Observational Study of COVID-19 Treatment Efficacy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- OSF Healthcare System
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Ventilator use during the COVID-19 treatment hospital encounter
Study Overview
Brief Summary
To compare various treatments provided to positive COVID-19 patients at locations across the OSF Ministry. Provide the opportunity to compare the effectiveness of various treatments and treatment timelines provided to specific cohorts of patients that have the potential to impact future treatment plans for COVID-19 patients and/or future research hypotheses.
Detailed Description
Background:
Several studies have indicated a potential role for Hydroxychloroquine in the treatment of COVID-19 as caused by the SARS-CoV-2 virus. Hydroxychloroquine has demonstrated potent inhibition of SARS-CoV-2 in vitro. Hydroxychloroquine and azithromycin together have significantly reduced SARS-CoV-2 viral carriage over 6 days compared to a placebo and COVID-19 patients who received a 5 day regimen of 400mg/day of Hydroxychloroquine had significantly shortened times to clinical recovery characterized by improved pneumonia compared with patients who did not receive Hydroxychloroquine.
Within OSF Healthcare approximately 50% of SARS-CoV-2 infected patients are currently receiving some form of Hydroxychloroquine during the course of their hospitalization. The utilization of this treatment has been approved by the FDA based upon the limited data available.
Significance:
The optimal treatment regimen for COVID-19 patients has yet to be defined. Several small studies have indicated a potential role for the utilization of Hydroxychloroquine in the treatment of SARS-CoV-2 infected patients. However, very little evidence exists around the optimal treatment regimen and efficacy with regard to tangible outcomes. This observational retrospective/prospective chart review study aims to help provide epidemiological data that may help to provide guidance to clinicians for both future patients, as well as provide clinicians guidance for study design of more definitive controlled studies. Given the rapid spread of this disease, the high mortality rate associated with it and the impact of the disease upon society this study is anticipated to have the potential to contribute significantly to the treatment of SARS-CoV-2 infected patients.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •test positive for COVID-19
- •be inpatient
- •Have signs of respiratory distress = had either an SpO2 of less 95% or lower recorded or a respiratory rate RR >20 (21 or more) recorded and <60 (eliminate aberrant charting)
Exclusion Criteria
- •Age less than 18
- •Currently actively in an investigational drug trial
Outcomes
Primary Outcomes
Ventilator use during the COVID-19 treatment hospital encounter
Time Frame: up to 6 weeks
Mortality during the COVID-19 treatment hospital encounter
Time Frame: up to 6 weeks
ICU admission during the COVID-19 treatment hospital encounter
Time Frame: up to 6 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
David Hall
Senior Vice President Information Systems / Chief Information Officer, Integrated Solutions
OSF Healthcare System