Status:
TERMINATED
Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease
Lead Sponsor:
LCMC Health
Conditions:
COVID-19
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
This study proposes to evaluate clinical outcomes and viral load in COVID-19 infected patients with early moderate and severe disease admitted to the hospital and randomized to one of three arms. Pati...
Detailed Description
This is a phase 3 study. Primary Objective: • To evaluate clinical outcomes in patients with suspected or confirmed COVID-19 with early moderate to severe disease in a randomized controlled trial. ...
Eligibility Criteria
Inclusion
- Age greater than 18 years
- Positive SARS-CoV-2 testing or consistent clinical syndrome (based on clinical picture e.g. characteristic infiltrates on chest x-ray, laboratory findings, and with agreement by two physicians) in patients under investigation (PUIs).
- Onset of symptoms \< 7 days from date of enrollment
- Oxygen saturation of \>94% on room air with defined risk factors (Table 1) consistent with moderate disease OR oxygen saturation of \< 94% on room air consistent with severe disease
- Ability and willingness to comply with study procedures
Exclusion
- QTc greater than 450 milliseconds on screening EKG
- Pregnant or lactating women
- Inability to take oral pills or inability to use a feeding tube
- Inability to obtain informed consent either from the patient or from the next of kin if patient is incapacitated. For the purpose of this study obtaining a verbal consent from a family member on the phone with a witness will be considered acceptable since there is a 'no visitor' policy in force at hospitals.
- Patients requiring ICU level care
- use of azithromycin or hydroxychloroquine within 30 days prior to admission
Key Trial Info
Start Date :
April 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04344444
Start Date
April 13 2020
End Date
January 5 2022
Last Update
January 21 2022
Active Locations (1)
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1
University Medical Center New Orleans
New Orleans, Louisiana, United States, 70112