COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001550-22/DE

University of Ulm - Markus Huber-Lang

markus.huber-lang@uniklinik-ulm.de

2020-08-31

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

1.Hospitalized adult (age ≥ 18), of any gender, with confirmed SARSCoV-2 infection with an oxygen saturation (SaO2) of 94% or less while they were breathing ambient air, or a ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) of less than 300 mm Hg. 2.Diagnosed with SARS-CoV-2 infection, according to the following criteria: −Demonstration of SARS-CoV-2 RNAemia in nasopharyngeal swap or bronchio-alveolar lavage (BAL) (the test that will be used for SARSCoV-2 RNAemia is certified with the CE mark and will be used within the scope of its intended purpose) −Pneumonia confirmed by chest imaging (ultrasound, X-ray, CT, etc.) 3.Dated and signed informed consent from patient.

1.Demonstrated or suspected uncontrolled systemic severe infection, such as sepsis (e.g.: positive blood culture, or procalcitonin ≥0.25 μg/L) 2.Demonstrated local extrapulmonary abscess 3.Chemotherapy for less than 3 months 4.Use of other investigational drug within 4 weeks or a period of 5 half-lives duration prior to Day1 (whichever is longer) 5.Ongoing participation in any other therapeutic clinical trial XML File Identifier: UMHQJ2DEWA4np0qWjAkTqsbNM4k= Page 8/15 01/08/2020 6.Hypersensitivity to the active substance or any of the ingredients of the IMP or placebo 7.Pregnancy 8.Age <18.

2

Amyndas Pharmaceuticals S.A.

18

100

Greece

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

100

The time to clinical improvement, defined as the time from randomization to an improvement of two points or more (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first: Seven-category ordinal scale („Cao-Scale' in accordance to Cao B et al. NEJM 2020): −1: not hospitalized with resumption of normal activities, −2: not hospitalized, but unable to resume normal activities, −3: hospitalized, not requiring supplemental oxygen, −4: hospitalized, requiring supplemental oxygen, −5: hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both, −6: hospitalized, requiring ECMO, invasive mechanical ventilation, or both, and −7: death

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

Phase 2

[{"arm_notes": "", "treatment_id": 81, "treatment_name": "Amy-101", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]