COVID-19Phase 2NCT04575610
IRAK4 Inhibition in Treatment of COVID-19 With ARDS (I-RAMIC)
A Phase 2 study testing PF-06650833 in people with COVID-19, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy of PF-06650833 in addition to standard-of-care compared to standard-of-care treatment alone in improving outcomes in patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19
- What is being tested?
- PF-06650833
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2020to 6 Oct 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female patients, including women of childbearing potential, at least 18 years of age, inclusive
- Participant (or legally authorized representative) capable of giving signed informed consent
- Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection
- Clinical findings and an imaging study consistent with ARDS;
- PaO2 / FiO2 ratio < 300;
- A requirement for mechanical ventilation ≤ 48 hours prior to enrollment.
Show all 13Show fewer
- Evidence of increased inflammation as assessed by hsCRP > ULN AND at least ONE of the following being > upper limit of normal (as available):
- ferritin
- procalcitonin
- D-dimer
- fibrinogen
- LDH
- PT/PTT
Who cannot join
- Suspected or known active systemic bacterial, viral (except SARS-CoV2 infection), or fungal infections
- Active herpes zoster infection
- Known active or latent tuberculosis (TB) or history of inadequately treated TB
- Active hepatitis B or hepatitis C
- Known history of human immunodeficiency virus (HIV) infection with a detectable viral load or CD4 count < 500 cells / mm3 (patients for whom documented viral load or CD4 counts are available will be excluded)
- Active hematologic cancer
Show all 23Show fewer
- Metastatic or intractable cancer
- Pre-existing neurodegenerative disease
- Severe hepatic impairment defined as Child-Pugh Class B or Class C at baseline
- Severe renal impairment with an estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2
- Severe anemia (Hb < 8.0 g/dL)
- Any of the following abnormal laboratory values:
- absolute lymphocyte count <250 cells/mm3
- absolute neutrophil Count (ANC) <1000 cells/mm3
- Platelet count <50,000 cells/mm3
- ALT or AST > 5X ULN, or other evidence of hepatocellular synthetic dysfunction or total bilirubin > 2X ULN
- Any other medical condition or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
- Prohibited concomitant therapy (see section 1.12.7.2)
- Pregnancy (a negative urine or serum pregnancy test is required for inclusion)
- Immunocompromised patients, patients with known immunodeficiencies or taking potent immunosuppressive agents (e.g., azathioprine, cyclosporine)
- Anticipated survival < 72 hours as assessed by the Investigator.
- Participation in other clinical trials of investigational treatments for COVID-19
- Known history of nephrolithiasis
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: Investigation of IRAK4 Inhibition to Mitigate the Impact of COVID-19 in Severe SARS-CoV-2 (I-RAMIC)
The purpose of this study is to assess the efficacy of PF-06650833 in addition to standard-of-care compared to standard-of-care treatment alone in improving outcomes in patients with COVID-19.
Read the detailed description
Proposed is a randomized, double-blind, placebo-controlled, parallel group Phase 2 study of the efficacy and safety of PF-06650833, an investigational drug, in hospitalized adult male and female patients with SARS-CoV-2-induced ARDS who need mechanical ventilation.
The primary objective of this study is to assess the efficacy of PF-06650833 in addition to standard-of-care compared to standard-of-care treatment alone in improving outcomes in patients with COVID-19, evidence of increased inflammation, and ARDS requiring mechanical ventilation or extracorporeal membrane oxygenation at time of admission.
The secondary objectives of this study are to evaluate:
- Proportion of patients alive, extubated, and receiving no more that low flow oxygen supplementation by nasal cannula or face mask (excluding extubation for compassionate purposes in terminal patients). This would correspond to an at least 2-point improvement in the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale (1 = non hospitalized, no limitations on activity, and 8 = death) at Days 29 and 61
- Proportion of patients alive, extubated, and receiving any level oxygen supplementation, including non-invasive positive pressure ventilation or high flow oxygen device (excluding extubation for compassionate purposes in terminal patients). This would correspond to an at least 1-point improvement in the NIAID ordinal scale (1 = non hospitalized, no limitations on activity, and 8 = death) at Days 29 and 61
- Percentage of patients in each category of the NIAID 8-point ordinal scale of disease severity (Days 8, 15, 22, 29, and 61). The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows:
- Not hospitalized, no limitations on activities;
- Not hospitalized, limitation on activities and/or requiring home oxygen*
- Hospitalized, not requiring supplemental oxygen* - no longer requires ongoing medical care
- Hospitalized, not requiring supplemental oxygen* - requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalized, requiring supplemental oxygen*;
- Hospitalized, on non-invasive ventilation (NIV)** or high flow oxygen device;
- Hospitalized, on invasive mechanical ventilation or ECMO;
- Death
- For patients on chronic home O2 supplementation, supplemental O2 is defined as >= home O2 requirement.
