Study of Isoquercetin (IQC-950AN) Plus Standard of Care Versus Standard of Care Only for the Treatment of COVID-19

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, randomized, multi-centre study where hospitalized subjects will be randomized in a 2:1 ratio to receive Isoquercetin (IQC-950AN) in addition to standard of care or standard of care only for 28 days following confirmation of a COVID-19 infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Recherches Cliniques de Montreal
• Collaborators: Pharmascience Inc.; Quercis Pharma AG; SCiAN Services, Inc.

Criteria

Inclusion Criteria:

1. Patients must exhibit symptoms of COVID-19 disease at screening;

2. Patients must be 18 years of age or older, of either gender;

3. Patients must have a documented SARS-CoV-2 RNA-positive test virus within 3 days prior to randomization;

4. Patients must be admitted (or under observation to be admitted) to a controlled facility or hospital to receive standard-of-care for COVID-19 disease;

5. Patient's health status must be 3 (if hospitalized for comorbidities), 4, or 5 on the WHO clinical progression scale defined as hospitalized moderate disease (no oxygen therapy or oxygen by mask or nasal prongs);

6. If female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception, must be: practicing a highly effective method of birth control during the study and through 30 days after the last dose of the study medication.

7. Patients must have the ability to understand and give informed consent, which can be verbal with a witness, according to local requirements;

8. Patients deemed capable of adequate compliance including attending scheduled visits for the duration of the study;

9. Patients must be able to swallow the study drug capsules

Exclusion Criteria:

1. Patients with a history of allergy or anaphylaxis to ingredients in Isoquercetin (IQC-950AN) including known intolerance of niacin or ascorbic acid or known glucose-6-phosphate dehydrogenase (G6PD) deficiency;

2. Patients with known chronic kidney disease with estimated creatinine clearance < 50 mL/minute or need for dialysis;

3. Patients receiving an intensified dose regimen of low molecular weight heparin (LMWH) or unfractionated heparin (defined as doses of LMWH or unfractionated heparin greater than those approved for thromboprophylaxis) or dual antiplatelet therapy;

4. Patients who are severely hypotensive defined as needing hemodynamic pressors to maintain blood pressure;

5. Patients with moderate or severe thrombocytopenia (platelet count <100 × 10⁹/L);

6. Patients who are breast-feeding an infant or child;

7. Patients who are pregnant or unwilling to use an appropriate form of contraception, except for heterosexual celibacy

8. Any other condition that, in the opinion of the investigator, may adversely affect the patient's ability to complete this study or its measures, or pose a significant risk to the patient;

9. Any reason the investigator suspects that data collected from this patient would be incomplete or of poor quality