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Clinical Trials/EUCTR2020-003503-34-DE
EUCTR2020-003503-34-DE
Active, not recruiting
Phase 1

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 - DZIF-10c_Infusion

niversity of Cologne0 sites69 target enrollmentNovember 10, 2020
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ConditionsSARS-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]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
SARS-CoV-2 infection (only mild to moderate disease)
Sponsor
niversity of Cologne
Enrollment
69
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 10, 2020
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity of Cologne

Eligibility Criteria

Inclusion Criteria

  • •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
  • •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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