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1.
Chinese Pharmaceutical Journal ; 57(10):845-850, 2022.
Article in Chinese | EMBASE | ID: covidwho-1918126

ABSTRACT

OBJECTIVE: To review the mechanism and the clinical research progress of nirmatrelvir tablets/ritonavir tablets(PaxlovidTM), so as to provide references for its rational usage. METHODS: Literatures related to nirmatrelvir tablets/ritonavir tablets in the official website of US Food and Drug Administration, Pubmed, Embase, CNKI, CBM and Wanfang were systematically searched. The basic information, mechanism of action, pharmacokinetics, pharmacodynamics, clinical efficacy evaluation, safety, drug interaction, drug use in special populations were reviewed. RESULTS AND CONCLUSIONS: Nirmatrelvir tablets/ritonavir tablets inhibit the replication of SARS-COV-2 virus by inhibiting the processing of SARS-CoV-2 protein precursor mediated by the main protease. Based on current trial results, nirmatrelvir tablets/ritonavir tablets can significantly reduce hospitalization and mortality rates in adult patients with mild and moderate COVID-19. More research is required to determine whether the drug is appropriate for the clinical treatment of all COVID-19 patients.

2.
SSRN; 2022.
Preprint in English | SSRN | ID: ppcovidwho-333417

ABSTRACT

Background: The complement system plays a role in hyperinflammation due to COVID-19, and C1 esterase inhibitor (C1-INH) is a key inhibitor. Recombinant human C1-INH (rhC1-INH) treatment could impact the clinical course by limiting this hyperinflammatory response. This trial evaluated if rhC1-INH + COVID-19 standard of care (SOC) administered early during hospitalization could positively impact the clinical course. Methods: In a phase 2, open-label trial in adults hospitalized with COVID-19, patients were randomized (2:1) to rhC1-INH 50 U/kg (maximum, 4200 U) every 12 hours for 4 days + SOC or SOC alone. The primary endpoint was Day 7 clinical status (World Health Organization scale). Results: Thirty-eight patients (rhC1-INH + SOC [n=27];SOC alone [n=11]) were included, with a significant difference at Day 7 favoring rhC1-INH + SOC for percentage of patients by clinical status (p=0.002). No patients in rhC1INH + SOC group and 2/11 (18.2%) in SOC alone group were admitted to intensive care unit. In rhC1-INH + SOC group, 26/27 patients (96.3%) had ≥1 level improvement in clinical status versus 8/11 patients (72.7%) in SOC alone group (p = 0.03);no clinical status deterioration was observed in rhC1-INH + SOC group. Interleukin-6 and C-reactive protein levels in rhC1-INH + SOC group remained low versus substantial elevations in SOC alone group. Most common adverse events in rhC1-INH + SOC group included transaminitis, dyspnea, and hypertension. One death occurred in SOC alone group. Conclusion: These data support that early treatment with rhC1INH + SOC provided clinical benefit to hospitalized patients with COVID-19.

3.
Chinese Journal of New Drugs ; 31(1):69-76, 2022.
Article in Chinese | Scopus | ID: covidwho-1661512

ABSTRACT

As of May 2021, 6 new vaccines against coronavirus disease 2019 (COVID-19) have been conditionally approved and urgently used in China, including products of 4 new inactivated vaccines, 1 new adenovirus vaccine and 1 new recombinant vaccine. All the six vaccine products have been under different stages of clinical trials in global scale, and the results of the clinical trials have demonstrated the safety of the vaccines and the efficacy against COVID-19. Focusing on the above products, this paper deeply summarizes the characteristics of different new vaccine products and the clinical trial results as the key evidence supporting the approval of the products. In addition, facing the current severe situation of COVID-19, the status and challenges regarding the research and development of new vaccines and therapeutics are analyzed. © 2022, Chinese Journal of New Drugs Co. Ltd. All right reserved.

4.
Circulation ; 143(SUPPL 1), 2021.
Article in English | EMBASE | ID: covidwho-1325214

ABSTRACT

Introduction: Chronic stress is associated with incident hypertension and is a promising intervention target for lowering blood pressure (BP), particularly in women. Growing evidence suggests that mindfulness-based interventions can reduce BP and improve psychological outcomes but the in-person format of traditional programs limits access. The goal of this study was to evaluate the feasibility, acceptability and effects of telephone-delivered mindfulness-based cognitive therapy (MBCT-T) in women with prehypertension. Methods: We conducted a pilot RCT in which 37 women meeting JNC 7 criteria for prehypertension (SBP 120-139 mmHg or DBP 80-89 mmHg) and not taking antihypertensive medication were recruited from outpatient clinics or via the EHR. Eligible participants were randomized to usual care or MBCT-T, which involved 8 weekly 1-hour phone sessions delivered to small groups by a trained instructor. Outcomes included feasibility (session completion), acceptability (Client Satisfaction Questionnaire [CSQ]), SBP (mean of 3 clinic BP measurements), perceived stress (PSS-10) and depressive symptoms (PHQ-8). Linear mixed models with a random effect of intervention cohort were performed to compare 3-month changes in outcomes between study arms, adjusting for age and ethnicity. Results: The mean age was 50.7±17.7, 68% of participants were racial/ethnic minorities, and baseline SBP/DBP was 127.8±6.2/77.5±7.2 mmHg. There were no significant differences between study arms in demographics or baseline characteristics. The median number of sessions completed was 6 of 8. Fewer sessions were completed by employed vs. unemployed women (4.5 vs. 7.8,t=3.55, p=.003) and by foreign-born vs. U.S.-born women (2.8 vs. 5.9, t=1.87, p=.08). Overall 3-month retention was 89% but follow-up BP was missing in ∼50% of participants due to COVID-19research restrictions. Three-quarters of MBCT-T participants reported high satisfaction with theintervention (CSQ24). In the subgroup with complete follow-up data, SBP declined in both studyarms but there was no significant between-group difference (p=0.51). Conversely, greater reductionsin perceived stress and depressive symptoms were observed in the MBCT-T arm vs. usual care(between-group differences of 3.63 [PSS-10;p=.163] and 2.90 [PHQ-8;p=.008]). In per-protocolanalyses limited to MBCT-T participants who completed ≥4 sessions, effects were larger forperceived stress and similar for depressive symptoms (between-group differences of 6.17 [PSS-10;p=.012] and 2.77 [PHQ-8;p=.025]). Conclusions: Results support the feasibility and acceptability of telephone-based mindfulnesstraining in diverse women with prehypertension. Promising findings for stress and depressivesymptoms suggest further studies are warranted. Strategies to address barriers to participation, particularly among working women and minorities, are needed.

5.
Kexue Tongbao/Chinese Science Bulletin ; 66(9):980-986, 2021.
Article in Chinese | Scopus | ID: covidwho-1175360
6.
Wool Textile Journal ; 48(12):98-102, 2020.
Article in Chinese | Scopus | ID: covidwho-1168307
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