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

• Status: Completed
• Trial end date: 2021-09-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Cologne
• Collaborators: Boehringer Ingelheim; ZKS Köln

Criteria

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