COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04631666

Gerd Faetkenheuer, Univ.-Prof.

Florian Klein, florian.klein@uk-koeln.de (PI email not reported)

2020-11-17

Completed

RCT

Randomized

Sequential assignment

Blind label

single-center

Treatment

inclusion criteria: groups 1a-1d - 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 2c-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

None

6

University of Cologne

18

70

Germany

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

57

Proportion of Patients With Any AE Within 7 d of Study Drug Infusion

None

Phase 1/Phase 2

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