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| Name | Class |
|---|---|
| Pharmascience Inc. | INDUSTRY |
| SCiAN Services, Inc. | UNKNOWN |
| Quercis Pharma AG | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isoquercetin (IQC-950AN) | Drug | Isoquercetin will be administered by mouth twice daily for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease Progression | Disease progression is defined as WHO Clinical Progression Scale ≥6, at any time between Day 1 and Day 28 | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes in viral load from baseline to end of treatment - Area under the viral load vs. time profiles |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel Chrétien, FRS MD FRCP© | Montreal Clinical Research Institute | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32539990 | Background | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C016527 | isoquercitrin |
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Viral load of SARS-CoV-2 RNA (# of viral copies) assessed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) |
| 28 days |
| 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 |
| 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 |
| Disease Recovery | Disease recovery is defined as WHO Clinical Progression Scale score of ≤2 | 28 days |
| Change in WHO Clinical Progression Scale score | Change in score from baseline to day 28 | 28 days |
| Incidence of all-cause mortality | All-cause mortality calculated at Day 30 | 30 days |
| Progression to supplementary oxygen requirement | If the patient required supplementary oxygen during hospitalization | 14 days |
| Incidence of mechanical ventilation | If the patient required mechanical ventilation during hospitalization | 14 days |
| Incidence of ICU admission | If the patient was admitted to ICU | 14 days |
| Time to hospital discharge | Length of time in hospital prior to being discharged | 29 days |
| Changes in serum C reactive protein levels (CRP) | Changes in serum CRP levels | 29 days |
| Changes in D-dimer levels | Changes in D-dimer levels | 29 days |
| 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 |
| Changes in LDL-cholesterol | Changes in LDL-cholesterol | 29 days |
| Changes in creatinine | Changes in creatinine | 29 days |
| Changes in liver enzymes | Changes in liver enzymes | 29 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |