- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04962347
Real World Study of COVID-19 in a Flyover Region
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
This study involves extracting data from 10,000 patients with Polymerase Chain Reaction (qPCR) confirmed COVID-19 infection through electronic-charts of Tulane Medical Center and University Medical Center (New Orleans, Louisiana) and Doctors Hospital at Renaissance (DHR) system (Texas). According to the inclusion criteria below and spanning from September 2019 - December 2021 we predict to include 1500 RDV treated patients and 8500 non-treated comparators, all with COVID-19, through the Research Action for Health Network (REACHnet) (link: https://eco.reachnet.org) in partnership with the Louisiana Public Health Institute (LPHI).
Statistical plan:
Following anonymized data extraction, propensity score will be used to compare primary and secondary endpoints between matched COVID-19 infected patients who received RDV to those who did not receive RDV. Patients of both cohorts will be stratified by severity. Moderate and severe respiratory distress associated with COVID-19 are defined as per US-GS-540-5773 and US-GS-540-5774 clinical trials. Through the investigator's extensive Electronic Medical Record (EMR) data collection network including diverse underserved populations of the U.S. Gulf South, they will evaluate real world outcomes of RDV treatment for COVID-19. The 2 cohorts will be compared with focus upon respiratory distress evolution, co-morbidities and other illness associated/relevant to COVID-19 course during admission, post-discharge during convalescent period of up to 6 months, and documentation of pre-admission comorbidities in the 6 months pre-admit.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Louisiana
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New Orleans, Louisiana, Förenta staterna, 70112
- Tulane University Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Positive qRT PCR for COVID-19 from a nasopharyngeal, nasal, or oropharyngeal swab or from bronchoalveolar lavage.
- Received RDV (cases) or did not receive RDV (controls).
- Age ≥ 18 years
Exclusion Criteria:
- None.
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
The change of clinical severity, as measured using 7-point ordinal clinical severity scale, from first RDV dose through day 11 post-dose.
Tidsram: Change from Day 1 to Day 11
|
Clinical severity will be measured using 7-point ordinal scale (1 Death, 2 Hospitalized, on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO), 3 Hospitalized, on non-invasive ventilation or high flow oxygen devices, 4 Hospitalized, requiring low flow supplemental oxygen (less than 15L), 5 Hospitalized, not requiring supplemental oxygen-requiring ongoing medical care (COVID-19 related or otherwise), 6 Hospitalized, not requiring oxygen-no longer requires ongoing medical care, 7 Not hospitalized.
The improvement and change in clinical severity, from first RDV dose recorded as Day 1 to Day 11 is recorded.
|
Change from Day 1 to Day 11
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Mortality during admission
Tidsram: 6 months
|
Mortality rate change during admission compared between RDV vs non-RDV subjects
|
6 months
|
Mortality at 6 months following symptom onset
Tidsram: 6 months
|
Mortality rate through end of study period (6 months following symptom onset) compared between RDV vs non-RDV subjects
|
6 months
|
Post-COVID-19 symptoms
Tidsram: 6 months
|
Impact measurement of acute COVID-19 RDV on post-COVID-19 symptoms/morbidity compared between RDV vs non-RDV subjects
|
6 months
|
Post-COVID-19 mortality
Tidsram: 6 months
|
Impact measurement of acute COVID-19 RDV on post-COVID-19 mortality compared between RDV vs non-RDV subjects
|
6 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Arnaud Drouin, MD, PhD, Tulane University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2021-112
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