Trial to test the safety, half-life, and antiviral efficacy of a new drug (human antibody) called DZIF-10c (administered inhalatively) in healthy volunteers and SARS-CoV-2-infected participants

Phase 1

• Conditions: SARS-CoV-2 infection (only mild to moderate disease); MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-004448-27-DE
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-18
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Groups 1A-1C
-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 72
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

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.
-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