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COVID-19Phase 2NCT04536090

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

A Phase 2 study testing Isoquercetin (IQC-950AN) in people with COVID-19, run by Institut de Recherches Cliniques de Montreal.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
Isoquercetin (IQC-950AN)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2022to Jun 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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;
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  • 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

About this study

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)

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.

Read the detailed 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.

Conditions
COVID-19
Being tested
Isoquercetin (IQC-950AN)
Keywords
Isoquercetin, Quercetin, Antiviral Agents
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Isoquercetin (IQC-950AN)Drug

    Also called IQC-950AN

    Isoquercetin will be administered by mouth twice daily for 28 days

Study groups in NCT04536090
Study groupRoleWhat they receive
Isoquercetin (IQC-950AN)Experimental1000 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)
Receives: Drug: Isoquercetin (IQC-950AN)
Standard of careNo interventionThis arm will receive standard of care based on national guidelines. This may change as new information regarding best practice emerges.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Progression

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

    Measured: 28 days

Secondary outcomes (17)

  1. 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)

    Measured: 28 days

  2. 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)

    Measured: 28 days

  3. 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)

    Measured: 28 days

  4. 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)

    Measured: 28 days

  5. Disease Recovery

    Disease recovery is defined as WHO Clinical Progression Scale score of ≤2

    Measured: 28 days

  6. Change in WHO Clinical Progression Scale score

    Change in score from baseline to day 28

    Measured: 28 days

  7. Incidence of all-cause mortality

    All-cause mortality calculated at Day 30

    Measured: 30 days

  8. Progression to supplementary oxygen requirement

    If the patient required supplementary oxygen during hospitalization

    Measured: 14 days

  9. Incidence of mechanical ventilation

    If the patient required mechanical ventilation during hospitalization

    Measured: 14 days

  10. Incidence of ICU admission

    If the patient was admitted to ICU

    Measured: 14 days

  11. Time to hospital discharge

    Length of time in hospital prior to being discharged

    Measured: 29 days

  12. Changes in serum C reactive protein levels (CRP)

    Changes in serum CRP levels

    Measured: 29 days

  13. Changes in D-dimer levels

    Changes in D-dimer levels

    Measured: 29 days

  14. 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

    Measured: 29 days

  15. Changes in LDL-cholesterol

    Changes in LDL-cholesterol

    Measured: 29 days

  16. Changes in creatinine

    Changes in creatinine

    Measured: 29 days

  17. Changes in liver enzymes

    Changes in liver enzymes

    Measured: 29 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2020
  2. Study startJan 2022 (estimated)
  3. Primary completionDec 2022 (estimated)
  4. Study completionJun 2023 (estimated)

Why it stopped: Never started

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04536090
Sponsor's protocol ID
IRCM-IQC-001
Status last verified
Mar 2025
First submitted
31 Aug 2020
Last updated
24 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32539990

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Isoquercetin (IQC-950AN) in people with COVID-19, run by Institut de Recherches Cliniques de Montreal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Progression (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04536090, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.

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