged > 6 months with a high-risk exposure to a confirmed COVID-19 case within the past 7 days. A combination of remote and in-person study visits at days 1, 7, 14, 35, and 90 includes comprehensive epidemiological, clinical, microbiologic, and serologic sampling. The primary outcome is microbiologically confirmed COVID-19 infection within 14 days after exposure, defined as a positive respiratory tract specimen for SARS-CoV-2 by polymerase chain reaction. Secondary outcomes include safety, symptomatic COVID-19, seropositivity, hospitalization, respiratory failure requiring ventilator support, mortality, psychological impact, and health-related quality of life. Additional analyses will examine the impact of LPV/r on these outcomes in the subset of participants who test positive for SARS-CoV-2 at baseline. To detect a relative risk reduction of 40% with 80% power at α = 0.05, assuming the secondary attack rate in ring members (p0) = 15%, 5 contacts per case and intra-class correlation coefficient (ICC) = 0.05, we require 110 clusters per arm, or 220 clusters overall and approximately 1220 enrollees after accounting for 10% loss-to-follow-up. We will modify the sample size target after 60 clusters, based on preliminary estimates of p0, ICC, and cluster size and consider switching to an alternative drug after interim analyses and as new data emerges. The primary analysis will be a generalized linear mixed model with logit link to estimate the effect of LPV/r on the probability of infection. Participants who test positive at baseline will be excluded from the primary analysis but will be maintained for additional analyses to examine the impact of LPV/r on early treatment. Discussion Harnessing safe, existing drugs such as LPV/r as PEP could provide an important tool for control of the COVID-19 pandemic. Novel aspects of our design include the ring-based prevention approach, and the incorporation of remote strategies for conducting study visits and biospecimen collection. Trial registration This trial was registered at www.ClinicalTrials.gov (NCT04321174) on March 25, 2020.

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