NCT04452435CompletedPhase 2
A Randomised, Double-blind, Placebo-controlled, Phase 2 Trial Investigating the Safety and Efficacy of C21 in Hospitalised Subjects With COVID-19 Infection Not Requiring Mechanical Ventilation
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Vicore Pharma AB
- Enrollment
- 206
- Locations
- 9
- Primary Endpoint
- Change From Baseline in C-reactive Protein (CRP) After Treatment With C21 200 mg Daily Dose (100 mg b.i.d.)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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, barbiturates)
- •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)
Arms & Interventions
C21 100 mg twice daily
Experimental
Oral C21 treatment 100 mg twice daily for 7 days
Intervention: C21 (Drug)
Placebo
Placebo Comparator
Oral placebo treatment 100 mg twice daily for 7 days
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline in C-reactive Protein (CRP) After Treatment With C21 200 mg Daily Dose (100 mg b.i.d.)
Time Frame: Treatment period of 7 days (Day 1 to Day 8)
Change in C-reactive protein (CRP) from baseline to the average of the last two assessments in the treatment period
Secondary Outcomes
- Change From Baseline in Body Temperature(Treatment period of 7 days ((Day 1 to Day 8))
- Change From Baseline in IL-10(Treatment period of 7 days (Day 1 to Day 8))
- Time to Need of Mechanical Invasive or Non-invasive Ventilation(Treatment period of 7 days)
- Change From Baseline in TNF(Treatment period of 7 days (Day 1 to Day 8))
- Change From Baseline in IL-6(Treatment period of 7 days (Day 1 to Day 8))
- Change From Baseline in CA125(Treatment period of 7 days (Day 1 to Day 8))
- Change From Baseline in Ferritin(Treatment period of 7 days (Day 1 to Day 8))
- Number of Subjects Not in Need of Oxygen Supply(End-of treatment, Day 7 or 8)
- Time on Oxygen Supply (for Those Not Needing Mechanical Invasive or Non-invasive Ventilation)(Treatment period of 7 days (Day 1 to Day 8))
- Number of Subjects Not in Need of Mechanical Invasive or Non-invasive Ventilation(Treatment period of 7 days (Day 1 to Day 8))
- Adverse Events(Day 1 to end-of-trial (Visit 9))
Investigators
Study Sites (9)
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