At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 57 enrolled
Drug / intervention
DZIF-10c +1 morebiological
Likely dose
Not stated in 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.
A Phase 1/2a Trial of the Intravenous Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c in SARS-CoV-2-Infected and -Uninfected Individuals
In Brief
A Phase 2 clinical trial evaluating DZIF-10c and Placebo for SARS-CoV-2 Infection. Completed, enrolled 57 participants across 1 site.
Detailed Summary
This is the first-in-human phase 1/2a trial of the intravenous administration of the SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c in healthy volunteers and SARS-CoV-2-infected individuals. It will evaluate the safety, pharmacokinetic profile, immunogenicity, and antiviral activity of DZIF-10c.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSARS-CoV-2 Infection
CountriesGermany
CollaboratorsZKS Köln, Boehringer Ingelheim
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedNov 2020
Enrollment StartDec 2020
Primary CompletionAug 2021
TodayJul 2026
First PostedNov 17, 2020
Enrollment StartDec 8, 2020
Primary CompletionAug 11, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.6 years ago
Interventions
DZIF-10cbiological
SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion
Placeboother
Intravenous infusion of sterile normal saline (NaCl 0.9%) as placebo