2019-nCoV, COVID-19, Pneumonia, Viral, SARS-CoV-2
Conditions
Keywords
COVID-19, SARS-CoV-2, 2019-nCoV, Coronavirus, Anti-PD1, Nivolumab
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.
Interventions
DRUGNivolumab
Single dose at 0.3mg/kg
Sponsors
The University of Hong Kong
Dr Gerry Gin Wai Kwok
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Contacts
Primary ContactGerry Gin Wai Kwok, MBBS
Outcome results
None listed