A Trial to Investigate Recovery From COVID-19 With C21 in Adult Subjects

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is a randomized, double-blind, placebo-controlled, parallel-group, 2-arm, multicenter trial to evaluate the efficacy and safety of C21 versus placebo as add on to SoC in adult subjects with COVID-19.

The trial will enroll a total of 600 randomized subjects, 300 per arm (oral C21 100 mg twice a day (b.i.d.) or placebo for 14 days) according to the 1:1 randomization.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vicore Pharma AB

Criteria

Inclusion Criteria:

1. Age ≥18 years or the legal age of consent in the jurisdiction in which the trial is taking place at the time of signing the informed consent

2. Hospitalized due to Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection confirmed by polymerase chain reaction test, documented by either of the following:

1. Polymerase chain reaction (PCR) positive in sample collected <72 hours prior to randomization (Visit 2); OR

2. PCR positive in sample collected ≥72 hours and ≤7 days prior to randomization, documented inability to obtain a repeat sample AND progressive disease suggestive of ongoing SARS-CoV-2 infection

3. A score of 5 or 6 on the 8-point ordinal scale:

1. Score 5: Hospitalized, requiring supplemental oxygen

2. Score 6: Hospitalized, on non-invasive ventilation or high-flow oxygen device

4. Contraceptive use by men and women of childbearing potential consistent with local regulations regarding the methods of contraception for those participating in clinical studies

5. Written informed consent, consistent with International Council for Harmonization Good Clinical Practice Revision 2 and local laws, obtained before the initiation of any trial- related procedure

6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol

Exclusion Criteria:

1. Concurrent serious medical condition which in the opinion of the investigator constitutes a risk or a contraindication for the participation in the trial or that could interfere with the trial objectives, conduct or evaluation

2. Known, active hepatitis B, C, or human immunodeficiency virus infection (i.e., human immunodeficiency virus (HIV) with a cluster of differentiation 4 (CD4) count <500 cells/mm³)

3. Impaired hepatic function (i.e., Child-Pugh class A or B)

4. Severe renal impairment (i.e., estimated glomerular filtration rate (eGFR) ≤30 ml/min/1.73 m2)

5. Corona virus disease (COVID)-19 symptom onset >14 days prior to screening

6. Hospitalized due to COVID-19 for >72 hours at screening

7. Invasive mechanical ventilation or ECMO within 72 hours of screening

8. Expected need for invasive mechanical ventilation or ECMO in <48 hours in the opinion of the investigator

9. Moderate to severe ARDS (e.g., partial pressure of oxygen (PaO2)/FiO2 ≤200 mmHg), if on non-invasive mechanical ventilation or high-flow oxygen

10. Pregnant or breast-feeding female subjects

11. Any previous and concurrent experimental treatment for COVID-19 that is not considered local SoC.

12. Treatment with the medications listed below within 1 week prior to screening or anticipated need for such medication during the participation in this trial:

1. Strong Cytochrome P450 (CYP) 3A4 inducers.

2. P-glycoprotein (P-gp) substrates with narrow therapeutic index.

3. High dose Breast Cancer Resistance Protein (BCRP) sensitive substrates.

4. Warfarin.

5. Sulphasalazine or rosuvastatin.

13. Current or previous participation in any other clinical trial where the subject has received a dose of IMP within 1 month or 5 half-lives of the investigational medicinal product (IMP), whichever is longest, prior to screening

14. Positive pregnancy test

15. Abnormal laboratory value at screening indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator