COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001936-86/DE

Hannover Medical School - Institute of Transfusion Medicine

Not reported

2020-08-20

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Patients infected with SARS-CoV-2 virus and 1. age ≥ 18 years and ≤ 75 years 2. fulfills RKI case definition including a positive verification of a SARS-CoV-2 infection from any specimen (e.g. respiratory, blood, other bodily fluid)* * confirmed by PCR (BAL, sputum, nasal and/or pharyngeal swap) 3. mild disease defined by the following criteria: - Hospitalized (score 3 or 4 of WHO R&D Blueprint ordinal scale for clinical improvement) 4. signed written informed consent and willingness to comply with treatment and follow-up procedures 5. ► men, or ► women without childbearing potential defined as follows: at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy, hysterectomy or uterine agenesis, ≥ 50 years and in postmenopausal state > 1 year, or < 50 years and in postmenopausal state > 1 year with serum FSH > 40 IU/l and serum estrogen < 30 ng/l or a negative estrogen test, both at screening, or ► women with childbearing potential: who are practicing true abstinence from sexual intercourse (periodic abstinence and withdrawal are not acceptable), who have sexual relationship with female partners only and/or with sterile male partners, or who are sexually active with fertile male partner, have a negative pregnancy test during screening and agree to use reliable methods of contraception from the time of screening until end of the clinical trial.

1. Accompanying diseases other than COVID-19 with an expected survival time of less than 12 months 2. In the opinion of the clinical team, progression to death is imminent and inevitable with-in the next 24 hours, irrespective of the provision of treatment 3. Chronic obstructive lung disease (COPD), stage 4 4. Lung fibrosis with UIP pattern in CT und severe emphysema 5. Chronic heart failure NYHA >= 3 and/or pre-existing reduction of left ventricular ejection fraction to ≤ 30% 6. Liver cirrhosis Child C 7. Liver failure: Bilirubin > 5xULN and elevation of ALT /AST (at least one >10xULN). 8. End stage renal failure requiring hemodialysis 9. Organ or bone marrow transplant in the three month prior to screening 10. History of adverse reactions to plasma proteins 11. Known deficiency of immunoglobulin A 12. Pregnancy and breastfeeding women 13. Volume overload until sufficiently treated 14. Pulmonary edema 15. Body mass index (BMI) > 40 kg/m2 16. Participation in another clinical trial, especially for treatment of COVID-19 17. Allergy or other contraindication to one of the investigational products 18. Previous treatment with SARS-CoV-2 convalescent plasma

2

Hannover Medical School

18

75

Germany

Moderate disease at enrollment

3: Moderate disease at enrollment

340

Proportion of patients with treatment failure on day 14. A treatment failure is defined as pro-gression of COVID-19 disease. Progression is defined as score 5, 6, 7 or 8 of WHO R&D Blueprint ordinal scale for clinical improvement.

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]