SPI-1005 Treatment in Severe COVID-19 Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Covid19, Coronavirus, Coronavirus Infection, Corona Virus Infection

In brief

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.

Key facts

Study ID

NCT04483973

Run by

Sound Pharmaceuticals, Incorporated

People needed

25

Starts

2021-08-27

Expected to finish

2023-06-06

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Yale University — New Haven, Connecticut, United States
• St. Luke's Cystic Fibrosis Center of Idaho — Boise, Idaho, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Duke University — Durham, North Carolina, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• University of Texas Southwestern — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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