Study of Efficacy and Safety of DV890 in Patients With COVID-19 Pneumonia

NCT04382053 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2022-07-26

Study results available
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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.

Conditions

  • COVID-19 Pneumonia, Impaired Respiratory Function

Interventions

DRUG

DFV890

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

DRUG

Standard of Care (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.

Sponsors & Collaborators

Principal Investigators

  • Novartis pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-27
Primary Completion
2020-12-10
Completion
2020-12-24
FDA Drug
Yes

Countries

  • Argentina
  • Brazil
  • Denmark
  • Germany
  • Hungary
  • India
  • Mexico
  • Netherlands
  • Peru
  • Russia
  • South Africa
  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04382053 on ClinicalTrials.gov