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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04536090
Recruitment Status : Not yet recruiting
First Posted : September 2, 2020
Last Update Posted : October 26, 2020
Sponsor:
Collaborators:
Pharmascience Inc.
SCiAN Services, Inc.
Quercis Pharma AG
Information provided by (Responsible Party):
Institut de Recherches Cliniques de Montreal

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Isoquercetin (IQC-950AN) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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)
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: Isoquercetin (IQC-950AN)
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)
Isoquercetin will be administered by mouth twice daily for 28 days
Other Name: IQC-950AN

No Intervention: Standard of care
This arm will receive standard of care based on national guidelines. This may change as new information regarding best practice emerges.



Primary Outcome Measures :
  1. Disease Progression [ Time Frame: 28 days ]
    Disease progression is defined as WHO Clinical Progression Scale ≥6, at any time between Day 1 and Day 28


Secondary Outcome Measures :
  1. Changes in viral load from baseline to end of treatment - Mean viral load [ Time Frame: 28 days ]
    Viral load of SARS-CoV-2 RNA (# of viral copies) assessed by quantitative reverse transcription polymerase chain reaction (qRT-PCR)

  2. Changes in viral load from baseline to end of treatment - Area under the viral load vs. time profiles [ Time Frame: 28 days ]
    Viral load of SARS-CoV-2 RNA (# of viral copies) assessed by quantitative reverse transcription polymerase chain reaction (qRT-PCR)

  3. Changes in viral load from baseline to end of treatment - Time profile of viral load [ Time Frame: 28 days ]
    Viral load of SARS-CoV-2 RNA (# of viral copies) assessed by quantitative reverse transcription polymerase chain reaction (qRT-PCR)

  4. Changes in viral load from baseline to end of treatment - Percentage of patients that are viral negative [ Time Frame: 28 days ]
    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)

  5. Disease Recovery [ Time Frame: 28 days ]
    Disease recovery is defined as WHO Clinical Progression Scale score of ≤2

  6. Change in WHO Clinical Progression Scale score [ Time Frame: 28 days ]
    Change in score from baseline to day 28

  7. Incidence of all-cause mortality [ Time Frame: 30 days ]
    All-cause mortality calculated at Day 30

  8. Progression to supplementary oxygen requirement [ Time Frame: 14 days ]
    If the patient required supplementary oxygen during hospitalization

  9. Incidence of mechanical ventilation [ Time Frame: 14 days ]
    If the patient required mechanical ventilation during hospitalization

  10. Incidence of ICU admission [ Time Frame: 14 days ]
    If the patient was admitted to ICU

  11. Time to hospital discharge [ Time Frame: 29 days ]
    Length of time in hospital prior to being discharged

  12. Changes in serum C reactive protein levels (CRP) [ Time Frame: 29 days ]
    Changes in serum CRP levels

  13. Changes in D-dimer levels [ Time Frame: 29 days ]
    Changes in D-dimer levels

  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 [ Time Frame: 29 days ]
    Changes in sLDLR expression, and PCSK9 and sACE2 levels

  15. Changes in LDL-cholesterol [ Time Frame: 29 days ]
    Changes in LDL-cholesterol

  16. Changes in creatinine [ Time Frame: 29 days ]
    Changes in creatinine

  17. Changes in liver enzymes [ Time Frame: 29 days ]
    Changes in liver enzymes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04536090


Contacts
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Contact: Michel Chrétien, FRS MD FRCP© 1-833-705-0648 michel.chretien@ircm.qc.ca

Sponsors and Collaborators
Institut de Recherches Cliniques de Montreal
Pharmascience Inc.
SCiAN Services, Inc.
Quercis Pharma AG
Investigators
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Study Director: Michel Chrétien, FRS MD FRCP© Montreal Clinical Research Institute
Publications:
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Responsible Party: Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT04536090    
Other Study ID Numbers: IRCM-IQC-001
First Posted: September 2, 2020    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut de Recherches Cliniques de Montreal:
Isoquercetin
Quercetin
Antiviral Agents