SPI-1005 Treatment in Moderate COVID-19 Patients

Sponsor

Sound Pharmaceuticals, Incorporated (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04484025

Collaborator

(none)

Enrollment

Locations

Arms

11.6

Anticipated Duration (Months)

8.6

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 moderate symptoms of COVID-19 disease.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Corona Virus Infection Coronavirus Coronavirus Infection	Drug: Ebselen Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 12, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SPI-1005 400 mg BID Oral administration of SPI-1005 400 mg BID for 7 days, with 30-day follow-up	Drug: Ebselen Glutathione peroxidase mimetic Other Names: SPI-1005
Experimental: SPI-1005 800 mg BID Oral administration of SPI-1005 800 mg BID for 7 days, with 30-day follow-up	Drug: Ebselen Glutathione peroxidase mimetic Other Names: SPI-1005
Placebo Comparator: Placebo Oral administration of matching placebo BID for 7 days, with 30-day follow-up	Drug: Placebo Matching placebo containing excipients

Arm

Intervention/Treatment

Experimental: SPI-1005 400 mg BID

Oral administration of SPI-1005 400 mg BID for 7 days, with 30-day follow-up

Drug: Ebselen

Glutathione peroxidase mimetic

Other Names:

SPI-1005

Experimental: SPI-1005 800 mg BID

Oral administration of SPI-1005 800 mg BID for 7 days, with 30-day follow-up

Drug: Ebselen

Glutathione peroxidase mimetic

Other Names:

SPI-1005

Placebo Comparator: Placebo

Oral administration of matching placebo BID for 7 days, with 30-day follow-up

Drug: Placebo

Matching placebo containing excipients

Outcome Measures

Primary Outcome Measures

Number of participants with treatment-related adverse events [30 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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 moderate COVID-19
Score of 3-4 on the WHO Ordinal Scale
Onset of moderate COVID-19 symptoms ≤3 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University	New Haven	Connecticut	United States	06510
2	St. Luke's Cystic Fibrosis Center of Idaho	Boise	Idaho	United States	83702
3	Kansas University Medical Center	Kansas City	Kansas	United States	66160
4	Washington University in St. Louis	Saint Louis	Missouri	United States	63130
5	Duke University	Durham	North Carolina	United States	27710
6	Wake Forest University	Winston-Salem	North Carolina	United States	27109
7	University of Texas Southwestern	Dallas	Texas	United States	75390