COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04483973

Miriam Treggiari, MD;Haifan Lin, PhD

Jonathan Kil, info@soundpharma.com (PI email not reported)

2020-07-23

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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 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

- 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.

3

Sound Pharmaceuticals, Incorporated

18

100

United States

Severe disease at enrollment

6: Severe disease at enrollment

60

Number of participants with treatment-related adverse events

None

Phase 2

[{"arm_notes": "400 mg", "treatment_id": 437, "treatment_name": "Ebselen", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "800 mg", "treatment_id": 437, "treatment_name": "Ebselen", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]