- Use of NIV for chronic conditions [e.g. Obstructive sleep apnea (OSA)] is not applicable
- Mortality rate at Day 61
- Time to a 1-point improvement in the NIAID 8-point ordinal scale of disease severity
- Time to a 2-point improvement in the NIAID 8-point ordinal scale of disease severity
- Change from baseline in the ordinal scale from Day 1 to Days 3, 5, 8, 11, 15, 22, and
- Arterial partial pressure of oxygen (PaO2) / Fractional concentration of inspired oxygen (FiO2) ratio (or P/F ratio)
- Change of the Sequential Organ Failure Assessment (SOFA). The SOFA evaluates 6 variables, each representing an organ system (one for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems), and scored from 0 (normal) to 4 (high degree of dysfunction/failure). Thus, the maximum score may range from 0 to 24.
- Duration (days) of mechanical ventilation
- Ventilator free days
- Safety as assessed by reporting of adverse events (AEs), changes in clinical laboratory parameters (e.g., haemoglobin (Hb), white blood cell (WBC) count, platelets, hepatic transaminases, bilirubin, serum creatinine)
- Conditions
- COVID-19
- Being tested
- PF-06650833, Placebo
- Keywords
- Protein Kinase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06650833Drug
Subjects randomized to the PF-06650833 arm of the study will receive 200 mg IR suspension formulation every 6 hours (via nasogastric [NG] tube, orogastric [OG] tube, or equivalent) if unable to take tablets by mouth (PO). Subjects for whom concomitant administration of a strong inhibitor of cytochrome P450 (CYP) 3A4 will have the dose of the IR formulation to 200 mg once daily (QD). Subjects who can take tablets PO will receive 400 mg PF-06650833 (2-200 mg tablets) of the MR formulation QD under fasted conditions (preferably at least 4 hours after and 1.5 hours before a meal). No dose adjustment is needed for subjects taking the MR tablet preparation, except if co-administered with ritonavir in which case the dose should be reduced to 200 mg MR QD. All dosing of PF-06650833 will be in addition to current hospital SOC therapy.
PlaceboDrug
Matching placebo tablets will be administered.
| Study group | Role | What they receive |
|---|---|---|
| PF-06650833 + Standard of Care | Experimental | Subjects randomized to the PF-06650833 arm of the study will receive 200 mg IR suspension formulation every 6 hours (via nasogastric [NG] tube, orogastric [OG] tube, or equivalent) if unable to take tablets by mouth (PO). All dosing of PF-06650833 will be in addition to current hospital SOC therapy. Receives: Drug: PF-06650833 |
| Placebo + Standard of Care | Active comparator | Matching placebo tablets will be administered. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality at Day 29
All-cause mortality at Day 29 (end of planned treatment period).
Measured: Up to 29 days
Secondary outcomes (24)
Disease Severity (8 point scale)
Proportion of patients alive, extubated, and receiving no more than low flow oxygen supplementation by nasal cannula or face mask (excluding extubation for compassionate purposes in terminal patients). This would correspond to an at least 2 point decrease in the NIAID ordinal scale. The NIAID scale is as follows:
- Not hospitalized, no limitations on activities
- Not hospitalized, limitations on activities and/or requiring home oxygen
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
- Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalized, requiring supplemental oxygen
- Hospitalized, on non-invasive ventilation or high-flow oxygen devices
- Hospitalized, on invasive mechanical ventilation or ECMO
- Death
Measured: 29 days
Disease Severity (8 point scale)
Proportion of patients alive, extubated, and receiving no more than low flow oxygen supplementation by nasal cannula or face mask (excluding extubation for compassionate purposes in terminal patients). This would correspond to an at least 2 point decrease in the NIAID ordinal scale (1 = not hospitalized, no limitations on activities, and 8 = death) at Day 61.
