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

COVID-19 Clinical Trial

Official title:

An Open-Label Randomized Study of Isoquercetin (IQC-950AN) Plus Standard of Care Versus Standard of Care Only for the Treatment of 2019 Novel Coronavirus Disease (COVID-19)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04536090
• Other study ID #: IRCM-IQC-001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 2022
• Est. completion date: June 2023

Study information

• Verified date: August 2021
• Source: Institut de Recherches Cliniques de Montreal
• Contact: Michel Chrétien, FRS MD FRCP©
• Phone: 1-833-705-0648
• Email: michel.chretien[@]ircm.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 × 10?/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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Isoquercetin (IQC-950AN)
Isoquercetin will be administered by mouth twice daily for 28 days

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Institut de Recherches Cliniques de Montreal	Pharmascience Inc., Quercis Pharma AG, SCiAN Services, Inc.

References & Publications (1)

WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection. A minimal common outcome measure set for COVID-19 clinical research. Lancet Infect Dis. 2020 Aug;20(8):e192-e197. doi: 10.1016/S1473-3099(20)30483-7. Epub 2020 Jun 12. Review. Erratum in: Lancet Infect Dis. 2020 Oct;20(10):e250. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Progression	Disease progression is defined as WHO Clinical Progression Scale =6, at any time between Day 1 and Day 28	28 days
Secondary	Changes in viral load from baseline to end of treatment - Mean viral load	Viral load of SARS-CoV-2 RNA (# of viral copies) assessed by quantitative reverse transcription polymerase chain reaction (qRT-PCR)	28 days
Secondary	Changes in viral load from baseline to end of treatment - Area under the viral load vs. time profiles	Viral load of SARS-CoV-2 RNA (# of viral copies) assessed by quantitative reverse transcription polymerase chain reaction (qRT-PCR)	28 days
Secondary	Changes in viral load from baseline to end of treatment - Time profile of viral load	Viral load of SARS-CoV-2 RNA (# of viral copies) assessed by quantitative reverse transcription polymerase chain reaction (qRT-PCR)	28 days
Secondary	Changes in viral load from baseline to end of treatment - Percentage of patients that are viral negative	Defined as below the level of quantitation of the assay (qRT-PCR). Viral load of SARS-CoV-2 RNA (# of viral copies) assessed by quantitative reverse transcription polymerase chain reaction (qRT-PCR)	28 days
Secondary	Disease Recovery	Disease recovery is defined as WHO Clinical Progression Scale score of =2	28 days
Secondary	Change in WHO Clinical Progression Scale score	Change in score from baseline to day 28	28 days
Secondary	Incidence of all-cause mortality	All-cause mortality calculated at Day 30	30 days
Secondary	Progression to supplementary oxygen requirement	If the patient required supplementary oxygen during hospitalization	14 days
Secondary	Incidence of mechanical ventilation	If the patient required mechanical ventilation during hospitalization	14 days
Secondary	Incidence of ICU admission	If the patient was admitted to ICU	14 days
Secondary	Time to hospital discharge	Length of time in hospital prior to being discharged	29 days
Secondary	Changes in serum C reactive protein levels (CRP)	Changes in serum CRP levels	29 days
Secondary	Changes in D-dimer levels	Changes in D-dimer levels	29 days
Secondary	Changes in soluble low-density lipoprotein receptor (sLDLR) expression and proprotein convertase subtilisin/kexin type 9 (PCSK9) and soluble angiotensin converting enzyme 2 (sACE2) levels	Changes in sLDLR expression, and PCSK9 and sACE2 levels	29 days
Secondary	Changes in LDL-cholesterol	Changes in LDL-cholesterol	29 days
Secondary	Changes in creatinine	Changes in creatinine	29 days
Secondary	Changes in liver enzymes	Changes in liver enzymes	29 days