A Dose Escalation and Dose Expansion Study of NOX66 in the Treatment of COVID-19
- Registration Number
- NCT04555213
- Lead Sponsor
- Noxopharm Limited
- Brief Summary
Phase Ib, open-label, multicenter, study of NOX66, given rectally to hospitalized patients with moderate systemic illness due to COVID-19 infection at high risk of developing severe sepsis / septic shock.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- Hospitalized patient with clinically diagnosis of SARS-CoV-2 virus infection per World Health Organization criteria including positive nucleic acid test of any specimen (e.g., respiratory, blood, or other bodily fluid) within 2 weeks prior to screening.{Other confirmatory test results will be accepted upon approval from Sponsor/CRO Medical Monitor prior to enrolment}.
- Symptoms suggestive of moderate systemic illness with COVID-19, which could include any of the following symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath at rest, or respiratory distress.
- Clinical signs indicative of moderate systemic COVID-19 illness (with high risk of developing severe ARDS/septic shock) with an aggregate of NEWS-2 score of 4-6 or 3 in one single parameter.
Key
Patients who meet any of the following criteria will be disqualified from entering the study:
- Patients who require endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥ 0.5), non-invasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure.
- Presence of any of the following abnormal laboratory values at screening: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 x upper limit of normal (ULN), platelets <50,000/µL.
- Treatment with anti-IL 6, anti-IL-6R antagonists, or with Janus kinase inhibitors in the past 30 days or plans to receive during the study period.
- Current treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents.
- Use of chronic oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 10 mg or equivalent per day.
- History of, or current autoimmune or inflammatory systemic or localized disease(s) other than rheumatoid arthritis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation Cohort 3 - NOX66 800mg NOX66 NOX66 800 mg daily (400 mg suppository BID) Dos Escalation Cohort 2 - NOX66 600mg NOX66 NOX66 600 mg suppository OD Dose Expansion - NOX66 Recommended Phase 2 Dose NOX66 Dose Expansion: NOX66 RP2D Dose Escalation Cohort 1 - NOX66 400mg NOX66 NOX66 400 mg suppository OD Dose Escalation Cohort 4 - NOX66 1200mg NOX66 NOX66 1200 mg daily (600 mg suppository BID) Dose Escalation Cohort 5 - NOX66 1800mg NOX66 NOX66 1800 mg daily (600 mg suppository TID)
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events 60 Days Routine safety monitoring during the study period
- Secondary Outcome Measures
Name Time Method Change of National Early Warning Score 2 units from baseline 60 Days Measurement of 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness) to assess overall clinical condition.
Change in WHO-9 point ordinal scale 60 Days Assessment of WHO-9 point ordinal scale for clinical improvement (i.e., 0 = uninfected and 8 = death) category ordinal scale of clinical status from admission.
Trial Locations
- Locations (1)
Institute of Emergency Medicine
🇲🇩Chisinau, Moldova, Republic of