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

NCT04356508 | Unknown Phase 2 FDA Drug

• 1 other identifier: UW20213
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

COVID-19; SARS-CoV-2; 2019-nCoV; Coronavirus; Anti-PD1; Nivolumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Treatment-related adverse events of nivolumab (Intervention arm only)

  Up to 1 year after nivolumab dosing

• Lymphocyte kinetics

  On days 1, 4, 6, 8, 10 and 28 from study enrollment

• Cytokine kinetics

  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

Study Arms (2)

Intervention (n=10)

EXPERIMENTAL

Nivolumab + best supportive care

Drug: Nivolumab

Non-intervention (n=5)

NO INTERVENTION

Best supportive care

Interventions

Nivolumab DRUG

Single dose at 0.3mg/kg

Also known as: Opdivo

Intervention (n=10)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Gerry Gin Wai Kwok: lead
• The University of Hong Kong: collaborator

MeSH Terms

Conditions

COVID-19; Pneumonia, Viral; Coronavirus Infections

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Gerry Gin Wai Kwok, MBBS

  Queen Mary Hospital, Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerry Gin Wai Kwok, MBBS

CONTACT

+852-22553111; gggjerry@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 22, 2020
• Study Start: April 14, 2020
• Primary Completion: June 30, 2020
• Study Completion: August 31, 2021
• Last Updated: April 22, 2020

Record last verified: 2020-04