SPI-1005 Treatment in Severe COVID-19 Patients

Launched by SOUND PHARMACEUTICALS, INCORPORATED · Jul 21, 2020

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Eligibility 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
• • 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 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.