SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Inhalation
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04631705 |
Recruitment Status :
Completed
First Posted : November 17, 2020
Last Update Posted : October 26, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
SARS-CoV-2 Infection | Biological: DZIF-10c Drug: Placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | This study consists of an open-label dose escalation phase in both healthy volunteers (Groups 1A-1C) and SARS-CoV-2-infected participants (Groups 2A-2C). After completion of the dose escalation phase, SARS-CoV-2-infected individuals will be enrolled into a randomized placebo-controlled expansion cohort (Group 2D). |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | December 14, 2020 |
Actual Primary Completion Date : | September 23, 2021 |
Actual Study Completion Date : | September 23, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Group 1A (uninfected) - low dose
SARS-CoV-2-uninfected volunteers will receive a single dose of DZIF-10c by inhalation
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Biological: DZIF-10c
Inhaled administration of the human monoclonal antibody DZIF-10c |
Experimental: Group 1B (uninfected) - mid dose
SARS-CoV-2-uninfected volunteers will receive a single dose of DZIF-10c by inhalation
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Biological: DZIF-10c
Inhaled administration of the human monoclonal antibody DZIF-10c |
Experimental: Group 1C (uninfected) - high dose
SARS-CoV-2-uninfected volunteers will receive a single dose of DZIF-10c by inhalation
|
Biological: DZIF-10c
Inhaled administration of the human monoclonal antibody DZIF-10c |
Experimental: Group 2A (infected) - low dose
SARS-CoV-2-infected volunteers will receive a single dose of DZIF-10c by inhalation
|
Biological: DZIF-10c
Inhaled administration of the human monoclonal antibody DZIF-10c |
Experimental: Group 2B (infected) - mid dose
SARS-CoV-2-infected volunteers will receive a single dose of DZIF-10c by inhalation
|
Biological: DZIF-10c
Inhaled administration of the human monoclonal antibody DZIF-10c |
Experimental: Group 2C (infected) - high dose
SARS-CoV-2-infected volunteers will receive a single dose of DZIF-10c by inhalation
|
Biological: DZIF-10c
Inhaled administration of the human monoclonal antibody DZIF-10c |
Experimental: Group 2D (infected)
SARS-CoV-2-infected volunteers will be randomized 1:1:1 to receive DZIF-10c by inhalation and infusion, DZIF-10c by inhalation and placebo by infusion, or placebo by inhalation and infusion
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Biological: DZIF-10c
Inhaled administration of the human monoclonal antibody DZIF-10c Biological: DZIF-10c Intravenous administration of the human monoclonal antibody DZIF-10c Drug: Placebo Inhalation of DZIF-10c diluent as placebo Drug: Placebo Intravenous infusion of sterile normal saline (NaCl 0.9%) as placebo |
- Rate of Adverse Events after a single DZIF-10c inhalation [Safety and Tolerability] [ Time Frame: 3 months ]Primary target variables are (S)AEs and Adverse Events of Special Interest (AESIs)
- Rate of Adverse Events after a single combined DZIF-10c inhalation and infusion [Safety and Tolerability] [ Time Frame: 3 months ]Primary target variables are (S)AEs and Adverse Events of Special Interest (AESIs)
- Pharmacokinetic parameter AUC0-672 [ Time Frame: 0 to 672 hours ]AUC0-672 (the area under the concentration-time curve of DZIF-10c in serum over the time interval from 0 to 672 hours (Day 28)) after inhaled and combined inhaled and intravenous application
- Development of anti-drug antibodies [ Time Frame: 3 months ]Frequency of the development of anti-drug antibodies targeting DZIF-10c determined by immunoassay
- Development of anti-drug antibodies [ Time Frame: 3 months ]Titer of anti-drug antibodies targeting DZIF-10c determined by immunoassay
- Change in viral load in nasopharyngeal swabs after DZIF-10c administration [ Time Frame: 28 days ]Change in SARS-CoV-2 RNA from baseline in nasopharyngeal swabs as determined by qRT-pCR

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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 (all groups):
- 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
- eGFR <60 ml/min/1.73m2
- Pregnancy or lactation.
- Any vaccination within 14 days prior to DZIF-10c administration.
- Receipt of any SARS-CoV-2 vaccine or SARS-CoV-2 monoclonal antibody in the past.
- Diagnosis of bronchial asthma or history of bronchial hyperresponsiveness, COPD, pulmonary fibrosis, or other chronic lung diseases.
- Any chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer.
- History of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months (a single administration of systemic corticosteroids within ≤6 months and ≥4 weeks of enrollment is acceptable).
- Participation in another clinical trial of an investigational medicinal product within the past 12 weeks or expected participation during this study.
- Dependency on the principal investigator or study staff; or site personnel directly affiliated with this trial.
- Legally incapacitated individuals
- Individuals held in an institution by legal or official order
- If engaging in sexual activity that could result in pregnancy, inability or unwillingness to comply with the requirements for highly effective contraception

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04631705
Germany | |
University Hospital Gießen and Marburg | |
Gießen, Hesse, Germany, 35392 | |
University Hospital Cologne | |
Cologne, NRW, Germany, 50937 | |
University Hospital Düsseldorf | |
Düsseldorf, Germany, 40225 | |
University Hospital Frankfurt | |
Frankfurt am Main, Germany, 60590 | |
University Medical Center Hamburg-Eppendorf | |
Hamburg, Germany, 20246 | |
LMU Munich University Hospital | |
Munich, Germany, 81377 |
Principal Investigator: | Gerd Fätkenheuer, MD | University of Cologne |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Florian Klein, Investigator, University of Cologne |
ClinicalTrials.gov Identifier: | NCT04631705 |
Other Study ID Numbers: |
Uni-Koeln-4370 |
First Posted: | November 17, 2020 Key Record Dates |
Last Update Posted: | October 26, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
SARS-CoV-2 Covid-19 Monoclonal Antibody Inhalation |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |