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

Phase 2

• Conditions: COVID-19; SARS-CoV-2; 2019-nCoV; Pneumonia, Viral
• Interventions: Drug: Nivolumab

• Registration Number: NCT04356508
• Lead Sponsor: Dr Gerry Gin Wai Kwok

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-10
• Study Start: 2020-04-14
• Study First Submitted QC: 2020-04-17
• Last Update Submitted: 2020-04-17
• Study First Posted: 2020-04-22
• Last Update Posted: 2020-04-22
• Primary Completion: 2020-06-30
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention (n=10)	Nivolumab	Nivolumab + best supportive care

Primary Outcome Measures

Name	Time	Method
Viral clearance kinetics	From diagnosis to recovery, assessed up to 6 months	Viral load changes in NPS based on SARS-CoV-2 RT-PCR

Secondary Outcome Measures

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