Study of Efficacy and Safety of DV890 in Patients With COVID-19 Pneumonia
Condition: COVID-19 Pneumonia, Impaired Respiratory Function
MeSH terms: COVID-19; Pneumonia; Respiratory Insufficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical study was designed to assess the efficacy and safety of DFV890 for the
      treatment of severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) infected patients
      with coronavirus disease 2019 (COVID-19) pneumonia and impaired respiratory function.
    

Detailed description: 
      This was a Phase II, randomized, controlled, open label multi-center study to assess the
      efficacy and safety of DFV890 for the treatment of SARS-CoV-2 infected patients with COVID-19
      pneumonia and impaired respiratory function.

      The study consisted of four distinct study periods:

      Screening / Baseline visit (Day -1 to 1): lasted up to a maximum of 24 hours and comprised a
      screening / baseline assessment. This visit was used to confirm that the study inclusion and
      exclusion criteria were met and served as baseline assessment prior to randomization.

      Treatment period (Day 1-15): Participants were randomized as soon as possible, but within a
      maximum of 24 hours after screening in a 1:1 ratio receiving either DFV890 in addition to
      standard of care (SoC) or SoC alone. Participants in the investigational treatment arm
      received DFV890 administered for a total of 14 days in addition to SoC. Participants in the
      control arm received SoC alone. Study assessments were conducted every 2 days for
      hospitalized participants.

      The End of Treatment (EOT) visit took place on Day 15. If participants were discharged from
      the hospital prior to Day 15, assessments on the day of discharge were performed according to
      the schedule listed under Day 15; participants continued to take the investigational
      treatment at home to complete the 14-day treatment period and the participants returned to
      the site for the Day 15/EOT assessment. If a hospital visit was not possible at Day 15, then
      home nursing services were used to support the last visit.

      Follow-up (Day 16-29): After completion of the treatment period, participants were observed
      until Day 29 or discharged from hospital, whichever was sooner. Study assessments were
      conducted every 2 days for hospitalized participants. If participants were discharged from
      hospital prior to Day 29, a study visit conducted by telephone was performed on Day 29.

      30-day safety follow-up assessment (Day 45): A follow-up visit for safety was conducted by
      telephone.
    

Intervention name(s): DFV890; Standard of Care (SoC)
Intervention type(s): Drug; Drug
Intervention description(s): DFV890 25 mg tablets orally/nasogastrically administered 50 mg b.i.d for 14 days in addition to SoC.; SoC included a variety of supportive therapies that ranged from the administration of supplementary oxygen to full intensive care support, alongside the use of antiviral treatment, convalescent plasma, corticosteroids, antibiotics or other agents.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19 pneumonia; SARS-CoV-2; APACHE II; DFV890; inflammasome