Safety and Efficacy of C21 in Subjects With COVID-19

STATUS

Recruiting
participants needed

100
sponsor

Vicore Pharma AB

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Updated on 19 February 2024

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PCR test

covid-19

SARS

respiratory tract infection

coronavirus infection

respiratory infection

acute respiratory infections

acute respiratory syndrome (sars)

noninvasive ventilation

Summary

This is a randomised, double-blind, placebo-controlled phase 2 trial investigating the safety and efficacy of C21 in subjects who are hospitalised with COVID-19 infection, but not in need of mechanical invasive or non-invasive ventilation.

In total, approximately 100 subjects will be enrolled and randomised to receive twice daily oral administration of either standard of care (SoC) + placebo (N=50) or SoC + C21 (N=50). Subjects will be treated for 7 days.

Details

Condition	Covid 19
Age	18-70 years
Treatment	Placebo, C21
Clinical Study Identifier	NCT04452435
Sponsor	Vicore Pharma AB
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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
Exclusion Criteria
	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, barbituates)
	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)

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Safety and Efficacy of C21 in Subjects With COVID-19