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

SPI-1005-291

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.

2021-10-12

2023-12-31

2023-12-31

Early phase I

60

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2023-10-03