COVID-19Phase 2NCT04356508
COVID-19: A Pilot Study of Adaptive Immunity and Anti-PD1
A Phase 2 study testing Nivolumab in people with COVID-19 and SARS-CoV-2, run by Dr Gerry Gin Wai Kwok.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV-2, 2019-nCoV
- What is being tested?
- Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2020to 31 Aug 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Nivolumab
- Keywords
- COVID-19, SARS-CoV-2, 2019-nCoV, Coronavirus, Anti-PD1, Nivolumab
- Medical subject headings
- COVID-19, Pneumonia, Viral, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo
Single dose at 0.3mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Intervention (n=10) | Experimental | Nivolumab + best supportive care Receives: Drug: Nivolumab |
| Non-intervention (n=5) | No intervention | Best supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral clearance kinetics
Viral load changes in NPS based on SARS-CoV-2 RT-PCR
Measured: From diagnosis to recovery, assessed up to 6 months
Secondary outcomes (4)
Treatment-related adverse events of nivolumab (Intervention arm only)
Incidence and severity of treatment-related adverse events
Measured: Up to 1 year after nivolumab dosing
Lymphocyte kinetics
Changes in lymphocyte counts
Measured: 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)
Measured: On days 1, 4, 6, 8 and 10 from study enrollment
Length of inpatient stay due to COVID-19
Measured: From hospital admission to discharge, assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start14 Apr 2020 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Gerry Gin Wai Kwok
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong
- Responsible party
- Sponsor-investigator, Dr Gerry Gin Wai Kwok, Queen Mary Hospital, Hong Kong
- Investigators
- Gerry Gin Wai Kwok, MBBS, Principal investigator, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356508
- Sponsor's protocol ID
- UW20213
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19: A Pilot Study of Adaptive Immunity and Anti-PD1
- ClinicalTrials.gov ID
- NCT04356508
- Acronym / sponsor ID
- UW20213
- Conditions
- COVID-19, SARS-CoV-2, 2019-nCoV, Pneumonia, Viral
- Keywords
- COVID-19, SARS-CoV-2, 2019-nCoV, Coronavirus, Anti-PD1, Nivolumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Dr Gerry Gin Wai KwokUniversity, hospital or other
- Collaborators
- The University of Hong Kong
- Study start
- 14 Apr 2020 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (n=10) | Experimental | Drug: NivolumabNivolumab + best supportive care |
| Non-intervention (n=5) | No intervention | –Best supportive care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: OpdivoSingle dose at 0.3mg/kg | Drug | Intervention (n=10) |
Primary outcome
Viral clearance kinetics
Time frame: From diagnosis to recovery, assessed up to 6 months
Viral load changes in NPS based on SARS-CoV-2 RT-PCR
4 secondary outcomes
Treatment-related adverse events of nivolumab (Intervention arm only)
Time frame: Up to 1 year after nivolumab dosing
Lymphocyte kinetics
Time frame: On days 1, 4, 6, 8, 10 and 28 from study enrollment
Cytokine kinetics
Time frame: On days 1, 4, 6, 8 and 10 from study enrollment
Length of inpatient stay due to COVID-19
Time frame: From hospital admission to discharge, assessed up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerry Gin Wai Kwok, MBBS principal investigator
Queen Mary Hospital, Hong Kong
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab in people with COVID-19 and SARS-CoV-2, run by Dr Gerry Gin Wai Kwok.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerry Gin Wai Kwok, MBBS (+852-22553111, gggjerry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral clearance kinetics (time frame: From diagnosis to recovery, assessed up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.