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

Sponsor

Dr Gerry Gin Wai Kwok (Other)

Overall Status

Unknown status

CT.gov ID

NCT04356508

Collaborator

The University of Hong Kong (Other)

Enrollment

Arms

16.6

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 SARS-CoV-2 2019-nCoV Pneumonia, Viral	Drug: Nivolumab	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 14, 2020

Anticipated Primary Completion Date :

Jun 30, 2020

Anticipated Study Completion Date :

Aug 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Viral clearance kinetics [From diagnosis to recovery, assessed up to 6 months]
Viral load changes in NPS based on SARS-CoV-2 RT-PCR

Secondary Outcome Measures

Treatment-related adverse events of nivolumab (Intervention arm only) [Up to 1 year after nivolumab dosing]
Incidence and severity of treatment-related adverse events
Lymphocyte kinetics [On days 1, 4, 6, 8, 10 and 28 from study enrollment]
Changes in lymphocyte counts
Cytokine kinetics [On days 1, 4, 6, 8 and 10 from study enrollment]
Changes in cytokine levels (e.g. IL-1B, IL-2, IL-6, TNFa)
Length of inpatient stay due to COVID-19 [From hospital admission to discharge, assessed up to 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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