Status:
COMPLETED
Safety and Efficacy of C21 in Subjects With COVID-19
Lead Sponsor:
Vicore Pharma AB
Collaborating Sponsors:
Orphan Reach Ltd.
Conditions:
COVID-19
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 mechanica...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2020
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT04452435
Start Date
July 21 2020
End Date
October 13 2020
Last Update
June 23 2021
Active Locations (9)
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1
Department of Medicine, Civil Hospital and B J Medical College
Ahmedabad, Gujarat, India, 380016
2
Infectious Disease, Metas Adventist Hospital
Surat, Gujarat, India, 395001
3
Clinical Research Department, Basement, Unity Trauma Centre and ICU (Unity Hospital
Surat, Gujarat, India, 395010
4
First Floor Clinical Research Department Rhythm Heart Institute
Vadodara, Gujarat, India, 290022