SPI-1005 Treatment in Severe COVID-19 Patients

Sound Pharmaceuticals

Status and phase: Invitation-only; Phase 2

Conditions: Corona Virus Infection; Covid19; Coronavirus Infection; Coronavirus

Treatments: Drug: Ebselen; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04483973

SPI-1005-292

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

SPI-1005 400 mg BID

Experimental group

Description:

Oral administration of SPI-1005 400 mg BID for 14 days, with 30-day follow-up

Treatment:

Drug: Ebselen

SPI-1005 800 mg BID

Experimental group

Description:

Oral administration of SPI-1005 800 mg BID for 14 days, with 30-day follow-up

Treatment:

Drug: Ebselen

Placebo

Placebo Comparator group

Description:

Oral administration of matching placebo BID for 14 days, with 30-day follow-up

Treatment:

Drug: Placebo