SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Infusion
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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: NCT04631666 |
Recruitment Status :
Completed
First Posted : November 17, 2020
Last Update Posted : August 24, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
SARS-CoV-2 Infection | Biological: DZIF-10c Other: Placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 57 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | This study consists of an open-label dose escalation phase in healthy volunteers (Groups 1A-1C) and an additional open-label lead-in phase in SARS-CoV-2-infected individuals (Group 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). An additional higher dose cohort may be included for healthy volunteers (Group 1D). |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | December 8, 2020 |
Actual Primary Completion Date : | August 11, 2021 |
Actual Study Completion Date : | August 11, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Group 1A (uninfected) - 2.5 mg/kg
SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 2.5 mg/kg
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Biological: DZIF-10c
SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion |
Experimental: Group 1B (uninfected) - 10 mg/kg
SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 10 mg/kg
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Biological: DZIF-10c
SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion |
Experimental: Group 1C (uninfected) - 40 mg/kg
SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 40 mg/kg
|
Biological: DZIF-10c
SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion |
Experimental: Group 1D (uninfected) - high dose
SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose higher than 40 mg/kg
|
Biological: DZIF-10c
SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion |
Experimental: Group 2C (infected) - 40 mg/kg
SARS-CoV-2-infected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 40 mg/kg
|
Biological: DZIF-10c
SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion |
Experimental: Group 2D (infected) - 40 mg/kg
SARS-CoV-2-infected volunteers will be randomized 2:1 to receive an intravenous infusion of DZIF-10c at a dose of 40 mg/kg or placebo
|
Biological: DZIF-10c
SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion Other: Placebo Intravenous infusion of sterile normal saline (NaCl 0.9%) as placebo |
- Rate of Adverse Events after a single DZIF-10c infusion [Safety and Tolerability] [ Time Frame: 3 months ]Primary target variables are (S)AEs and Adverse Events of Special Interest (AESIs)
- Pharmacokinetic profile of DZIF-10c [ Time Frame: 3 months ]Elimination half-life (t1/2) of DZIF-10c
- Pharmacokinetic profile of DZIF-10c [ Time Frame: 3 months ]Peak serum concentration (Cmax) of DZIF-10c
- Pharmacokinetic profile of DZIF-10c [ Time Frame: 3 months ]Area under the curve (AUC)
- Pharmacokinetic profile of DZIF-10c [ Time Frame: 3 months ]Clearance (CL/F) of DZIF-10c
- Pharmacokinetic profile of DZIF-10c [ Time Frame: 3 months ]Volume of distribution (Vz/F) of DZIF-10c
- Development of anti-drug antibodies [ Time Frame: 3 months ]Frequency of the development of anti-drug antibodies targeting DZIF-10c
- Development of anti-drug antibodies [ Time Frame: 3 months ]Magnitude of the development of anti-drug antibodies targeting DZIF-10c
- 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-1D
- 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 2C-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): NCT04631666
Germany | |
University Hospital Cologne | |
Cologne, NRW, Germany, 50937 |
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: | NCT04631666 |
Other Study ID Numbers: |
Uni-Koeln-4288 |
First Posted: | November 17, 2020 Key Record Dates |
Last Update Posted: | August 24, 2021 |
Last Verified: | August 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 Infusion Monoclonal Antibody |
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 |