CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 143 enrolled
Drug / intervention
DFV890 +1 moredrug
Likely dose
DFV890 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04382053
NCT04382053Phase 2Completed
CompareCT.gov

Phase 2, Randomized, Controlled, Open Label Multi-center Study to Assess Efficacy and Safety of DFV890 for the Treatment of SARS-CoV-2 Infected Patients With COVID-19 Pneumonia and Impaired Respiratory Function

Novartis Pharmaceuticals·interventional·Posted May 11, 2020·Updated Jul 26, 2022

In Brief

A Phase 2 clinical trial evaluating DFV890 and Standard of Care (SoC) for COVID-19 Pneumonia, Impaired Respiratory Function. Completed, enrolled 143 participants across 29 sites in 12 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19 Pneumonia, Impaired Respiratory Function
CountriesArgentina, Brazil, Denmark, Germany, Hungary, India, Mexico, Netherlands, Peru, Russia, South Africa, Spain
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMay 11, 2020
Enrollment StartMay 27, 2020
Primary CompletionDec 10, 2020
Study CompletionDec 24, 2020
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.1 years ago

Interventions

DFV890drug

DFV890 25 mg tablets orally/nasogastrically administered 50 mg b.i.d for 14 days in addition to SoC.

Standard of Care (SoC)drug

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.