Measured: 61 days
Disease Severity (8 point scale)
Proportion of patients alive, extubated, and receiving any level oxygen supplementation, including non-invasive positive pressure ventilation or high flow oxygen device (excluding extubation for compassionate purposes in terminal patients). This would correspond to an at least 1-point decrease in the NIAID ordinal scale (1 = not hospitalized, no limitations on activities, and 8 = death) at Day 29.
Measured: 29 days
Disease Severity (8 point scale)
Proportion of patients alive, extubated, and receiving any level oxygen supplementation, including non-invasive positive pressure ventilation or high flow oxygen device (excluding extubation for compassionate purposes in terminal patients). This would correspond to an at least 1-point decrease in the NIAID ordinal scale (1 = not hospitalized, no limitations on activities, and 8 = death) at Day 61.
Measured: 61 days
Disease Severity (8 point scale)
Percentage of patients in each category of the NIAID 8-point ordinal scale of disease severity at Day 8. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day in which 1 = not hospitalized, no limitations on activities, and 8 = death.
Measured: 8 days
Disease Severity (8 point scale)
Percentage of patients in each category of the NIAID 8-point ordinal scale of disease severity at Day 15. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day in which 1 = not hospitalized, no limitations on activities, and 8 = death.
Measured: 15 days
Disease Severity (8 point scale)
Percentage of patients in each category of the NIAID 8-point ordinal scale of disease severity at Day 22. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day in which 1 = not hospitalized, no limitations on activities, and 8 = death.
Measured: 22 days
Disease Severity (8 point scale)
Percentage of patients in each category of the NIAID 8-point ordinal scale of disease severity at Day 29. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day in which 1 = not hospitalized, no limitations on activities, and 8 = death.
Measured: 29 days
Disease Severity (8 point scale)
Percentage of patients in each category of the NIAID 8-point ordinal scale of disease severity at Day 61. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day in which 1 = not hospitalized, no limitations on activities, and 8 = death.
Measured: 61 days
Mortality
Mortality rate at day 61
Measured: 61 days
Disease Severity (8 point scale)
Time to a 1-point decrease in the NIAID 8-point ordinal scale of disease severity (1 = not hospitalized, no limitations on activities, and 8 = death).
Measured: 29 days
Disease Severity (8 point scale)
Time to a 2-point decrease in the NIAID 8-point ordinal scale of disease severity.
Measured: 29 days
Disease Severity (8 point scale)
Change from baseline in the ordinal scale from Day 1 to Days 3.
Measured: 3 days
Disease Severity (8 point scale)
Change from baseline in the ordinal scale from Day 1 to Days 5.
Measured: 5 days
Disease Severity (8 point scale)
Change from baseline in the ordinal scale from Day 1 to Days 8.
Measured: 8 days
Disease Severity (8 point scale)
Change from baseline in the ordinal scale from Day 1 to Days 11.
Measured: 11 days
Disease Severity (8 point scale)
Change from baseline in the ordinal scale from Day 1 to Days 15.
Measured: 15 days
Disease Severity (8 point scale)
Change from baseline in the ordinal scale from Day 1 to Days 22.
Measured: 22 days
Disease Severity (8 point scale)
Change from baseline in the ordinal scale from Day 1 to Days 29.
Measured: 29 days
P/F ratio
PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio)
Measured: Up to 29 days
Change of the SOFA score.
The SOFA evaluates 6 variables, each representing an organ system (one for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems), and scored from 0 (normal) to 4 (high degree of dysfunction/failure). Thus, the maximum score may range from 0 to 24.
Measured: Up to 29 days
Duration (days) of mechanical ventilation
The duration is days spent on mechanical ventilation.
Measured: Up to 29 days
Ventilator free days.
The number of days hospitalized not on a ventilator.
Measured: Up to 29 days
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Up to 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start27 Nov 2020
- Primary completion6 Oct 2021
- Study completion6 Oct 2021
Why it stopped: Study terminated due to lack of enrollment reflecting the decrease in number of COVID infections. There were no safety and/or efficacy concerns involved in the decision to stop enrollment.
