E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051905 |
E.1.2 | Term | Coronavirus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the efficacy of C21 200 mg daily dose (100 mg b.i.d.) on COVID-19 infection not requiring mechanical ventilation |
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E.2.2 | Secondary objectives of the trial |
To evaluate the following of C21 200 mg daily dose (100 mg b.i.d.) •Effect on inflammation •Safety profile
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1)Written informed consent, consistent with ICH-GCP R2 and local laws, obtained before the initiation of any trial related procedure 2)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 3)Age > = 18 and < = 70 years 4)CRP > = 50 and < = 150 5)Admitted to a hospital or controlled facility (home quarantine is not sufficient) 6)In the opinion of the Investigator, the subject will be able to comply with the requirements of the protocol
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E.4 | Principal exclusion criteria |
1)Any previous experimental treatment for COVID-19 2)Need for non-invasive or mechanical ventilation 3)Concurrent respiratory disease such as COPD, 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 4)Participation in any other interventional trial within 3 months prior to Visit 1 5)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 serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) 6)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 7)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 8)Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I 9)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 10)Pregnant or breast-feeding female subjects 11)Female subjects of childbearing potential not willing to use contraceptive methods as described in Section 5.3.1 12)Male subjects not willing to use contraceptive methods as described in Section 5.3.1 13)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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E.5 End points |
E.5.1 | Primary end point(s) |
•Change from baseline in C-reactive protein (CRP) after treatment with C21 200 mg daily dose (100 mg b.i.d.) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Occuring over the trial period |
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E.5.2 | Secondary end point(s) |
1)Change from baseline in:
•body temperature •IL-6 •IL-10 •TNF •CA125 •Ferritin
2)Number of subjects not in need of oxygen supply 3)Number of subjects not in need of mechanical invasive or non-invasive ventilation 4)Time to need of mechanical invasive or non-invasive ventilation 5)Time on oxygen supply (for those not needing mechanical ventilator treatment) 6)AEs
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Occuring over the trial period |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |