SPI-1005 Treatment in Moderate COVID-19 Patients

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Efficacy of SPI-1005 in Moderate COVID-19 Patients

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 moderate symptoms of COVID-19 disease.

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 moderate COVID-19
• Score of 3-4 on the WHO Ordinal Scale
• Onset of moderate COVID-19 symptoms ≤3 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.