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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Isoquercetin will be administered by mouth twice daily for 28 days
Disease Progression
Disease progression is defined as WHO Clinical Progression Scale ≥6, at any time between Day 1 and Day 28
Time frame: 28 days
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)
Time frame: 28 days
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)
Time frame: 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)
Time frame: 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)
Time frame: 28 days
Disease Recovery
Disease recovery is defined as WHO Clinical Progression Scale score of ≤2
Time frame: 28 days
Change in WHO Clinical Progression Scale score
Change in score from baseline to day 28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 28 days
Incidence of all-cause mortality
All-cause mortality calculated at Day 30
Time frame: 30 days
Progression to supplementary oxygen requirement
If the patient required supplementary oxygen during hospitalization
Time frame: 14 days
Incidence of mechanical ventilation
If the patient required mechanical ventilation during hospitalization
Time frame: 14 days
Incidence of ICU admission
If the patient was admitted to ICU
Time frame: 14 days
Time to hospital discharge
Length of time in hospital prior to being discharged
Time frame: 29 days
Changes in serum C reactive protein levels (CRP)
Changes in serum CRP levels
Time frame: 29 days
Changes in D-dimer levels
Changes in D-dimer levels
Time frame: 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
Time frame: 29 days
Changes in LDL-cholesterol
Changes in LDL-cholesterol
Time frame: 29 days
Changes in creatinine
Changes in creatinine
Time frame: 29 days
Changes in liver enzymes
Changes in liver enzymes
Time frame: 29 days