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

NCT ID: NCT04356508

Last Updated: 2020-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-14

Study Completion Date

2021-08-31

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention (n=10)

Nivolumab + best supportive care

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

Single dose at 0.3mg/kg

Non-intervention (n=5)

Best supportive care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nivolumab

Single dose at 0.3mg/kg

Intervention Type DRUG

Other Intervention Names

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Opdivo

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role collaborator

Dr Gerry Gin Wai Kwok

OTHER

Sponsor Role lead

Responsible Party

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Dr Gerry Gin Wai Kwok

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gerry Gin Wai Kwok, MBBS

Role: PRINCIPAL_INVESTIGATOR

Queen Mary Hospital, Hong Kong

Central Contacts

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Gerry Gin Wai Kwok, MBBS

Role: CONTACT

+852-22553111

Other Identifiers

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UW20213

Identifier Type: -

Identifier Source: org_study_id

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