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

NCT04536090 | Withdrawn Phase 2 DMC

• 1 other identifier: IRCM-IQC-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

COVID-19

Keywords

Isoquercetin; Quercetin; Antiviral Agents

Outcome Measures

Primary Outcomes (1)

• Disease Progression

  Disease progression is defined as WHO Clinical Progression Scale ≥6, at any time between Day 1 and Day 28

  28 days

Secondary Outcomes (17)

• Changes in viral load from baseline to end of treatment - Mean viral load

  28 days

• Changes in viral load from baseline to end of treatment - Area under the viral load vs. time profiles

  28 days

• Changes in viral load from baseline to end of treatment - Time profile of viral load

  28 days

• Changes in viral load from baseline to end of treatment - Percentage of patients that are viral negative

  28 days

• Disease Recovery

  28 days

Study Arms (2)

Isoquercetin (IQC-950AN)

EXPERIMENTAL

1000 mg Isoquercetin b.i.d. on day 1, then 500 mg Isoquercetin b.i.d. for 27 more days, plus standard of care (as defined below)

Drug: Isoquercetin (IQC-950AN)

Standard of care

NO INTERVENTION

This arm will receive standard of care based on national guidelines. This may change as new information regarding best practice emerges.

Interventions

Isoquercetin (IQC-950AN) DRUG

Isoquercetin will be administered by mouth twice daily for 28 days

Also known as: IQC-950AN

Isoquercetin (IQC-950AN)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must exhibit symptoms of COVID-19 disease at screening;
• Patients must be 18 years of age or older, of either gender;
• Patients must have a documented SARS-CoV-2 RNA-positive test virus within 3 days prior to randomization;
• 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;
• 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);
• 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.
• Patients must have the ability to understand and give informed consent, which can be verbal with a witness, according to local requirements;
• Patients deemed capable of adequate compliance including attending scheduled visits for the duration of the study;
• Patients must be able to swallow the study drug capsules

You may not qualify if:

• 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;
• Patients with known chronic kidney disease with estimated creatinine clearance \< 50 mL/minute or need for dialysis;
• 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;
• Patients who are severely hypotensive defined as needing hemodynamic pressors to maintain blood pressure;
• Patients with moderate or severe thrombocytopenia (platelet count \<100 × 10⁹/L);
• Patients who are breast-feeding an infant or child;
• Patients who are pregnant or unwilling to use an appropriate form of contraception, except for heterosexual celibacy
• 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;
• Any reason the investigator suspects that data collected from this patient would be incomplete or of poor quality

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead
• Pharmascience Inc.: collaborator
• SCiAN Services, Inc.: collaborator
• Quercis Pharma AG: collaborator

Related 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.

  PMID: 32539990 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

isoquercitrin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michel Chrétien, FRS MD FRCP©

  Montreal Clinical Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 2, 2020
• Study Start: January 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share