EUCTR2020-004448-27-DE
Active, not recruiting
Phase 1
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 - DZIF-10c_Inhalation
niversity of Cologne0 sites96 target enrollmentNovember 18, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- SARS-CoV-2 infection (only mild to moderate disease)
- Sponsor
- niversity of Cologne
- Enrollment
- 96
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •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
- •\-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
Outcomes
Primary Outcomes
Not specified
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