COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04452435

Mimi Flensburg

mimi.flensburg@vicorepharma.com

2020-06-30

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: written informed consent, consistent with ich-gcp r2 and local laws, obtained before the initiation of any trial related procedure diagnosis of coronavirus (sars-cov)-2 infection confirmed by polymerase chain reaction (pcr) test < 4 days before visit 1 with signs of an acute respiratory infection age > 18 and < 70 years crp > 50 and < 150 mg/l admitted to a hospital or controlled facility (home quarantine is not sufficient) in the opinion of the investigator, the subject will be able to comply with the requirements of the protocol

any previous experimental treatment for covid-19 need for mechanical invasive or non-invasive ventilation concurrent respiratory disease such as copd (chronic obstructive pulmonary disease), ipf and/or intermittent, persistent or more severe asthma requiring daily therapy or any subjects that have had an asthma flare requiring corticosteroids in the 4 weeks (28 days) prior to covid-19 diagnosis participation in any other interventional trial within 3 months prior to visit 1 any of the following findings at visit 1: positive results for hepatitis b surface antigen (hbsag), hepatitis c virus antibody (hcvab) or human immunodeficiency virus 1+2 antigen/antibody (hiv 1+2 ag/ab positive pregnancy test (see section 8.2.3) clinically significant abnormal laboratory value at visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator concurrent serious medical condition with special attention to cardiac or ophthalmic conditions (e.g. contraindications to cataract surgery), which in the opinion of the investigator makes the subject inappropriate for this trial malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade i treatment with any of the medications listed below within 1 week prior to visit 1: strong cytochrome p450 (cyp) 3a4 inducers (e.g. rifampicin, phenytoin, st. john's wort, phenobarbital, rifabutin, carbamazepine, anti hiv drugs, barbiturates) warfarin pregnant or breast-feeding female subjects female subjects of childbearing potential not willing to use contraceptive methods as described in section 5.3.1 male subjects not willing to use contraceptive methods as described in section 5.3.1 subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)

2

Vicore Pharma AB

18

70

India;United Kingdom

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

206

Change From Baseline in C-reactive Protein (CRP) After Treatment With C21 200 mg Daily Dose (100 mg b.i.d.)

None

Phase 2

[{"arm_notes": "Results also available for EUCTR2020-001502-38: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001502-38/results", "treatment_id": 86, "treatment_name": "Angiotensin receptor blocker (arb)", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Results also available for EUCTR2020-001502-38: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001502-38/results", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]