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

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ClinicalTrials.gov Identifier: NCT04356508
Recruitment Status : Not yet recruiting
First Posted : April 22, 2020
Last Update Posted : April 22, 2020
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by (Responsible Party):
Dr Gerry Gin Wai Kwok, Queen Mary Hospital, Hong Kong

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.

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV-2 2019-nCoV Pneumonia, Viral Drug: Nivolumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COVID-19: A Pilot Study of Adaptive Immunity and Anti-PD1
Estimated Study Start Date : April 14, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Intervention (n=10)
Nivolumab + best supportive care
Drug: Nivolumab
Single dose at 0.3mg/kg
Other Name: Opdivo

No Intervention: Non-intervention (n=5)
Best supportive care



Primary Outcome Measures :
  1. Viral clearance kinetics [ Time Frame: From diagnosis to recovery, assessed up to 6 months ]
    Viral load changes in NPS based on SARS-CoV-2 RT-PCR


Secondary Outcome Measures :
  1. Treatment-related adverse events of nivolumab (Intervention arm only) [ Time Frame: Up to 1 year after nivolumab dosing ]
    Incidence and severity of treatment-related adverse events

  2. Lymphocyte kinetics [ Time Frame: On days 1, 4, 6, 8, 10 and 28 from study enrollment ]
    Changes in lymphocyte counts

  3. Cytokine kinetics [ Time Frame: On days 1, 4, 6, 8 and 10 from study enrollment ]
    Changes in cytokine levels (e.g. IL-1B, IL-2, IL-6, TNFa)

  4. Length of inpatient stay due to COVID-19 [ Time Frame: From hospital admission to discharge, assessed up to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04356508


Contacts
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Contact: Gerry Gin Wai Kwok, MBBS +852-22553111 gggjerry@gmail.com

Sponsors and Collaborators
Dr Gerry Gin Wai Kwok
The University of Hong Kong
Investigators
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Principal Investigator: Gerry Gin Wai Kwok, MBBS Queen Mary Hospital, Hong Kong
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Responsible Party: Dr Gerry Gin Wai Kwok, Doctor, Queen Mary Hospital, Hong Kong
ClinicalTrials.gov Identifier: NCT04356508    
Other Study ID Numbers: UW20213
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020

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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
Keywords provided by Dr Gerry Gin Wai Kwok, Queen Mary Hospital, Hong Kong:
COVID-19
SARS-CoV-2
2019-nCoV
Coronavirus
Anti-PD1
Nivolumab
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents