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.
Drug: C21
C21
Drug: Placebo
Placebo
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 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:
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:
- 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)
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:
1. Strong Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. John's
Wort, phenobarbital, rifabutin, carbamazepine, anti HIV drugs, barbiturates)
2. 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)
Department of Medicine, Civil Hospital and B J Medical College
Ahmadabad, Gujarat, India
Infectious Disease, Metas Adventist Hospital
Surat, Gujarat, India
Clinical Research Department, Basement, Unity Trauma Centre and ICU (Unity Hospital
Surat, Gujarat, India
First Floor Clinical Research Department Rhythm Heart Institute
Vadodara, Gujarat, India
Internal Medicine S.L. Raheja Hospital
Mumbai, Maharashtra, India
Department of Medicine, Government Medical College and Hospital
Nagpur, Maharashtra, India
Neuro Critical Care, Grant Medical Foundation Ruby Hall Clinic
Pune, Maharashtra, India
Department of Medicine, Noble Hospitals Pvt. Ltd
Pune, Maharashtra, India
Respiratory Medicine, University College Hospital
London, United Kingdom
Joanna Porter, MD, Principal Investigator
Respiratory Medicine, University College Hospital