SPI-1005 Treatment in Severe COVID-19 Patients

• Status: Enrolling by invitation
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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 severe symptoms of COVID-19 disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sound Pharmaceuticals, Incorporated
• Treatments: Ebselen

Criteria

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

• Severe disease: requiring mechanical ventilation or oxygen, a SpO2 ≤ 94% on room air, or tachypnoea (respiratory rate ≥ 24 breaths/min)

• Symptom onset ≤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

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.