This is an open-label, randomized, multi-centre study where hospitalized subjects will berandomized in a 2:1 ratio to receive Isoquercetin (IQC-950AN) in addition to standard ofcare or standard of care only for 28 days following confirmation of a COVID-19 infection.
The primary purpose of this randomized study will be to evaluate the effect of
Isoquercetin (IQC-950AN) treatment on disease progression (defined as ≥ 6 on the World
Health Organization (WHO) clinical progression scale) when given to subjects with
confirmed COVID-19 in addition to standard of care. The secondary purpose of this study
is to evaluate the effect of Isoquercetin (IQC-950AN) treatment on the reduction of
severe acute respiratory coronavirus 2 (SARS-CoV-2) viral titers in these subjects and
their recovery. In addition, certain parameters which may help elucidate the mechanism of
action (sLDLR, PCSK9, sACE2, D-dimers and CRP) will be followed. The safety of
Isoquercetin (IQC-950AN) will be evaluated at each visit. Subjects will be randomized to
receive treatment for 28 days and then will return 30 days following the discontinuation
of treatment for a final safety visit.
The results of this study will be used to design an adequately powered randomized
controlled pivotal study to evaluate the efficacy and safety of Isoquercetin (IQC-950AN)
in all or a subset of subjects with confirmed COVID-19.
Drug: Isoquercetin (IQC-950AN)
Isoquercetin will be administered by mouth twice daily for 28 days
Other Name: IQC-950AN
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
Michel Chrétien, FRS MD FRCP©
1-833-705-0648
michel.chretien@ircm.qc.ca
Michel Chrétien, FRS MD FRCP©, Study Director
Montreal Clinical Research Institute