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

NCT04555213 | Completed Phase 1 DMC

• 1 other identifier: NOX66-007
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Routine safety monitoring during the study period

  60 Days

Secondary Outcomes (2)

• Change of National Early Warning Score 2 units from baseline

  60 Days

• Change in WHO-9 point ordinal scale

  60 Days

Study Arms (6)

Dose Escalation Cohort 1 - NOX66 400mg

EXPERIMENTAL

NOX66 400 mg suppository OD

Drug: NOX66

Dos Escalation Cohort 2 - NOX66 600mg

EXPERIMENTAL

NOX66 600 mg suppository OD

Drug: NOX66

Dose Escalation Cohort 3 - NOX66 800mg

EXPERIMENTAL

NOX66 800 mg daily (400 mg suppository BID)

Drug: NOX66

Dose Escalation Cohort 4 - NOX66 1200mg

EXPERIMENTAL

NOX66 1200 mg daily (600 mg suppository BID)

Drug: NOX66

Dose Escalation Cohort 5 - NOX66 1800mg

EXPERIMENTAL

NOX66 1800 mg daily (600 mg suppository TID)

Drug: NOX66

Dose Expansion - NOX66 Recommended Phase 2 Dose

EXPERIMENTAL

Dose Expansion: NOX66 RP2D

Drug: NOX66

Interventions

NOX66 DRUG

NOX66 Suppository

Dos Escalation Cohort 2 - NOX66 600mg; Dose Escalation Cohort 1 - NOX66 400mg; Dose Escalation Cohort 3 - NOX66 800mg; Dose Escalation Cohort 4 - NOX66 1200mg; Dose Escalation Cohort 5 - NOX66 1800mg; Dose Expansion - NOX66 Recommended Phase 2 Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Noxopharm Limited: lead

Study Sites (1)

Institute of Emergency Medicine

Chisinau, Moldova

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gisela Mautner, MD, PhD

  Noxopharm Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 Dose Escalation: 400mg, 600mg, 800mg, 1200mg \& 1800mg Part 2 Dose Expansion : Recommended Phase 2 Dose

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 18, 2020
• Study Start: September 30, 2020
• Primary Completion: August 10, 2021
• Study Completion: August 10, 2021
• Last Updated: August 26, 2021

Record last verified: 2021-08

Locations

MO (1)