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

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..

Medienart:	Klinische Studie

Erscheinungsjahr:	2022
Erschienen:	2022

Enthalten in:	ClinicalTrials.gov - (2022) vom: 26. Juli Zur Gesamtaufnahme - year:2022

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 COVID-19 Medical Condition: COVID-19 Pneumonia, Impaired Respiratory Function Phase: Phase 2 Pneumonia Recruitment Status: Completed Respiratory Insufficiency Study Type: Interventional

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: May 11, 2020, Last downloaded: ClinicalTrials.gov processed this data on August 01, 2022, Last updated: August 03, 2022

Study ID:	NCT04382053 CDFV890D12201 2020-001870-32
Veröffentlichungen zur Studie:

fisyears:
Förderinstitution / Projekttitel:

PPN (Katalog-ID):	CTG003386953