NCT04369989

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2021

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

April 28, 2020

Last Update Submit

September 27, 2022

Conditions

CoronavirusCoronavirus InfectionCorona Virus InfectionCOVIDSars-CoV2Coronavirus as the Cause of Diseases Classified ElsewhereSARS-Associated Coronavirus as Cause of Disease Classified ElsewhereCOVID-19Coronavirus DiseaseCoronavirus Sars-Associated as Cause of Disease Classified Elsewhere

Outcome Measures

Primary Outcomes (3)

  • Mortality during the COVID-19 treatment hospital encounter

    up to 6 weeks

  • ICU admission during the COVID-19 treatment hospital encounter

    up to 6 weeks

  • Ventilator use during the COVID-19 treatment hospital encounter

    up to 6 weeks

Study Arms (4)

Hydroxychloroquine - NO

Did not receive / are not receiving any Hydroxychloroquine

Other: No intervention

Hydroxychloroquine - YES - started before

Hydroxychloroquine date started was before the date recorded for signs of respiratory distress

Other: No intervention

Hydroxychloroquine - YES - started same

Hydroxychloroquine date started was the same as the date recorded for signs of respiratory distress

Other: No intervention

Hydroxychloroquine - YES - started after

Hydroxychloroquine date started was after the date recorded for signs of respiratory distress

Other: No intervention

Interventions

No interventionOTHER

No intervention

Hydroxychloroquine - NOHydroxychloroquine - YES - started afterHydroxychloroquine - YES - started beforeHydroxychloroquine - YES - started same

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients at all OSF HealthCare locations across the OSF Ministry that meet inclusion/exclusion criteria.

You may qualify if:

  • 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)

You may not qualify if:

  • Age less than 18
  • Currently actively in an investigational drug trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OSF HealthCare St Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Related Publications (3)

  • Yao X, Ye F, Zhang M, Cui C, Huang B, Niu P, Liu X, Zhao L, Dong E, Song C, Zhan S, Lu R, Li H, Tan W, Liu D. In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2020 Jul 28;71(15):732-739. doi: 10.1093/cid/ciaa237.

    PMID: 32150618BACKGROUND

  • Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. RETRACTED: Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.

    PMID: 32205204BACKGROUND

  • Efficacy of hydroxychloroquine in patients with COVID-19: results of a randomized clinical trial Zhaowei Chen, Jijia Hu, Zongwei Zhang, Shan Jiang, Shoumeng Han, Dandan Yan, Ruhong Zhuang, Ben Hu and Zhan Zhang; medRxiv preprint doi: https://doi.org/10.1101/2020.03.22.20040758. 03.31.2020

    BACKGROUND

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Vice President Information Systems / Chief Information Officer, Integrated Solutions

Study Record Dates

First Submitted

April 28, 2020

First Posted

April 30, 2020

Study Start

April 14, 2020

Primary Completion

April 14, 2021

Study Completion

April 14, 2021

Last Updated

September 29, 2022

Record last verified: 2022-09

Locations

US(1)