Your browser doesn't support javascript.
Show: 20 | 50 | 100
Results 1 - 5 de 5
Filter
1.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-311067

ABSTRACT

Background: Severity of illness and mortality from coronavirus disease 2019 (COVID-19) is consistently lower in women than in men. While this outcome difference is not well understood, focus on sex as a biologic factor may suggest potential therapeutic intervention for this disease. We assessed whether adding progesterone, a steroid hormone with immune-modulatory properties, to standard of care, would improve clinical outcomes of hospitalized men with moderate to severe COVID-19.Method: We conducted a Phase 1, randomised, open-label, controlled trial at a large academic hospital in Los Angeles, CA, USA, of subcutaneous progesterone in men hospitalized with confirmed COVID-19 and evidence of lower respiratory tract involvement. Patients were randomly assigned (1:1), using block randomization and a computer-generated randomization sequence, to receive standard of care (SOC) plus progesterone (100 mg subcutaneously twice daily for up to five days) or SOC alone. In addition to assessment of safety, the primary outcome was change in clinical status based on a 7-point ordinal scale noted at baseline compared to that on Day 7 of the trial. Control patients with significant clinical deterioration or absence of clinical improvement by Day 7 were permitted to cross over to receive progesterone therapy. Intention to treat analysis was performed and the patient’s last clinical assessment prior to receiving the study drug was imputed as the Day 7 assessment. Findings: Forty-two patients were enrolled in the study from April 27 to August 20, 2020;22 were randomised to the control group and 20 to the progesterone group. Of the 20 patients in the progesterone group, two withdrew from the study prior to receiving progesterone and were excluded from analysis. There was an overall improvement in clinical status from baseline to Day 7 in patients in the progesterone group as compared to controls (95% CI: 0-2;P = 0·010). There were no serious adverse events attributable to progesterone.Interpretation: Progesterone at a dose of 100 mg, twice daily by subcutaneous injection in addition to standard of care may represent a safe and novel approach for the treatment in men with moderate to severe COVID-19.Trial Registration: This trial was registered at ClinicalTrials.gov, NCT04365127.Funding Statement: The Institut Biochimique SA (IBSA, Lugano, Switzerland)Declaration of Interests: SG, YM, SP, TK, DN, JH, SC, RIG, JM, CB, ML, VT report grants and nonfinancial support from Institut Biochimique SA (IBSA, Lugano, Switzerland), during the conduct of the study;SG,SP report patent pending on method of use of progesterone agonist for treatment of COVID-19 VT reports grants from NIH/NIAID ACTT (ACTT 1-3), outside the submitted work. DS, HG declare no competing interests.Ethics Approval Statement: This study was approved by the Cedars-Sinai Institutional Review Board (IRB).

2.
J Genet Couns ; 30(5): 1214-1223, 2021 10.
Article in English | MEDLINE | ID: covidwho-1508786

ABSTRACT

The COVID-19 pandemic has significantly impacted the service delivery model (SDM) of clinical genetic counseling across the United States and Canada. A cross-sectional survey was distributed to 4,956 genetic counselors (GCs) from the American Board of Genetic Counselors and Canadian Association of Genetic Counselors mailing lists in August 2020 to assess the change in utilization of telehealth for clinical genetic counseling during the COVID-19 pandemic compared with prior to the pandemic. Data from 411 eligible clinical genetic counselors on GC attitudes and their experiences prior to and during the pandemic were collected and analyzed to explore the change in SDM, change in appointment characteristics, change in billing practices, GC perceived benefits and limitations of telehealth, and prediction of future trends in SDM in the post-pandemic era. The study showed the overall utilization of audiovisual and telephone encounters increased by 43.4% and 26.2%, respectively. The majority of respondents who provided audiovisual and telephone encounters reported increased patient volume compared with prior to the pandemic, with an average increase of 79.4% and 42.8%, respectively. There was an increase of 69.4% of GCs rendering genetic services from home offices. The percentage of participants who billed for telehealth services increased from 45.7% before the pandemic to 80.3% during the pandemic. The top GC perceived benefits of telehealth included safety for high-risk COVID patients (95.2%) and saved commute time for patients (94.7%). The top GC perceived limitations of telehealth included difficulty to conduct physician evaluation/coordinating with healthcare providers (HCP) (73.7%) and difficulty addressing non-English speaking patients (68.5%). Overall, 89.6% of GCs were satisfied with telehealth; however, 55.3% reported uncertainty whether the newly adopted SDM would continue after the pandemic subsides. Results from this study demonstrate the rapid adoption of telehealth for clinical genetic counseling services as a result of the COVID-19 pandemic, an increase in billing for these services, and support the feasibility of telehealth for genetic counseling as a longer term solution to reach patients who are geographically distant.