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.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Hyung Chun, Yale University
- Investigators
- Hyung Chun, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575610
- Sponsor's protocol ID
- 2000028042
- Status last verified
- Oct 2021
- First submitted
- 5 Aug 2020
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of IRAK4 Inhibition to Mitigate the Impact of COVID-19 in Severe SARS-CoV-2 (I-RAMIC)
- ClinicalTrials.gov ID
- NCT04575610
- Acronym / sponsor ID
- 2000028042
- Conditions
- COVID-19
- Keywords
- Protein Kinase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to lack of enrollment reflecting the decrease in number of COVID infections. There were no safety and/or efficacy concerns involved in the decision to stop enrollment.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 6 Oct 2021 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 5 Oct 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.
The purpose of this study is to assess the efficacy of PF-06650833 in addition to standard-of-care compared to standard-of-care treatment alone in improving outcomes in patients with COVID-19.
Detailed description
Proposed is a randomized, double-blind, placebo-controlled, parallel group Phase 2 study of the efficacy and safety of PF-06650833, an investigational drug, in hospitalized adult male and female patients with SARS-CoV-2-induced ARDS who need mechanical ventilation.
The primary objective of this study is to assess the efficacy of PF-06650833 in addition to standard-of-care compared to standard-of-care treatment alone in improving outcomes in patients with COVID-19, evidence of increased inflammation, and ARDS requiring mechanical ventilation or extracorporeal membrane oxygenation at time of admission.
The secondary objectives of this study are to evaluate:
- Proportion of patients alive, extubated, and receiving no more that low flow oxygen supplementation by nasal cannula or face mask (excluding extubation for compassionate purposes in terminal patients). This would correspond to an at least 2-point improvement in the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale (1 = non hospitalized, no limitations on activity, and 8 = death) at Days 29 and 61
- Proportion of patients alive, extubated, and receiving any level oxygen supplementation, including non-invasive positive pressure ventilation or high flow oxygen device (excluding extubation for compassionate purposes in terminal patients). This would correspond to an at least 1-point improvement in the NIAID ordinal scale (1 = non hospitalized, no limitations on activity, and 8 = death) at Days 29 and 61
- Percentage of patients in each category of the NIAID 8-point ordinal scale of disease severity (Days 8, 15, 22, 29, and 61). The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows:
- Not hospitalized, no limitations on activities;
- Not hospitalized, limitation on activities and/or requiring home oxygen*
- Hospitalized, not requiring supplemental oxygen* - no longer requires ongoing medical care
- Hospitalized, not requiring supplemental oxygen* - requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalized, requiring supplemental oxygen*;
- Hospitalized, on non-invasive ventilation (NIV)** or high flow oxygen device;
- Hospitalized, on invasive mechanical ventilation or ECMO;
- Death
- For patients on chronic home O2 supplementation, supplemental O2 is defined as >= home O2 requirement.
- Use of NIV for chronic conditions [e.g. Obstructive sleep apnea (OSA)] is not applicable
- Mortality rate at Day 61
- Time to a 1-point improvement in the NIAID 8-point ordinal scale of disease severity
- Time to a 2-point improvement in the NIAID 8-point ordinal scale of disease severity
- Change from baseline in the ordinal scale from Day 1 to Days 3, 5, 8, 11, 15, 22, and
- Arterial partial pressure of oxygen (PaO2) / Fractional concentration of inspired oxygen (FiO2) ratio (or P/F ratio)
- Change of the Sequential Organ Failure Assessment (SOFA). The SOFA evaluates 6 variables, each representing an organ system (one for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems), and scored from 0 (normal) to 4 (high degree of dysfunction/failure). Thus, the maximum score may range from 0 to 24.
