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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04356508
• Other study ID #: UW20213
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 14, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: April 2020
• Source: Queen Mary Hospital, Hong Kong
• Contact: Gerry Gin Wai Kwok, MBBS
• Phone: +852-22553111
• Email: gggjerry[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: August 31, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Nivolumab
Single dose at 0.3mg/kg

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dr Gerry Gin Wai Kwok	The University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral clearance kinetics	Viral load changes in NPS based on SARS-CoV-2 RT-PCR	From diagnosis to recovery, assessed up to 6 months
Secondary	Treatment-related adverse events of nivolumab (Intervention arm only)	Incidence and severity of treatment-related adverse events	Up to 1 year after nivolumab dosing
Secondary	Lymphocyte kinetics	Changes in lymphocyte counts	On days 1, 4, 6, 8, 10 and 28 from study enrollment
Secondary	Cytokine kinetics	Changes in cytokine levels (e.g. IL-1B, IL-2, IL-6, TNFa)	On days 1, 4, 6, 8 and 10 from study enrollment
Secondary	Length of inpatient stay due to COVID-19		From hospital admission to discharge, assessed up to 6 months