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

April 17, 2020 updated by: Dr Gerry Gin Wai Kwok
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention (n=10)
Nivolumab + best supportive care
Drug: Nivolumab
Single dose at 0.3mg/kg
Other Names:
  • Opdivo
No Intervention: Non-intervention (n=5)
Best supportive care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: Up to 1 year after nivolumab dosing
Incidence and severity of treatment-related adverse events
Up to 1 year after nivolumab dosing
Lymphocyte kinetics
Time Frame: On days 1, 4, 6, 8, 10 and 28 from study enrollment
Changes in lymphocyte counts
On days 1, 4, 6, 8, 10 and 28 from study enrollment
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)
On days 1, 4, 6, 8 and 10 from study enrollment
Length of inpatient stay due to COVID-19
Time Frame: From hospital admission to discharge, assessed up to 6 months
From hospital admission to discharge, assessed up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Gerry Gin Wai Kwok

Collaborators

The University of Hong Kong

Investigators

  • Principal Investigator: Gerry Gin Wai Kwok, MBBS, Queen Mary Hospital, Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 14, 2020

Primary Completion (Anticipated)

June 30, 2020

Study Completion (Anticipated)

August 31, 2021

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

April 17, 2020

First Posted (Actual)

April 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 22, 2020

Last Update Submitted That Met QC Criteria

April 17, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW20213

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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