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

Primary Purpose

COVID-19, SARS-CoV-2, 2019-nCoV

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Nivolumab
Sponsored by
Dr Gerry Gin Wai Kwok
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, SARS-CoV-2, 2019-nCoV, Coronavirus, Anti-PD1, Nivolumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention (n=10)

    Non-intervention (n=5)

    Arm Description

    Nivolumab + best supportive care

    Best supportive care

    Outcomes

    Primary Outcome Measures

    Viral clearance kinetics
    Viral load changes in NPS based on SARS-CoV-2 RT-PCR

    Secondary Outcome Measures

    Treatment-related adverse events of nivolumab (Intervention arm only)
    Incidence and severity of treatment-related adverse events
    Lymphocyte kinetics
    Changes in lymphocyte counts
    Cytokine kinetics
    Changes in cytokine levels (e.g. IL-1B, IL-2, IL-6, TNFa)
    Length of inpatient stay due to COVID-19

    Full Information

    First Posted
    April 10, 2020
    Last Updated
    April 17, 2020
    Sponsor
    Dr Gerry Gin Wai Kwok
    Collaborators
    The University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04356508
    Brief Title
    COVID-19: A Pilot Study of Adaptive Immunity and Anti-PD1
    Official Title
    COVID-19: A Pilot Study of Adaptive Immunity and Anti-PD1
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 14, 2020 (Anticipated)
    Primary Completion Date
    June 30, 2020 (Anticipated)
    Study Completion Date
    August 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dr Gerry Gin Wai Kwok
    Collaborators
    The University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19, SARS-CoV-2, 2019-nCoV, Pneumonia, Viral
    Keywords
    COVID-19, SARS-CoV-2, 2019-nCoV, Coronavirus, Anti-PD1, Nivolumab

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention (n=10)
    Arm Type
    Experimental
    Arm Description
    Nivolumab + best supportive care
    Arm Title
    Non-intervention (n=5)
    Arm Type
    No Intervention
    Arm Description
    Best supportive care
    Intervention Type
    Drug
    Intervention Name(s)
    Nivolumab
    Other Intervention Name(s)
    Opdivo
    Intervention Description
    Single dose at 0.3mg/kg
    Primary Outcome Measure Information:
    Title
    Viral clearance kinetics
    Description
    Viral load changes in NPS based on SARS-CoV-2 RT-PCR
    Time Frame
    From diagnosis to recovery, assessed up to 6 months
    Secondary Outcome Measure Information:
    Title
    Treatment-related adverse events of nivolumab (Intervention arm only)
    Description
    Incidence and severity of treatment-related adverse events
    Time Frame
    Up to 1 year after nivolumab dosing
    Title
    Lymphocyte kinetics
    Description
    Changes in lymphocyte counts
    Time Frame
    On days 1, 4, 6, 8, 10 and 28 from study enrollment
    Title
    Cytokine kinetics
    Description
    Changes in cytokine levels (e.g. IL-1B, IL-2, IL-6, TNFa)
    Time Frame
    On days 1, 4, 6, 8 and 10 from study enrollment
    Title
    Length of inpatient stay due to COVID-19
    Time Frame
    From hospital admission to discharge, assessed up to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gerry Gin Wai Kwok, MBBS
    Phone
    +852-22553111
    Email
    gggjerry@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gerry Gin Wai Kwok, MBBS
    Organizational Affiliation
    Queen Mary Hospital, Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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