Safety and Efficacy of C21 in Subjects With COVID-19

Vicore Pharma

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Drug: Placebo; Drug: C21

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04452435

2020-001502-38 (EudraCT Number)

VP-C21-006

Details and patient eligibility

About

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.

Enrollment: 206 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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206 participants in 2 patient groups, including a placebo group

C21 100 mg twice daily

Experimental group

Description:

Oral C21 treatment 100 mg twice daily for 7 days

Treatment:

Drug: C21

Placebo

Placebo Comparator group

Description:

Oral placebo treatment 100 mg twice daily for 7 days

Treatment:

Drug: Placebo