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SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Inhalation | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Inhalation

A Phase 1/2a Trial of the Inhaled Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c in SARS-CoV-2-Infected and -Uninfected Individuals

NCT04631705•University of Cologne

View on ClinicalTrials.gov

Summary

This is the first-in-human phase 1/2a trial of the inhaled 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.

Detailed Description

The phase 1 component of this trial consists of a single-inhalation open-label dose-escalation phase (Groups 1A-1C and Groups 2A-2C). Subsequently, the highest tolerated dose tested will be administered to an expansion cohort of SARS-CoV-2-infected individuals (Group 2D). In this randomized and blinded group, participants will receive DZIF-10c or placebo both by inhalation and intravenous infusion.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Groups 1A-1C
•Age 18-65.
•SARS-CoV-2-RNA negative naso- or oropharyngeal swab obtained within 3 calendar days before study drug administration by NAAT (e.g., qRT-PCR).
•Non-reactivity of serum antibodies (IgG; and IgA and/or IgM when tested) against SARS-CoV-2 by serological assay at screening.
•Groups 2A-2D
•Age 18-70.
•SARS-CoV-2-RNA positive naso- or oropharyngeal swab obtained within 3 calendar days before study drug administration by NAAT (e.g., qRT-PCR).
•Onset of COVID-19 symptoms (e.g., sore throat, cough, fever, chills, fatigue, dys- or anosmia, dys- or ageusia, headache, muscle pain, gastrointestinal symptoms) within 7 days prior to study drug administration or Non-reactivity of serum or plasma antibodies (IgG; and IgA and/or IgM when tested) against SARS-CoV-2 by serological assay at screening.
•Disease severity score 1-4 as defined by the WHO Clinical Progression Scale (WHO, Lancet Inf Dis 2020)

Exclusion Criteria

•Known hypersensitivity to any constituent of the investigational medicinal product.
•Hepatitis B infection indicated by detectable HBsAg (Hepatitis B surface antigen) in blood.
•Detectable antibodies against hepatitis C virus in blood unless active hepatitis C is ruled out by negative HCV-RNA.
•HIV infection indicated by detectable HIV antigen and/or HIV antibodies in blood.
•Neutrophil count ≤1,000 cells/µl
•Hemoglobin ≤10 g/dl
•Platelet count ≤100,000 cells/µl
•ALT ≥2.0 x ULN
•AST ≥2.0 x ULN
•Total bilirubin ≥1.5 ULN
+12 more criteria

Locations (6)

University Hospital Gießen and Marburg

Giessen, Hesse, Germany

University Hospital Cologne

Cologne, North Rhine-Westphalia, Germany

University Hospital Düsseldorf

Düsseldorf, Germany

University Hospital Frankfurt

Frankfurt am Main, Germany

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

LMU Munich University Hospital

Munich, Germany

Key Dates

Start Date

December 14, 2020

Primary Completion Date

September 23, 2021

Completion Date

September 23, 2021

Last Updated

October 3, 2024

Enrollment

ACTUAL participants

Conditions

SARS-CoV-2 Infection

Interventions

DZIF-10c

BIOLOGICAL

DZIF-10c

BIOLOGICAL

Placebo

DRUG

Placebo

DRUG

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NCT06631287

Long COVIDSars-CoV-2 Infection+2 more

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RECRUITINGPHASE1

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NCT05141058

SARS-CoV-2 Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Inhalation

Inclusion Criteria

Exclusion Criteria

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients

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Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)

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