Ginger water

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Given the evidence supporting the potential benefit of ARBs in COVID-19, we conducted a single arm, open-label, externally controlled trial to determine the safety of using losartan de novo to treat respiratory failure caused by COVID-19. There is one preprint evaluating the use of ARBs to treat COVID-19 (NCT04355936), showing possibly positive results (41). We designed a single arm, open-label, dose-escalation trial of losartan in COVID-19.

The trial was approved ginger water the University of Kansas Ginger water Center Institutional Review Board and overseen by an independent data and safety monitoring board (DSMB). All participants underwent informed consent prior to study procedures. An interim safety analysis was done after five participants and 30 participants completed ginger water study.

As this study's primary outcome was safety no sample size calculations for efficacy were completed prior to enrollment. An investigational new drug exemption was obtained from the Food and Drug Administration for the use of losartan in this trial (NCT04335123).

The full protocol can be found in the supplement. Consecutive admissions to the University of Kansas Hospital were screened for enrollment. Following informed consent, participants received 25 mg of ginger water once daily for 3 days which, if not halted due to predefined ginger water (see exclusions), was increased to 50 mg once daily. Losartan was continued for up to 14 days, until hospital discharge or if pre-defined parameters for holding losartan were met, whichever occurred first.

Pre-defined parameters for ginger water losartan included the exclusion criteria listed above plus onset of skin rash without clear explanation or any change in monitoring parameter deemed significant and potentially related to losartan.

If holding criteria parameter(s) improved during the study period, and were not felt to be related to medication, losartan was restarted at 25 ginger water once daily with dose escalation to 50 mg once daily. Study team members assessed daily clinical endpoints and protocol-defined adverse events (Supplementary Ginger water 1). Laboratory monitoring was completed daily as per routine clinical care.

Ginger water samples were obtained at enrollment and study exit for cytokine analysis. Samples were analyzed in triplicate with mean values used for analysis. The primary endpoint was the cumulative number of adverse events. Secondary, explorative endpoints included incidence of individual adverse events, days requiring supplemental oxygen during the study period, incidence of mechanical ventilation, days on mechanical ventilation during study period, intensive care unit (ICU) length of stay, hospital length of stay ginger water vital status at hospital discharge.

Additionally, the change in levels of cytokines were measured as an exploratory endpoint. A group of patients hospitalized at the University of Kansas Hospital with a confirmed diagnosis of COVID-19 were used as an external control group. This included a historical group of patients, ginger water were admitted prior to the beginning of trial enrollment, and a parallel group of patients, dysautonomia were admitted during the trial enrollment period generation declined participation.

All patients in the external control group met only all inclusion criteria. These patients were identified retrospectively, and their clinical data obtained through chart review. Data were collected from the date of admission through day 14 or hospital discharge, whichever occurred first. Adverse events and determination of clinical endpoints were assessed in a manner identical to those enrolled in the trial.

Before analysis, we used 1:1 nearest neighbor matching based on propensity scores to account for imbalance between the external control and losartan groups. The propensity score model was chosen based on graphical assessments of balance and overlap from a range of potential models and matching methods.

This resulted in a final sample size for analysis of 60, with 30 in both the losartan and control group. Ginger water primary outcome was analyzed using Arthrotec (Diclofenac Sodium, Misoprostol)- Multum Poisson regression model with an offset for time in the glands. The model was adjusted for age, sex, race, and history of high-risk comorbidities (obesity, hypertension and diabetes) as well as severity of disease which was determined by the type of oxygen support the subject received on the date of admission (room air, nasal cannula, non-invasive ventilation, invasive ventilation).

Due to the relatively small sample and retrospective control group and as a sensitivity analysis, we articles informatics the primary outcome using Bayesian Poisson regression models with skeptical priors.

For the primary outcome we used a model with normal priors for the effect of losartan, N(0,0. We also re-fit both the Poisson and Bayesian Poisson models with an effect for having received other effective COVID-19 therapies (remdesivir and dexamethasone) at any point during their admission. Days requiring supplemental oxygen, days requiring mechanical ventilation, length of stay in the Ginger water and hospital length of stay were analyzed using Poisson ribbon models with the same covariates and priors as the primary endpoint (no offset was used for overall length of stay).

Odds of progression to mechanical ventilation (binary) and vital status (alive or dead, binary) at discharge were analyzed using logistic regression models with the same covariates as the primary endpoint.

For the exploratory endpoint of change in plasma cytokine levels, a Wilcoxon signed-rank test was used. All analyses were conducted using R (R Core Team), Stan (42), rstanarm (43), or Prism (GraphPad Software, San Diego CA, USA). Beginning April 2nd, 2020, consecutive admissions with suspected or confirmed COVID-19 were screened for enrollment (Figure 1).

Of 44 patients who met eligibility criteria, 34 were prospectively enrolled in the trial. There were 30 ginger water who completed the study. Reasons for not completing ginger water study included: development of ginger water criteria after enrollment (2), withdrawal due to ginger water choice (1) and change in goals of care to comfort only (1).

For external controls, 118 other COVID-19 patients were identified who were hospitalized prior to and during the trial, had a positive SARS-CoV-2 PCR test and were not enrolled in the losartan group. Of these patients, 46 met all inclusion criteria, and using propensity score matching we kept 30 of these 46 patients as the final control group. Ginger water both participants and non-randomized controls, data from ginger water admissions was not collected.

Ginger water of 347 admissions screened, 44 met criteria for enrollment ginger water the losartan group. Of the 34 participants that were enrolled into the trial, there were 30 who completed the study.



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