COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000264-29/CZ

Vicore Pharma AB - Head of Clinical Operations

anne-katrine.cohrt@vicorepharma.com

2021-06-03

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Age ≥18 years or the legal age of consent 2. Hospitalized due to SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) test, documented by either of the following: a. PCR positive in sample collected <72 hours prior to randomization (Visit 2), OR b. PCR positive in sample collected ≥72 hours and ≤7 days prior to randomization, documented inability to obtain a repeat sample AND progressive disease suggestive of ongoing SARS-CoV-2 infection. 3. A score of 5 or 6 on the 8-point ordinal scale: a. Score 5: Hospitalized, requiring supplemental oxygen. b. Score 6: Hospitalized, on non-invasive ventilation or high-flow oxygen device. 4. Contraceptive use by men and women of childbearing potential 5. Written informed consent obtained before the initiation of any trial-related procedure. 6. Capable of giving signed informed consent

1. Concurrent serious medical condition which in the opinion of the investigator constitutes a risk or a contraindication for the participation in the trial or that could interfere with the trial objectives, conduct or evaluation. 2. Known, active hepatitis B, C, or human immunodeficiency virus (HIV) infection 3. Impaired hepatic function (i.e., Child-Pugh class A or B) 4. Severe renal impairment (i.e., estimated glomerular filtration rate (eGFR) ≤30 ml/min/1.73 m2). 5. COVID-19 symptom onset >14 days prior to screening (Visit 1). 6. Hospitalized due to COVID-19 for >72 hours at screening (Visit 1). 7. Invasive mechanical ventilation or ECMO within 72 hours of screening (Visit 1) 8. Expected need for invasive mechanical ventilation or ECMO in <48 hours in the opinion of the investigator. 9. Moderate to severe ARDS (e.g., PaO2/FiO2 ≤200 mmHg), if on non-invasive mechanical ventilation or high-flow oxygen. 10. Pregnant or breast-feeding female subjects. 11. Any previous and concurrent experimental treatment for COVID-19 that is not considered local SoC. 12. Treatment with the medications listed below within 1 week prior to screening (Visit 1) or anticipated need for such medication during the participation in this trial: a. Strong Cytochrome P450 (CYP) 3A4 inducers. b. P-glycoprotein (P-gp) substrates with narrow therapeutic index. c. High dose BCRP sensitive substrates. d. Warfarin. e. Sulphasalazine or rosuvastatin. 13. Current or previous participation in any other clinical trial where the subject has received a dose of IMP within 1 month or 5 half-lives of the IMP, whichever is longest, prior to screening (Visit 1). 14. Positive pregnancy test 15. Abnormal laboratory value at screening (Visit 1) indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator.

2

Vicore Pharma AB

18

100

Argentina;Brazil;Colombia;India;Peru;Poland;South Africa;United States;Sweden

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

60

• Proportion of subjects discharged from hospital and free of supplemental oxygen at Day 15.

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

Phase 3

[{"arm_notes": null, "treatment_id": 243, "treatment_name": "C21", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": null, "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]