Trial to test the safety, half-life, and antiviral efficacy of a new drug (human antibody) called DZIF-10c (administered intravenously) in healthy volunteers and SARS-CoV-2-infected participants
- Conditions
- SARS-CoV-2 infection (only mild to moderate disease)MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-003503-34-DE
- Lead Sponsor
- niversity of Cologne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 69
Groups 1A-1D
- Age 18 to 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 to 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 angeusia, 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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17
- 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.
- Blood laboratory parameter abnormalities as listed below
- 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 unwilligness to comply with the requirements for highly effective contraception.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and tolerability of a single intravenous infusion of DZIF-10c in SARS-CoV-2-uninfected and SARS-CoV-2-infected individuals.;Secondary Objective: Secondary Objectives<br>- To determine the pharmacokinetics of DZIF-10c after a single intravenous infusion.<br>- To determine the development of antibodies targeting DZIF-10c (anti-drug antibodies, ADA) following a single DZIF-10c infusion.<br>- To evaluate the effect of a single DZIF-10c infusion on viral shedding in nasopharyngeal swabs by qRT-PCR in SARS-CoV-2-infected individuals.<br>;Primary end point(s): The rate of adverse events that occur during study <br>;Timepoint(s) of evaluation of this end point: - The dose limiting toxicity (DLT) period comprises the first 7 days after treatment with DZIF-10c, adverse evnets until End of follow up period (90 day after treatment with DZIF-10c)
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: please see protocol;Secondary end point(s): - The pharmacokinetic profile of DZIF-10c, including elimination half-life, peak serum concentration, area under the curve, clearance, and volume of distribution.<br>- The frequency and magnitude of anti-drug antibodies targeting DZIF-10c following DZIF-10c infusion.<br>- SARS-CoV-2 RNA shedding in nasopharyngeal swabs determined by qRT-PCR in SARS-CoV-2-infected individuals.<br>