Safety and Efficacy of C21 in Subjects With COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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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
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COVID-19

Intervention / Treatment
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* Drug: C21
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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) 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C21 100 mg twice daily<br>Oral C21 treatment 100 mg twice daily for 7 days | Drug: C21<br>* C21<br>|
| Placebo Comparator: Placebo<br>Oral placebo treatment 100 mg twice daily for 7 days | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in C-reactive Protein (CRP) After Treatment With C21 200 mg Daily Dose (100 mg b.i.d.) | Change in C-reactive protein (CRP) from baseline to the average of the last two assessments in the treatment period | Treatment period of 7 days (Day 1 to Day 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Body Temperature | Change in body temperature from baseline to the average of the last two assessments in the treatment period | Treatment period of 7 days ((Day 1 to Day 8) | 
| Change From Baseline in IL-6 | Change in IL-6 from baseline to the average of the last two assessments during the treatment period | Treatment period of 7 days (Day 1 to Day 8) | 
| Change From Baseline in IL-10 | Change in IL-10 from baseline to the average of the last two assessments during the treatment period | Treatment period of 7 days (Day 1 to Day 8) | 
| Change From Baseline in TNF | Change in TNF from baseline to the average of the last two assessments during the treatment period. | Treatment period of 7 days (Day 1 to Day 8) | 
| Change From Baseline in CA125 | Change in CA125 from baseline to the average of the last two assessments in the treatment period | Treatment period of 7 days (Day 1 to Day 8) | 
| Change From Baseline in Ferritin | Change in Ferritin from baseline to the average of the last two assessments during the treatment period. | Treatment period of 7 days (Day 1 to Day 8) | 
| Number of Subjects Not in Need of Oxygen Supply | Number of subjects not in need of oxygen supply at the end of treatment | End-of treatment, Day 7 or 8 | 
| Number of Subjects Not in Need of Mechanical Invasive or Non-invasive Ventilation | Number of subjects not in need of mechanical invasive or non-invasive ventilation during the treatment period | Treatment period of 7 days (Day 1 to Day 8) | 
| Time to Need of Mechanical Invasive or Non-invasive Ventilation | Time to need of mechanical invasive or non-invasive ventilation during treatment period | Treatment period of 7 days | 
| Time on Oxygen Supply (for Those Not Needing Mechanical Invasive or Non-invasive Ventilation) | Time on oxygen supply during the treatment period (for those not needing mechanical invasive or non-invasive ventilation) | Treatment period of 7 days (Day 1 to Day 8) | 
| Adverse Events | Adverse events were reported from signing of informed consent until end-of-trial visit. No AEs were reported from signing of informed consent until randomization, except for 2 fatal SAEs described under Adverse events. | Day 1 to end-of-trial (Visit 9) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19