ClinicalTrials.Veeva

Menu

SPI-1005 Treatment in Moderate COVID-19 Patients

S

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

NCT04484025
SPI-1005-291

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 moderate 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 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

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 7 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 7 days, with 30-day follow-up
Treatment:
Drug: Ebselen
Placebo
Placebo Comparator group
Description:
Oral administration of matching placebo BID for 7 days, with 30-day follow-up
Treatment:
Drug: Placebo

Trial contacts and locations

7

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems