Covid-19Phase 3NCT04734873
CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients
A Phase 3 study testing CPI-006 2 mg/kg + SOC and CPI-006 1 mg/kg + SOC in people with Covid-19, run by Corvus Pharmaceuticals, Inc. at 91 sites in 12 countries.
Trial summary
This is a phase 3, randomized, placebo controlled, double-blind, multicenter, stratified study of CPI-006 plus standard of care (SOC) versus placebo plus SOC in mild to moderately symptomatic hospitalized Covid-19 patients with the primary objective to compare the proportion of participants alive and respiratory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19
- What is being tested?
- CPI-006 2 mg/kg + SOC and CPI-006 1 mg/kg + SOC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 91 sitesin 12 countries
- Study dates
- 25 Feb 2021to 18 Aug 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Confirmed positive by polymerase chain reaction (PCR) or antigen test for SARS-CoV-2 with sample collection ≤ 10 days prior to randomization
- Covid-19 illness of any duration of symptoms
- Hospitalized for Covid-19 for ≤ 5 days with mild to moderate Covid-19 symptoms and meets criteria for either Category 4, Category 5, or Category 6 per 8-point ordinal scale
- Adequate organ function
- Participants of child-bearing age must agree to use adequate contraception for 6 weeks after study treatment administration
Who cannot join
- Signs of acute respiratory distress syndrome or respiratory failure necessitating mechanical ventilation at time of screening/randomization or anticipated need for mechanical ventilation
- History of severe chronic respiratory disease and requirement for long-term oxygen therapy
- Uncontrolled active systemic infection or hemodynamic instability requiring admission to an intensive care unit
- Malignant tumor receiving treatment, or other serious systemic diseases affecting life expectancy within 29 days of screening
- Receipt of cancer chemotherapy or immunomodulatory drugs during preceding 2 months (steroids for treatment of Covid-19 are acceptable)
- Convalescent plasma (CCP) or anti-SARS-CoV-2 monoclonal antibodies administered <24 hours prior to randomization. Must have recovered from any adverse events related to CCP treatment. Received chloroquine or hydroxychloroquine within last 7 days or during the study
Show all 12Show fewer
- Current participation in other clinical trials including extended access programs
- Active deep vein thrombosis or pulmonary embolism within last 6 months
- Anticipated discharge from hospital or transfer to another hospital which is not a study site within 48 hours of admission
- Active uncontrolled co-morbid disease that may interfere with study conduct or interpretation of findings
- Known to be positive for HIV or positive test for chronic HBV infection or positive test for hepatitis C antibody
- Pregnancy or breast feeding
Trial locations and contacts
91 sites in 12 countries.
91 sites in 12 countries
United States13 sites
Cambridge Medical Trials
Alexandria, Louisiana, 71301
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Sharp Chula Vista Medical Center
Chula Vista, California, 91911
El Centro Regional Medical Center
El Centro, California, 92243
Cape Fear Valley Medical Center
Fayetteville, North Carolina, 28304
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Sharp Grossmont Hospital
La Mesa, California, 91942
MedPharmics
Metairie, Louisiana, 70006
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Holy Cross Hospital
Silver Spring, Maryland, 20910
Stony Brook University Medical Center
Stony Brook, New York, 11794
Torrance Memorial Medical Center
Torrance, California, 90505
Argentina13 sites
Fundación Sanatorio Güemes
Buenos Aires
Sanatorio Finochietto
Buenos Aires
Clinica Zabala
Ciudad Autónoma de Buenos Aires, Buenos Aires
Hospital Rawson
Córdoba
Clínica Adventista Belgrano
Estomba, Buenos Aires
Instituto Medico Platense
La Plata, Buenos Aires
Clinica Independencia
Munro, Buenos Aires
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province
Centro Médico IPAM
Rosario, Santa Fe Province
Hospital Provincial Del Centenario
Rosario, Santa Fe Province
Clinica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, Tucumán Province
Hospital de Clínicas Presidente Dr. Nicolás Avellaneda
San Miguel de Tucumán, Tucumán Province
Centro de Investigación Clínica - Clínica Viedma
Viedma, Río Negro Province
Brazil12 sites
Hospital Vera Cruz
Belo Horizonte, Minas Gerais
Hospital Dia do Pulmão
Blumenau, Santa Catarina
Clínica Supera
Chapecó, Santa Catarina
Centro Hospitalar Nossa Saúde
Curitiba
Santa Casa de Porto Alegre
Porto Alegre, Rio Grande do Sul
Hospital Agamenon Magalhães
Recife, Pernambuco
Universidade Municipal São Caetano do Sul
São Caetano do Sul
Conjunto Hospitalar do Mandaqui
São Paulo
Hospital Anchieta
São Paulo
Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto
São Paulo
Hospital E Maternidade Celso Pierro PUCCAMP
São Paulo
Universidade Federal Do Espirito Santo - Hospital Universitário Cassiano Antônio de Moraes - HUCAM
Vitória
Peru10 sites
Hospital Alberto Sabogal Sologuren
Callao
Hospital Nacional Sergio E. Bernales
Comas, Lima region
Hospital Nacional Adolfo Guevara Velasco Essalud
Cusco
Hospital Chancay y Servicios Basicos de Salud
Huaral, Lima region
Hospital Militar Central
Lima
Hospital Nacional Guillermo Almenara Irigoyen
Lima
Hospital Central Fuerza Aérea del Perú
Miraflores, Lima region
Hospital María Auxiliadora
San Juan de Miraflores, Lima region
Clínica Providencia
San Miguel, Lima region
Clínica San Pablo
Santiago de Surco, Lima region
Colombia9 sites
Fundacion Santa Fe de Bogota
Bogotá, Cundinamarca
Clínica de la Mujer S.A.S.
Bogotá
Hospital Universitario Clinica San Rafael
Bogotá
Clínica Universidad De la Sabana
Chía, Cundinamarca
Rodrigo Botero S.A.S
Medellín, Antioquia
Fundacion Hospitalaria San Vicente de Paul
Medellín
Promotora Medica Las Américas S.A- Clínica Las Américas
Medellín
Fundacion Centro de Excelencia en Enfermedades Cronicas No Transmisibles
Montería, Departamento de Córdoba
Fundación Valle Del Lili
Santiago de Cali
Ukraine9 sites
CNPE City Clinical Hospital #3 of Chernivtsi City Council
Chernivtsi
Municipal Institution City Clinical Hospital #6 of Dnipropetrovsk Regional Council
Dnipro, Dnipropetrovsk Oblast
Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council
Dnipro
Kharkiv Regional Clinical Infectious Diseases Hospital
Kharkiv, Kharkiv Oblast
Municipal enterprise Volyn Regional Clinical Hospital of Volyn Regional Council
Lutsk, Volyn Oblast
Poltava Regional Clinical Infectious Hospital
Poltava, Poltava Oblast
Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
Vinnytsia, Vinnytsia Oblast
MNPE City Hospital No. 6 of Zaporizhzhia City Council
Zaporizhzhya, Zaporizhzhia Oblast
Municipal Institution City Hospital #7
Zhaporizhzhya, Zaporizhzhia Oblast
Italy8 sites
ASST della Valle Olona - Azienda Ospedaliera Ospedale Di Circolo Di Busto Arsizio
Busto Arsizio
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
Milan, Lombardy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Milan, Lombardy
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
Milan, Lombardy
Ospedale San Raffaele S.r.l.
Milan, Lombardy
ASST di Monza - Azienda Ospedaliera San Gerardo
Monza, Lombardy
Azienda Ospedaliera Cotugno
Naples, Campania
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombardy
Spain6 sites
Hospital del Mar
Barcelona
Hospital General Universitario de Guadalajara
Guadalajara
Hospital Costa del Sol
Marbella, Málaga
Complejo Hospitalario de Navarra
Pamplona, Navarre
Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca
Hospital Universitario A Coruña
Santiago de Compostela
Chile4 sites
Hospital Base de Osorno
Concepción
Clinica Vespucio
La Florida
Research Network Consulting
Linares
Clínica Dávila Y Servicios Médicos SA
Santiago
Mexico4 sites
Hospital Civil de Culiacán
Culiacán, Sinaloa
Hospital General de Culiacán
Culiacán, Sinaloa
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco
Hospital Universitario Dr. Jose Eleuterio González
Monterrey, Nuevo León
Canada2 sites
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Toronto General Hospital
Toronto, Ontario
About this study
Official title: Phase 3, Randomized, Placebo Controlled, Double-blind, Multicenter, Stratified Study of CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients
This is a phase 3, randomized, placebo controlled, double-blind, multicenter, stratified study of CPI-006 plus standard of care (SOC) versus placebo plus SOC in mild to moderately symptomatic hospitalized Covid-19 patients with the primary objective to compare the proportion of participants alive and respiratory failure free between CPI-006 plus SOC versus placebo plus SOC.
- Conditions
- Covid-19
- Being tested
- CPI-006 2 mg/kg + SOC, CPI-006 1 mg/kg + SOC, Placebo + SOC
- Keywords
- SARS-CoV-2, Covid, Coronavirus, Covid19, COVID-19
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPI-006 2 mg/kg + SOCDrug
IV CPI-006 2 mg/kg up to a maximum dose of 200 mg plus standard of care
CPI-006 1 mg/kg + SOCDrug
IV CPI-006 1 mg/kg up to a maximum dose of 100 mg plus standard of care
Placebo + SOCDrug
IV placebo plus standard of care
| Study group | Role | What they receive |
|---|---|---|
| CPI-006 (2 mg/kg) Plus Standard of Care | Experimental | Participants will receive a single dose of CPI-006 at 2 mg/kg up to a maximum dose of 200 mg intravenously on Day 1 plus standard of care. Receives: Drug: CPI-006 2 mg/kg + SOC |
| CPI-006 (1 mg/kg) Plus Standard of Care | Experimental | Participants will receive a single dose of CPI-006 at 1 mg/kg up to a maximum dose of 100 mg intravenously on Day 1 plus standard of care. Receives: Drug: CPI-006 1 mg/kg + SOC |
| Placebo Plus Standard of Care | Placebo comparator | Participants will receive a single dose of placebo intravenously on Day 1 plus standard of care. Receives: Drug: Placebo + SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Alive and Respiratory Failure Free of CPI-006 Plus SOC Versus Placebo Plus SOC
Proportion of participants who are alive and free from respiratory deterioration in each active arm compared to placebo arm as measured by the modified World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement in which: 1=Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requiring ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise); 5=Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 8=Death.
Measured: During the 28 days after dosing
Secondary outcomes (3)
Time to Recovery of CPI-006 Plus SOC Versus Placebo Plus SOC
Time to recovery after dosing in each active arm compared to placebo arm as measured by the modified WHO 8-point Ordinal Scale for Clinical Improvement in which: 1=Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requiring ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise); 5=Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 8=Death.
Measured: During the 28 days after dosing
Time to Clinical Improvement of CPI-006 Plus SOC Versus Placebo Plus SOC
Time to clinical improvement in each active arm compared to placebo arm as measured by the modified WHO 8-point Ordinal Scale for Clinical Improvement in which: 1=Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requiring ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise); 5=Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 8=Death. Clinical improvement is defined as ≥ 2 points improvement in the 8-point ordinal scale.
Measured: During the 28 days after dosing
Mortality Rate Due to Any Cause of CPI-006 Plus SOC Versus Placebo Plus SOC
Proportion of participants who died in each active arm compared to placebo arm
Measured: During the 28 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start25 Feb 2021
- Primary completion18 Aug 2021
- Study completion18 Aug 2021
Why it stopped: Sponsor decision. Not related to safety issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corvus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- S. Mahabhashyam, MD, MPH, Study chair, Corvus Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734873
- Sponsor's protocol ID
- CPI-006-003
- Status last verified
- Sep 2022
- First submitted
- 29 Jan 2021
- Last updated
- 21 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Randomized, Placebo Controlled, Double-blind, Multicenter, Stratified Study of CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients
- ClinicalTrials.gov ID
- NCT04734873
- Acronym / sponsor ID
- CPI-006-003
- Conditions
- Covid-19
- Keywords
- SARS-CoV-2, Covid, Coronavirus, Covid19, COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision. Not related to safety issues.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Corvus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 18 Aug 2021 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Posted 23 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 3, randomized, placebo controlled, double-blind, multicenter, stratified study of CPI-006 plus standard of care (SOC) versus placebo plus SOC in mild to moderately symptomatic hospitalized Covid-19 patients with the primary objective to compare the proportion of participants alive and respiratory failure free between CPI-006 plus SOC versus placebo plus SOC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPI-006 (2 mg/kg) Plus Standard of Care | Experimental | Drug: CPI-006 2 mg/kg + SOCParticipants will receive a single dose of CPI-006 at 2 mg/kg up to a maximum dose of 200 mg intravenously on Day 1 plus standard of care. |
| CPI-006 (1 mg/kg) Plus Standard of Care | Experimental | Drug: CPI-006 1 mg/kg + SOCParticipants will receive a single dose of CPI-006 at 1 mg/kg up to a maximum dose of 100 mg intravenously on Day 1 plus standard of care. |
| Placebo Plus Standard of Care | Placebo comparator | Drug: Placebo + SOCParticipants will receive a single dose of placebo intravenously on Day 1 plus standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed positive by polymerase chain reaction (PCR) or antigen test for SARS-CoV-2 with sample collection ≤ 10 days prior to randomization
- Covid-19 illness of any duration of symptoms
- Hospitalized for Covid-19 for ≤ 5 days with mild to moderate Covid-19 symptoms and meets criteria for either Category 4, Category 5, or Category 6 per 8-point ordinal scale
- Adequate organ function
- Participants of child-bearing age must agree to use adequate contraception for 6 weeks after study treatment administration
Key exclusion criteria (12 listed)
- Signs of acute respiratory distress syndrome or respiratory failure necessitating mechanical ventilation at time of screening/randomization or anticipated need for mechanical ventilation
- History of severe chronic respiratory disease and requirement for long-term oxygen therapy
- Uncontrolled active systemic infection or hemodynamic instability requiring admission to an intensive care unit
- Malignant tumor receiving treatment, or other serious systemic diseases affecting life expectancy within 29 days of screening
- Receipt of cancer chemotherapy or immunomodulatory drugs during preceding 2 months (steroids for treatment of Covid-19 are acceptable)
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 |
|---|---|---|
| CPI-006 2 mg/kg + SOCIV CPI-006 2 mg/kg up to a maximum dose of 200 mg plus standard of care | Drug | CPI-006 (2 mg/kg) Plus Standard of Care |
| CPI-006 1 mg/kg + SOCIV CPI-006 1 mg/kg up to a maximum dose of 100 mg plus standard of care | Drug | CPI-006 (1 mg/kg) Plus Standard of Care |
| Placebo + SOCIV placebo plus standard of care | Drug | Placebo Plus Standard of Care |
Primary outcome
Proportion of Participants Alive and Respiratory Failure Free of CPI-006 Plus SOC Versus Placebo Plus SOC
Time frame: During the 28 days after dosing
Proportion of participants who are alive and free from respiratory deterioration in each active arm compared to placebo arm as measured by the modified World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement in which: 1=Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requiring ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise); 5=Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 8=Death.
3 secondary outcomes
Time to Recovery of CPI-006 Plus SOC Versus Placebo Plus SOC
Time frame: During the 28 days after dosing
Time to Clinical Improvement of CPI-006 Plus SOC Versus Placebo Plus SOC
Time frame: During the 28 days after dosing
Mortality Rate Due to Any Cause of CPI-006 Plus SOC Versus Placebo Plus SOC
Time frame: During the 28 days after dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
S. Mahabhashyam, MD, MPH study chair
Corvus Pharmaceuticals
91 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CPI-006 2 mg/kg + SOC and CPI-006 1 mg/kg + SOC in people with Covid-19, run by Corvus Pharmaceuticals, Inc. at 91 sites in 12 countries.
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 5 inclusion and 12 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 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 91 sites in United States, Argentina, Brazil, Peru, Colombia and 7 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Participants Alive and Respiratory Failure Free of CPI-006 Plus SOC Versus Placebo Plus SOC (time frame: During the 28 days after dosing). 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 21 Sep 2022.