Phase 2
N=106
Safety and Efficacy of C21 in Subjects With COVID-19
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04452435 ↗Enrolled (actual)
106
Serious AEs
2.9%
Results posted
Apr 2021
Primary outcome: Primary: Change From Baseline in C-reactive Protein (CRP) After Treatment With C21 200 mg Daily Dose (100 mg b.i.d.) — 0.19; 0.22 mg/L — p==0.4891
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- C21 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vicore Pharma AB
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in C-reactive Protein (CRP) After Treatment With C21 200 mg Daily Dose (100 mg b.i.d.) |
0.19; 0.22 | =0.4891 |
| SECONDARY Change From Baseline in Body Temperature |
-0.11; -0.34 | =0.0492 sig |
| SECONDARY Change From Baseline in IL-6 |
0.73; 0.73 | =0.9923 |
| SECONDARY Change From Baseline in IL-10 |
0.66; 0.73 | =0.5355 |
| SECONDARY Change From Baseline in TNF |
0.91; 1.01 | =0.4738 |
| SECONDARY Change From Baseline in CA125 |
1.16; 1.17 | =0.9418 |
| SECONDARY Change From Baseline in Ferritin |
0.75; 0.74 | =0.9733 |
| SECONDARY Number of Subjects Not in Need of Oxygen Supply |
37; 30 | =0.0568 |
| SECONDARY Number of Subjects Not in Need of Mechanical Invasive or Non-invasive Ventilation |
50; 53 | =0.6088 |
| SECONDARY Time to Need of Mechanical Invasive or Non-invasive Ventilation |
60.0; 77.925 | =0.5757 |
| SECONDARY Time on Oxygen Supply (for Those Not Needing Mechanical Invasive or Non-invasive Ventilation) |
5.0; 5.0 | =0.8588 |
| SECONDARY Adverse Events |
31; 37 | — |
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.
Eligibility Criteria
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 18 and 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)
- 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)
Data sourced from ClinicalTrials.gov (NCT04452435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.