A Dose Escalation and Dose Expansion Study of NOX66 in the Treatment of COVID-19 (NOXCOVID)

Noxopharm

Status and phase: Completed; Phase 1

Conditions: Covid19

Treatments: Drug: NOX66

Study type: Interventional

Funder types: Industry

Identifiers

NCT04555213

NOX66-007

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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41 participants in 6 patient groups

Dose Escalation Cohort 1 - NOX66 400mg

Experimental group

Description:

NOX66 400 mg suppository OD

Treatment:

Drug: NOX66

Dos Escalation Cohort 2 - NOX66 600mg

Experimental group

Description:

NOX66 600 mg suppository OD

Treatment:

Drug: NOX66

Dose Escalation Cohort 3 - NOX66 800mg

Experimental group

Description:

NOX66 800 mg daily (400 mg suppository BID)

Treatment:

Drug: NOX66

Dose Escalation Cohort 4 - NOX66 1200mg

Experimental group

Description:

NOX66 1200 mg daily (600 mg suppository BID)

Treatment:

Drug: NOX66

Dose Escalation Cohort 5 - NOX66 1800mg

Experimental group

Description:

NOX66 1800 mg daily (600 mg suppository TID)

Treatment:

Drug: NOX66

Dose Expansion - NOX66 Recommended Phase 2 Dose

Experimental group

Description:

Dose Expansion: NOX66 RP2D

Treatment:

Drug: NOX66