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

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: NOX66

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• Moldova, Republic of
  • Chisinau, Moldova, Republic of
    • Institute of Emergency Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation Cohort 1 - NOX66 400mg; NOX66 400 mg suppository OD	Drug: NOX66; NOX66 Suppository
Experimental: Dos Escalation Cohort 2 - NOX66 600mg; NOX66 600 mg suppository OD	Drug: NOX66; NOX66 Suppository
Experimental: Dose Escalation Cohort 3 - NOX66 800mg; NOX66 800 mg daily (400 mg suppository BID)	Drug: NOX66; NOX66 Suppository
Experimental: Dose Escalation Cohort 4 - NOX66 1200mg; NOX66 1200 mg daily (600 mg suppository BID)	Drug: NOX66; NOX66 Suppository
Experimental: Dose Escalation Cohort 5 - NOX66 1800mg; NOX66 1800 mg daily (600 mg suppository TID)	Drug: NOX66; NOX66 Suppository
Experimental: Dose Expansion - NOX66 Recommended Phase 2 Dose; Dose Expansion: NOX66 RP2D	Drug: NOX66; NOX66 Suppository

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	Routine safety monitoring during the study period	60 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of National Early Warning Score 2 units from baseline	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.	60 Days
Change in WHO-9 point ordinal scale	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.	60 Days

Collaborators and Investigators

• Sponsor: Noxopharm Limited
• Investigators: Study Director: Gisela Mautner, MD, PhD, Noxopharm Limited

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Actual): August 10, 2021
• Study Completion (Actual): August 10, 2021

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: NOX66-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No