Clinical trial NCT04555213: A Dose Escalation and Dose Expansion Study of NOX66 in the Treatment of COVID-19
Official title: A Dose Escalation and Dose Expansion Study of NOX66 in the Treatment of COVID-19 Infection (NOXCOVID)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Covid19
Lead sponsor: Noxopharm Limited
Sponsor class: INDUSTRY
First posted: 2020-09-18
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Part 1 Dose Escalation: 400mg, 600mg, 800mg, 1200mg \& 1800mg Part 2 Dose Expansion : Recommended Phase 2 Dose
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

1. 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}.
2. 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.
3. 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 Exclusion Criteria:

Patients who meet any of the following criteria will be disqualified from entering the study:

1. 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.
2. 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.
3. 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.
4. Current treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents.
5. Use of chronic oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 10 mg or equivalent per day.
6. History of, or current autoimmune or inflammatory systemic or localized disease(s) other than rheumatoid arthritis.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 60 Days
Secondary outcomes:
measure: Change of National Early Warning Score 2 units from baseline
timeFrame: 60 Days
measure: Change in WHO-9 point ordinal scale
timeFrame: 60 Days
Other outcomes:
Locations:
city: Chisinau
country: Moldova, Republic of
facility: Institute of Emergency Medicine
Study officials:
affiliation: Noxopharm Limited
name: Gisela Mautner, MD, PhD
role: STUDY_DIRECTOR
References: