COVID-19: A Pilot Study of Adaptive Immunity and Anti-PD1

Study Overview
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Brief Summary
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This is an open-label, controlled, single-centre pilot study of nivolumab in adult patients with COVID-19. This clinical study aims to evaluate efficacy of anti-PD1 antibody in relation to viral clearance and its safety.

Official Title
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COVID-19: A Pilot Study of Adaptive Immunity and Anti-PD1

Conditions
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COVID-19, SARS-CoV-2, 2019-nCoV, Pneumonia, Viral

Intervention / Treatment
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* Drug: Nivolumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of COVID-19 by RT-PCR for SARS-CoV-2 Clinically stable with disease severity defined as mild or moderate (mild disease is defined as symptoms with or without lung infiltrates on chest X-Ray or CT imaging; moderate disease is defined as lung infiltrates with evidence of type 1 respiratory failure) Asymptomatic patients may be enrolled if patients have obvious radiographic changes on chest or CT radiography deemed to be related to COVID-19 Exclusion Criteria: Active cancer, rheumatological and autoimmune conditions Transplant recipients, or patients on active immunosuppressants Chronic organ impairment, or documented or suspected concomitant infections (including chronic viral hepatitis B and hepatitis C) other than SARS-CoV-2 Lactating mothers and women who are pregnant or intending to become pregnant Acute respiratory distress syndrome, evidence of myocardial injury, disseminated intravascular coagulopathy, organ failure, hemophagocytosis, shock, respiratory distress, or need for mechanical ventilation, AICU admission, or high flow oxygen therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (n=10)<br>Nivolumab + best supportive care | Drug: Nivolumab<br>* Single dose at 0.3mg/kg<br>* Other names: Opdivo;|
| No Intervention: Non-intervention (n=5)<br>Best supportive care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral clearance kinetics | Viral load changes in NPS based on SARS-CoV-2 RT-PCR | From diagnosis to recovery, assessed up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related adverse events of nivolumab (Intervention arm only) | Incidence and severity of treatment-related adverse events | Up to 1 year after nivolumab dosing | 
| Lymphocyte kinetics | Changes in lymphocyte counts | On days 1, 4, 6, 8, 10 and 28 from study enrollment | 
| Cytokine kinetics | Changes in cytokine levels (e.g. IL-1B, IL-2, IL-6, TNFa) | On days 1, 4, 6, 8 and 10 from study enrollment | 
| Length of inpatient stay due to COVID-19 |  | From hospital admission to discharge, assessed up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, SARS-CoV-2, 2019-nCoV, Coronavirus, Anti-PD1, Nivolumab