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Observational Study of COVID-19 Treatment Efficacy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369989
Recruitment Status : Enrolling by invitation
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
David Hall, OSF Healthcare System

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.

Condition or disease Intervention/treatment
Coronavirus Coronavirus Infection Corona Virus Infection COVID Sars-CoV2 Coronavirus as the Cause of Diseases Classified Elsewhere SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere COVID-19 Coronavirus Disease Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere Other: No intervention

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Observational Study of COVID-19 Treatment Efficacy
Actual Study Start Date : April 14, 2020
Estimated Primary Completion Date : April 14, 2021
Estimated Study Completion Date : April 14, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hydroxychloroquine - NO
Did not receive / are not receiving any Hydroxychloroquine
Other: No intervention
No intervention

Hydroxychloroquine - YES - started before
Hydroxychloroquine date started was before the date recorded for signs of respiratory distress
Other: No intervention
No intervention

Hydroxychloroquine - YES - started same
Hydroxychloroquine date started was the same as the date recorded for signs of respiratory distress
Other: No intervention
No intervention

Hydroxychloroquine - YES - started after
Hydroxychloroquine date started was after the date recorded for signs of respiratory distress
Other: No intervention
No intervention




Primary Outcome Measures :
  1. Mortality during the COVID-19 treatment hospital encounter [ Time Frame: up to 6 weeks ]
  2. ICU admission during the COVID-19 treatment hospital encounter [ Time Frame: up to 6 weeks ]
  3. Ventilator use during the COVID-19 treatment hospital encounter [ Time Frame: up to 6 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at all OSF HealthCare locations across the OSF Ministry that meet inclusion/exclusion criteria.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369989


Locations
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United States, Illinois
OSF HealthCare St Francis Medical Center
Peoria, Illinois, United States, 61637
Sponsors and Collaborators
OSF Healthcare System
Publications:
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Responsible Party: David Hall, Senior Vice President Information Systems / Chief Information Officer, Integrated Solutions, OSF Healthcare System
ClinicalTrials.gov Identifier: NCT04369989    
Other Study ID Numbers: 1589936
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases