NCT04373044

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

A Phase II Randomized Double-Blind Trial of Baricitinib or Placebo Combined With Antiviral Therapy in Patients With Moderate and Severe COVID-19

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine the efficacy of baricitinib combined with antiviral therapy in participants with COVID-19-related moderate and severe disease in terms of reduction of the proportion of participants requiring invasive mechanical ventilation or dying or requiring anti-IL6 monoclonal antibodies compared to that seen with antiviral alone within 60 days. SECONDARY OBJECTIVES: I. To describe the clinical findings in a cohort of symptomatic COVID-19-infected participants. II. To test whether cytokine signatures predict progression to invasive ventilatory support or death. III. To describe adverse events (AEs) associated with baricitinib when administered at 4mg in combination with antivirals. EXPLORATORY OBJECTIVES: I. Describe the decay in quantitative viral burden from saliva samples collected sequentially under treatment with baricitinib in combination with antivirals. II. To obtain preliminary data on efficacy and tolerability of baricitinib in combination with antivirals in participants with cancer. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive baricitinib orally (PO) daily, and standard of care hydroxychloroquine PO three times daily (TID). Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity. GROUP II: 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. Patients are followed for 60 days after enrollment to treatment.

Conditions

• Symptomatic COVID-19 Infection Laboratory-Confirmed

Interventions

Type	Name	Description
DRUG	Baricitinib	Given PO
DRUG	Hydroxychloroquine	Given PO
DRUG	Placebo Administration	Given Po

Timeline

• Start date: 2020-05-01
• Primary completion: 2021-05-12
• Completion: 2021-05-12
• First posted: 2020-05-04
• Last updated: 2021-05-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study