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

Dr Gerry Gin Wai Kwok

Status and phase

Unknown

Phase 2

Conditions

COVID-19

2019-nCoV

Pneumonia, Viral

SARS-CoV-2

Treatments

Drug: Nivolumab

Study type

Interventional

Funder types

Other

Identifiers

NCT04356508

UW20213

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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