COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-005979-12/GR

XENOTHERA - Chief Operating Officer

bernard.vanhove@xenothera.com

2021-02-08

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

I1) Male or female patient aged 18 years or over, weighing >50 Kg and <120 Kg, at the time of signing the informed consent, I2) Patient presenting in a specialized or an emergency unit I3) Patient presenting signs of pneumonia evidenced by at least 1 of the following: auscultation, chest X-Ray, CT scan OR presenting COVID-19 related symptoms having started less than 10 days prior to screening visit, including at least 2 of the following: fever, cough, sore throat or nasal discharge, dyspnea (shortness of breath), thoracic pain, headache or fatigue, myalgia, anosmia, dysgeusia, diarrhea, nausea I4) Patient with SpO2 > 90% (at ambient air) I5) Patient with a first positive SARS-CoV-2 test (RT-PCR, RT-qPCR or antigen test) in the last 10 days or at screening I6) Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at screening and use a highly effective1 birth control until 90 days after the administration of study drug I7) Non-vasectomized male patients having a female partner of childbearing potential must agree to use a highly effective method of contraception until 90 days after the administration of study drug, I8) Patient capable of giving signed informed consent.

E1) Patient with a positive SARS CoV-2 test (RT-PCR, RT-qPCR or antigen test) of more than 10 days before the screening visit E2) Patient with multiorgan failure E3) Patient requiring immediate Intensive Care Unit (ICU) hospitalization E4) Patient participating in another clinical trial with an investigative agent E5) Pregnancy or breastfeeding

2

XENOTHERA

18

100

Bulgaria;Greece;Romania;Spain;Turkey;France

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

153

The primary endpoint is the proportion of patients with an aggravation of COVID-19 within 8 days after treatment. The aggravation is defined as a worsening of the score of at least 1 point on the WHO 7-point ordinal scale compared to the score on the WHO-7 ordinal scale at randomization.

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

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 1389, "treatment_name": "Xav-19", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]