Subject(s)
COVID-19 , Counselors , Telemedicine , Canada , Cross-Sectional Studies , Humans , Pandemics , SARS-CoV-2 , United States
3.
Cerebrovasc Dis ; 50(6): 707-714, 2021.
Article in English | MEDLINE | ID: covidwho-1282177

ABSTRACT

OBJECTIVE: To describe the impact of COVID-19 on acute cerebrovascular disease care across 9 comprehensive stroke centers throughout Los Angeles County (LAC). METHODS: Volume of emergency stroke code activations, patient characteristics, stroke severity, reperfusion rates, treatment times, and outcomes from February 1 to April 30, 2020, were compared against the same time period in 2019. Demographic data were provided by each participating institution. RESULTS: There was a 17.3% decrease in stroke code activations across LAC in 2020 compared to 2019 (1,786 vs. 2,159, respectively, χ2 goodness of fit test p < 0.0001) across 9 participating comprehensive stroke centers. Patients who did not receive any reperfusion therapy decreased by 16.6% in 2020 (1,527) compared to 2019 (1,832). Patients who received only intravenous thrombolytic (IVT) therapy decreased by 31.8% (107 vs. 157). Patients who received only mechanical thrombectomy (MT) increased by 3% (102 vs. 99). Patients who received both IVT and MT decreased by 31.8% (45 vs. 66). Recanalization treatment times in 2020 were comparable to 2019. CSCs serving a higher proportion of Latinx populations in the eastern parts of LAC experienced a higher incidence of MT in 2020 compared to 2019. Mild increase in stroke severity was seen in 2020 compared to 2019 (8.95 vs. 8.23, p = 0.046). A higher percentage of patients were discharged home in 2020 compared to 2019 (59.5 vs. 56.1%, p = 0.034), a lower percentage of patients were discharged to skilled nursing facility (16.1 vs. 20.7%, p = 0.0004), and a higher percentage of patients expired (8.6 vs. 6.3%, p = 0.008). CONCLUSION: LAC saw a decrease in overall stroke code activations in 2020 compared to 2019. Reperfusion treatment times remained comparable to prepandemic metrics. There has been an increase in severe stroke incidence and higher volume of thrombectomy treatments in Latinx communities within LAC during the pandemic of 2020. More patients were discharged home, less patients discharged to skilled nursing facilities, and more patients expired in 2020, compared to the same time frame in 2019.


Subject(s)
Brain Ischemia/epidemiology , COVID-19 , Fibrinolytic Agents/adverse effects , Ischemic Stroke , Stroke/therapy , Thrombolytic Therapy , Brain Ischemia/diagnosis , Brain Ischemia/therapy , Humans , Los Angeles/epidemiology , Retrospective Studies , SARS-CoV-2 , Stroke/diagnosis , Stroke/epidemiology , Thrombectomy , Time-to-Treatment , Treatment Outcome
4.
Chest ; 160(1): 74-84, 2021 07.
Article in English | MEDLINE | ID: covidwho-1258346

ABSTRACT

BACKGROUND: Severity of illness in COVID-19 is consistently lower in women. A focus on sex as a biological factor may suggest a potential therapeutic intervention for this disease. We assessed whether adding progesterone to standard of care (SOC) would improve clinical outcomes of hospitalized men with moderate to severe COVID-19. RESEARCH QUESTION: Does short-term subcutaneous administration of progesterone safely improve clinical outcome in hypoxemic men hospitalized with COVID-19? STUDY DESIGN AND METHODS: We conducted a pilot, randomized, open-label, controlled trial of subcutaneous progesterone in men hospitalized with confirmed moderate to severe COVID-19. Patients were randomly assigned to receive SOC plus progesterone (100 mg subcutaneously twice daily for up to 5 days) or SOC alone. In addition to assessment of safety, the primary outcome was change in clinical status on day 7. Length of hospital stay and number of days on supplemental oxygen were key secondary outcomes. RESULTS: Forty-two patients were enrolled from April 2020 to August 2020; 22 were randomized to the control group and 20 to the progesterone group. Two patients from the progesterone group withdrew from the study before receiving progesterone. There was a 1.5-point overall improvement in median clinical status score on a seven-point ordinal scale from baseline to day 7 in patients in the progesterone group as compared with control subjects (95% CI, 0.0-2.0; P = .024). There were no serious adverse events attributable to progesterone. Patients treated with progesterone required three fewer days of supplemental oxygen (median, 4.5 vs 7.5 days) and were hospitalized for 2.5 fewer days (median, 7.0 vs 9.5 days) as compared with control subjects. INTERPRETATION: Progesterone at a dose of 100 mg, twice daily by subcutaneous injection in addition to SOC, may represent a safe and effective approach for treatment in hypoxemic men with moderate to severe COVID-19. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT04365127; URL: www.clinicaltrials.gov.


Subject(s)
COVID-19 , Progesterone/administration & dosage , SARS-CoV-2/isolation & purification , COVID-19/physiopathology , COVID-19/therapy , Clinical Protocols/standards , Drug Monitoring , Humans , Hypoxia/diagnosis , Hypoxia/etiology , Injections, Subcutaneous , Male , Middle Aged , Oxygen Inhalation Therapy/methods , Pilot Projects , Progestins/administration & dosage , Severity of Illness Index , Treatment Outcome
SELECTION OF CITATIONS
SEARCH DETAIL