Status:
UNKNOWN
SPI-1005 Treatment in Severe COVID-19 Patients
Lead Sponsor:
Sound Pharmaceuticals, Incorporated
Conditions:
Covid19
Coronavirus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 se...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04483973
Start Date
August 27 2021
End Date
December 31 2023
Last Update
October 3 2023
Active Locations (7)
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1
Yale University
New Haven, Connecticut, United States, 96510
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
St Louis, Missouri, United States, 63130