Clinical trial NCT04452435: Safety and Efficacy of C21 in Subjects With COVID-19
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: COVID-19
Lead sponsor: Vicore Pharma AB
Sponsor class: INDUSTRY
Collaborators: name: Orphan Reach Ltd.
First posted: 2020-06-30
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility 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 \< 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)

Primary outcomes:
measure: Change From Baseline in C-reactive Protein (CRP) After Treatment With C21 200 mg Daily Dose (100 mg b.i.d.)
timeFrame: Treatment period of 7 days (Day 1 to Day 8)
Secondary outcomes:
measure: Change From Baseline in Body Temperature
timeFrame: Treatment period of 7 days ((Day 1 to Day 8)
measure: Change From Baseline in IL-6
timeFrame: Treatment period of 7 days (Day 1 to Day 8)
measure: Change From Baseline in IL-10
timeFrame: Treatment period of 7 days (Day 1 to Day 8)
measure: Change From Baseline in TNF
timeFrame: Treatment period of 7 days (Day 1 to Day 8)
measure: Change From Baseline in CA125
timeFrame: Treatment period of 7 days (Day 1 to Day 8)
measure: Change From Baseline in Ferritin
timeFrame: Treatment period of 7 days (Day 1 to Day 8)
measure: Number of Subjects Not in Need of Oxygen Supply
timeFrame: End-of treatment, Day 7 or 8
measure: Number of Subjects Not in Need of Mechanical Invasive or Non-invasive Ventilation
timeFrame: Treatment period of 7 days (Day 1 to Day 8)
measure: Time to Need of Mechanical Invasive or Non-invasive Ventilation
timeFrame: Treatment period of 7 days
measure: Time on Oxygen Supply (for Those Not Needing Mechanical Invasive or Non-invasive Ventilation)
timeFrame: Treatment period of 7 days (Day 1 to Day 8)
measure: Adverse Events
timeFrame: Day 1 to end-of-trial (Visit 9)
Other outcomes:
Locations:
city: Ahmadabad
country: India
facility: Department of Medicine, Civil Hospital and B J Medical College
state: Gujarat
city: Surat
country: India
facility: Infectious Disease, Metas Adventist Hospital
state: Gujarat
city: Surat
country: India
facility: Clinical Research Department, Basement, Unity Trauma Centre and ICU (Unity Hospital
state: Gujarat
city: Vadodara
country: India
facility: First Floor Clinical Research Department Rhythm Heart Institute
state: Gujarat
city: Mumbai
country: India
facility: Internal Medicine S.L. Raheja Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Department of Medicine, Government Medical College and Hospital
state: Maharashtra
city: Pune
country: India
facility: Neuro Critical Care, Grant Medical Foundation Ruby Hall Clinic
state: Maharashtra
city: Pune
country: India
facility: Department of Medicine, Noble Hospitals Pvt. Ltd
state: Maharashtra
city: London
country: United Kingdom
facility: Respiratory Medicine, University College Hospital
Study officials:
affiliation: Respiratory Medicine, University College Hospital
name: Joanna Porter, MD
role: PRINCIPAL_INVESTIGATOR
References: