Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The University of Hong Kong | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (n=10) | Experimental | Nivolumab + best supportive care |
|
| Non-intervention (n=5) | No Intervention | Best supportive care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Single dose at 0.3mg/kg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Viral clearance kinetics | Viral load changes in NPS based on SARS-CoV-2 RT-PCR | From diagnosis to recovery, assessed up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related adverse events of nivolumab (Intervention arm only) | Incidence and severity of treatment-related adverse events | Up to 1 year after nivolumab dosing |
| Lymphocyte kinetics | Changes in lymphocyte counts |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerry Gin Wai Kwok, MBBS | Contact | +852-22553111 | gggjerry@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gerry Gin Wai Kwok, MBBS | Queen Mary Hospital, Hong Kong | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| On days 1, 4, 6, 8, 10 and 28 from study enrollment |
| 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 |
| Length of inpatient stay due to COVID-19 | From hospital admission to discharge, assessed up to 6 months |
| D003333 |
| Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |