SPI-1005 Treatment in Severe COVID-19 Patients

Study Overview
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Brief Summary
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The study is a randomized, double-blind, placebo-controlled, dose escalation, multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR test for novel SARS-CoV-2 (nCoV2) and severe symptoms of COVID-19 disease.

Official Title
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Efficacy of SPI-1005 in Severe COVID-19 Patients

Conditions
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Covid19, Coronavirus, Coronavirus Infection, Corona Virus Infection

Intervention / Treatment
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* Drug: Ebselen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥18 years of age Positive nCoV2 PCR test by nasopharyngeal, oral, saliva, or respiratory sample Clinical signs, symptoms, and respiratory status consistent with severe COVID-19 Score of 5-7 on the WHO Ordinal Scale Onset of severe COVID-19 symptoms ≤7 days of study enrollment Subject is in-patient at time of randomization to study treatment Subject or legally authorized representative is willing and able to provide informed consent, and agrees for subject to comply with planned study procedures including reproductive requirements Exclusion Criteria: Female patients who are pregnant or breastfeeding. Participation in another interventional investigational drug or device study concurrently or within 30 days prior to study consent. Patients with impaired hepatic or renal function. Subject has any other illness or condition that, in the opinion of the investigator, would prohibit the subject from participating.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPI-1005 400 mg BID<br>Oral administration of SPI-1005 400 mg BID for 14 days, with 30-day follow-up | Drug: Ebselen<br>* Glutathione peroxidase mimetic<br>* Other names: SPI-1005;|
| Experimental: SPI-1005 800 mg BID<br>Oral administration of SPI-1005 800 mg BID for 14 days, with 30-day follow-up | Drug: Ebselen<br>* Glutathione peroxidase mimetic<br>* Other names: SPI-1005;|
| Placebo Comparator: Placebo<br>Oral administration of matching placebo BID for 14 days, with 30-day follow-up | Drug: Placebo<br>* Matching placebo containing excipients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHO Ordinal Scale | Clinical outcome assessed by WHO Ordinal Scale for Clinical Improvement. Scale is 0-8 where higher score is worse outcome. | 30 days | 
| Degree of supplemental oxygen | Respiratory status assessed by degree of supplemental oxygen (e.g. mask oxygen, mechanical ventilation) | 30 days | 
| Peripheral Oxygen Saturation (SpO2) | Peripheral oxygen saturation measured by pulse oximetry | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ebselen, SPI-1005, COVID-19, Covid, SARS-COV-2, Mpro, main protease, PLpro, papain-like protease