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1.
Trials ; 23(1), 2022.
Article in English | EuropePMC | ID: covidwho-2034045

ABSTRACT

Introduction At present, vaccines form the only mode of prophylaxis against COVID-19. The time needed to achieve mass global vaccination and the emergence of new variants warrants continued research into other COVID-19 prevention strategies. The severity of COVID-19 infection is thought to be associated with the initial viral load, and for infection to occur, viruses including SARS-CoV-2 must first penetrate the respiratory mucus and attach to the host cell surface receptors. Carrageenan, a sulphated polysaccharide extracted from red edible seaweed, has shown efficacy against a wide range of viruses in clinical trials through the prevention of viral entry into respiratory host cells. Carrageenan has also demonstrated in vitro activity against SARS-CoV-2. Methods and analysis A single-centre, randomised, double-blinded, placebo-controlled phase III trial was designed. Participants randomised in a 1:1 allocation to either the treatment arm, verum Coldamaris plus (1.2 mg iota-carrageenan (Carragelose®), 0.4 mg kappa-carrageenan, 0.5% sodium chloride and purified water), or placebo arm, Coldamaris sine (0.5% sodium chloride) spray applied daily to their nose and throat for 8 weeks, while completing a daily symptom tracker questionnaire for a total of 10 weeks. Primary outcome Acquisition of COVID-19 infection as confirmed by a positive PCR swab taken at symptom onset or seroconversion during the study. Secondary outcomes include symptom type, severity and duration, subsequent familial/household COVID-19 infection and infection with non-COVID-19 upper respiratory tract infections. A within-trial economic evaluation will be undertaken, with effects expressed as quality-adjusted life years. Discussion This is a single-centre, phase III, double-blind, randomised placebo-controlled clinical trial to assess whether carrageenan nasal and throat spray reduces the risk of development and severity of COVID-19. If proven effective, the self-administered prophylactic spray would have wider utility for key workers and the general population. Trial registration NCT04590365;ClinicalTrials.gov NCT04590365. Registered on 19 October 2020. Supplementary Information The online version contains supplementary material available at 10.1186/s13063-022-06685-z.

2.
Team Performance Management ; : 16, 2022.
Article in English | Web of Science | ID: covidwho-1853405

ABSTRACT

Purpose Organizations worldwide use virtual teams to cope with the COVID-19 pandemic and capitalize on distributed members' unique expertise to accomplish essential tasks. A critical reason that inhibits virtual team members from leveraging each other's knowledge is a lack of psychological safety. Specifically, individuals are unwilling to speak out for fear of negative repercussions, such as embarrassment to one's image and rejection from others in their teams. The purpose of this study is to advance the importance of distinct awareness (task knowledge and presence) enabled by information technologies in developing the psychological safety of men and women in virtual teams. Design/methodology/approach This study tested the hypotheses using a survey study of 94 participants from 19 graduate student virtual teams. Findings This study found that task knowledge awareness predicted psychological safety for men, whereas it was presence awareness for women. By demonstrating the role of awareness in promoting psychological safety for men and women in virtual teams, this study also sheds light on reducing online gender inequitable issues. Practical implications First, organizational managers need to incorporate gender when deciding the awareness type to promote psychological safety in virtual teams. For men, it is task knowledge awareness, whereas for women, it is presence awareness. Second, as there is a wide range of information technologies (ITs) available, managers need to identify if the provided ITs enable virtual team members to develop the specific type of knowledge awareness critical for psychological safety development. Third, managers can incorporate rewards and apply interventions at regular temporal periods to encourage team members to increase their online presence as well as question and share task-related content. Originality/value It is imperative to identify ways to encourage men and women working in virtual teams to speak up so that the expertise held by the members can be better leveraged. This study represents an important step in this direction.

4.
Research and Practice in Thrombosis and Haemostasis ; 5(SUPPL 2), 2021.
Article in English | EMBASE | ID: covidwho-1509002

ABSTRACT

Background : Critically-ill COVID-19 patients demonstrate a hypercoagulable state, hence necessitating thromboprophylaxis. However, in non-critically ill COVID-19 patients, the haemostatic profile is unknown. Aims : A prospective, observational study was performed to evaluate coagulation parameters, and thrombotic outcomes in critically and non-critically ill COVID-19 patients. Methods : Informed consent was obtained from 10 critically ill (oxygen dependent, PaO2/FiO2 ratio<300) PCR positive COVID-19 patients matched for age and gender with 10 non-critically ill patients (nonoxygen dependent). On recruitment, laboratory (FBC/LDH/CRP/ procalcitonin) and coagulation tests (PT/APTT/D-Dimer/Fibrinogen/ TCT/Factors II,V,VII,VIII,IX,X,XI/vWF/anti-thrombinIII/ProteinC/ ProteinS/antiphospholipid antibodies), Thromboelastography(TEG), Clot Waveform Analysis(CWA) were performed, with repeat TEG/ CWA every 3 days, till 21 days of admission or discharge. This study was DSRB approved and supported by an NHG-NCID grant. Results : The median age was 60 years(49.5, 64.5) with 16 males and 4 females. Median Padua score of critically ill patients was 5 with PaO2/FiO2 ratio 194.5 (174, 241). Hypercoagulability was present in critically ill patients with elevated median levels of Fibrinogen 5.6 g/L(4.9, 6.6), D-dimer 1.0 μg/ml(0.6, 1.4), Factor VIII 206%(171, 230), von Willebrand Factor 265%(206, 321) as compared with lower levels in non-critically ill patients. Hypercoagulability was shown in TEG with increased CRT Angle 78.9°(78.3, 80.0), CFF MA 34.6 mm(27.4, 38.6) and CFF A10 30.9 s (25.5, 34.0);and CWA had increased clot velocity, aPTT Min1 7.7%/s(6.4, 8.3). CK K, CK Angle, CK MA, CRT MA were higher in critically ill patients (Table 1). In noncritically ill patients, D-dimer levels were normal, 0.3 μg/mL(0.3, 0.4) while Factor VIII levels of 176%(157, 192) and vWF levels of 225%(158, 237) were mildly elevated, with TEG and CWA demonstrating no hypercoagulability. 2 critically-ill patients developed thromboembolism(stroke, DVT) while no non-critically ill patients (not on thromboprophylaxis) had thrombosis. Conclusions : Critically ill COVID-19 patients demonstrate a hypercoagulable state with raised fibrinogen and Factor VIII levels correlating with raised CK, CRT, CFF maximal amplitude and increased CWA clot velocity(min1), while non-critical patients showed an absence of hypercoagulability in global tests of haemostasis.

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