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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04555213
Other study ID # NOX66-007
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 30, 2020
Est. completion date August 10, 2021

Study information

Verified date August 2021
Source Noxopharm Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date August 10, 2021
Est. primary completion date August 10, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
NOX66
NOX66 Suppository

Locations

Country Name City State
Moldova, Republic of Institute of Emergency Medicine Chisinau

Sponsors (1)

Lead Sponsor Collaborator
Noxopharm Limited

Country where clinical trial is conducted

Moldova, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-Emergent Adverse Events Routine safety monitoring during the study period 60 Days
Secondary 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
Secondary 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
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