Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: C21: IMP will be administered twice daily orally for 7 days from Visit 2 to Visit 8 as follows:
1. Morning dose: Two 50 mg capsules to be taken with a glass of water after minimum 2 hou
Sponsors
Vicore Pharma AB
QED Clinical Services India Private Limited
Eligibility
Inclusion criteria
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 less than 4 days before Visit 1 with signs of an acute respiratory infection. 3) Age more than equal to 18 and less than equal to 70 years. 4) CRP more than 50 and less than 150 mg/l. 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.
Exclusion criteria
Exclusion criteria: 1) Any previous experimental treatment for COVID-19 2) Need for mechanical invasive or non-invasive ventilation 3) 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 4) Participation in any other interventional trial within 3 months prior to Visit 1 5) Any of the following findings at Visit 1: a. Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus 1 and 2 antigen/antibody (HIV 1 and 2 Ag/Ab) b Positive pregnancy test (see Section 8.2.3). 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: a. Strong Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. Johnâ??s Wort, phenobarbital, rifabutin, carbamazepine, anti HIV drugs, barbituates) b. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in C-reactive protein (CRP) after treatment with C21 200 mg daily dose (100 mg b.i.d.).Timepoint: The primary endpoint will be the change in CRP from baseline to the average of the last 2 assessments during the treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change from baseline in: a. Body temperature b. IL-6 c IL-10 d. TNF e. CA125 f. 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 invasive or non-invasive ventilation) 6) Adverse eventsTimepoint: Secondary (continuous) endpoints such as body temperature and pre-specified laboratory values and biomarkers will be summarised by visit and for the change over trial by descriptive statistics. The change from baseline will be compared using similar ANCOVA models as the primary endpoint.;Exploratory Endpoint: Blood samples will be stored for potential future analyses of biomarkers reflecting inflammation and lung injury.Timepoint: Biomarker data will be exploratory and the analyses data-driven. Collected data will be visualised graphically and summarised descriptively | — |
Countries
India, Russian Federation, Ukraine, United Kingdom
Contacts
Public ContactMr Gajendrasinh Chanchu
QED Clinical Services India Private Limited
Outcome results
None listed