- Duration (days) of mechanical ventilation
- Ventilator free days
- Safety as assessed by reporting of adverse events (AEs), changes in clinical laboratory parameters (e.g., haemoglobin (Hb), white blood cell (WBC) count, platelets, hepatic transaminases, bilirubin, serum creatinine)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-06650833 + Standard of Care | Experimental | Drug: PF-06650833Subjects randomized to the PF-06650833 arm of the study will receive 200 mg IR suspension formulation every 6 hours (via nasogastric [NG] tube, orogastric [OG] tube, or equivalent) if unable to take tablets by mouth (PO). All dosing of PF-06650833 will be in addition to current hospital SOC therapy. |
| Placebo + Standard of Care | Active comparator | Drug: PlaceboMatching placebo tablets will be administered. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adult male and female patients, including women of childbearing potential, at least 18 years of age, inclusive
- Participant (or legally authorized representative) capable of giving signed informed consent
- Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection
- Clinical findings and an imaging study consistent with ARDS;
- PaO2 / FiO2 ratio < 300;
Key exclusion criteria (23 listed)
- Suspected or known active systemic bacterial, viral (except SARS-CoV2 infection), or fungal infections
- Active herpes zoster infection
- Known active or latent tuberculosis (TB) or history of inadequately treated TB
- Active hepatitis B or hepatitis C
- Known history of human immunodeficiency virus (HIV) infection with a detectable viral load or CD4 count < 500 cells / mm3 (patients for whom documented viral load or CD4 counts are available will be excluded)
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 |
|---|---|---|
| PF-06650833Subjects randomized to the PF-06650833 arm of the study will receive 200 mg IR suspension formulation every 6 hours (via nasogastric [NG] tube, orogastric [OG] tube, or equivalent) if unable to take tablets by mouth (PO). Subjects for whom concomitant administration of a strong inhibitor of cytochrome P450 (CYP) 3A4 will have the dose of the IR formulation to 200 mg once daily (QD). Subjects who can take tablets PO will receive 400 mg PF-06650833 (2-200 mg tablets) of the MR formulation QD under fasted conditions (preferably at least 4 hours after and 1.5 hours before a meal). No dose adjustment is needed for subjects taking the MR tablet preparation, except if co-administered with ritonavir in which case the dose should be reduced to 200 mg MR QD. All dosing of PF-06650833 will be in addition to current hospital SOC therapy. | Drug | PF-06650833 + Standard of Care |
| PlaceboMatching placebo tablets will be administered. | Drug | Placebo + Standard of Care |
Primary outcome
All-cause mortality at Day 29
Time frame: Up to 29 days
All-cause mortality at Day 29 (end of planned treatment period).
24 secondary outcomes
Disease Severity (8 point scale)
Time frame: 29 days
Disease Severity (8 point scale)
Time frame: 61 days
Disease Severity (8 point scale)
Time frame: 29 days
Disease Severity (8 point scale)
Time frame: 61 days
Disease Severity (8 point scale)
Time frame: 8 days
Disease Severity (8 point scale)
Time frame: 15 days
Disease Severity (8 point scale)
Time frame: 22 days
Disease Severity (8 point scale)
Time frame: 29 days
Disease Severity (8 point scale)
Time frame: 61 days
Mortality
Time frame: 61 days
Disease Severity (8 point scale)
Time frame: 29 days
Disease Severity (8 point scale)
Time frame: 29 days
Disease Severity (8 point scale)
Time frame: 3 days
Disease Severity (8 point scale)
Time frame: 5 days
Disease Severity (8 point scale)
Time frame: 8 days
Disease Severity (8 point scale)
Time frame: 11 days
Disease Severity (8 point scale)
Time frame: 15 days
Disease Severity (8 point scale)
Time frame: 22 days
Disease Severity (8 point scale)
Time frame: 29 days
P/F ratio
Time frame: Up to 29 days
Change of the SOFA score.
Time frame: Up to 29 days
Duration (days) of mechanical ventilation
Time frame: Up to 29 days
Ventilator free days.
Time frame: Up to 29 days
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Up to 29 days
Results and safety
The study was stopped early (reason given: Study terminated due to lack of enrollment reflecting the decrease in number of COVID infections. There were no safety and/or efficacy concerns involved in the decision to stop enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Hyung Chun, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-06650833 in people with COVID-19, run by Yale University at 1 site in United States.
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 13 inclusion and 23 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: stopped early, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Study terminated due to lack of enrollment reflecting the decrease in number of COVID infections. There were no safety and/or efficacy concerns involved in the decision to stop enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality at Day 29 (time frame: Up to 29 days). 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 26 Oct 2021.