Baricitinib, Placebo and Antiviral Therapy for the Treatment of Patients With Moderate and Severe COVID-19

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT04373044
Phase
PHASE2
Status
Terminated

Conditions

  • Symptomatic COVID-19 Infection Laboratory-Confirmed

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    Given PO
  • Hydroxychloroquine — DRUG
    Given PO
  • Placebo Administration — DRUG
    Given Po

Study Details

This phase II trial studies the effect of baricitinib in combination with antiviral therapy for the treatment of patients with moderate or severe coronavirus disease-2019 (COVID-19). Treatment with antiviral medications such as hydroxychloroquine, lopinavir/ritonavir, and/or remdesivir may act against infection caused by the virus responsible for COVID-19. Baricitinib may reduce lung inflammation. Giving baricitinib in combination with antiviral therapy may reduce the risk of the disease from getting worse and may help prevent the need for being placed on a ventilator should the disease worsen compared to antiviral therapy alone.

Key Dates

Start date
May 1, 2020
Status verified
May 2021
Primary completion
May 12, 2021
Completion
May 12, 2021

Study Design

Enrollment
6 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Arm II (placebo, antiviral therapy)
    Patients receive placebo PO daily, and standard of care hydroxychloroquine PO TID. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Treatment (baricitinib, antiviral therapy)
    Patients receive baricitinib PO daily, and standard of care hydroxychloroquine PO TID. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Proportion of patients requiring invasive mechanical ventilation or dying [ Time Frame: Up to 14 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Los Angeles County-USC Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-

Find similar trials in Los Angeles, CA

By research site
Los Angeles County-USC Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CA

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