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

• Status: Not yet recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr Gerry Gin Wai Kwok
• Collaborator: The University of Hong Kong
• Treatments: Nivolumab

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