TerminatedNCT04734873Updated Sep 21, 2022Results posted

CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients

A Phase 3 interventional study of CPI-006 2 mg/kg + SOC and CPI-006 1 mg/kg + SOC in Covid-19, sponsored by Corvus Pharmaceuticals, Inc.. Terminated at 91 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-21.

Sponsored by Corvus Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment

Why this study was terminated

Sponsor decision. Not related to safety issues.

Phase: Phase 3
Study type: Interventional
Enrollment: 46
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 failure free between CPI-006 plus SOC versus placebo plus SOC.

Conditions studied

Covid-19

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Keywords

SARS-CoV-2
Covid
Coronavirus
Covid19
COVID-19

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 46 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Corvus Pharmaceuticals, Inc. is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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 for 6 weeks after study treatment administration

Exclusion criteria

Exclusion Criteria:

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 within 29 days of screening
Receipt of cancer chemotherapy or immunomodulatory drugs during preceding 2 months ( 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
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 or positive test for chronic infection or positive test for antibody
Pregnancy or breast feeding

Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 46 participants (actual)

Study arms

Experimental
CPI-006 (2 mg/kg) Plus Standard of Care
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.
Drug: CPI-006 2 mg/kg + SOC
Experimental
CPI-006 (1 mg/kg) Plus Standard of Care
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.
Drug: CPI-006 1 mg/kg + SOC
Placebo comparator
Placebo Plus Standard of Care
Participants will receive a single dose of placebo intravenously on Day 1 plus standard of care.
Drug: Placebo + SOC

Interventions

DrugCPI-006 2 mg/kg + SOC
Drug page: CPI-006
IV CPI-006 2 mg/kg up to a maximum dose of 200 mg plus standard of care
DrugCPI-006 1 mg/kg + SOC
Drug page: CPI-006
IV CPI-006 1 mg/kg up to a maximum dose of 100 mg plus standard of care
DrugPlacebo + SOC
IV placebo plus standard of care

What researchers measure

Primary outcomes

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.
Time frame: During the 28 days after dosing

Secondary outcomes

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.
Time frame: 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.
Time frame: 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
Time frame: During the 28 days after dosing

Results

Posted Aug 23, 2022

Limitations and caveats

The study was terminated due to enrollment difficulties and, as a result, some of the originally planned efficacy analyses could not be performed.

Participant flow

46 participants were screened and 42 were randomized. Of the 42 participants randomized, only 40 received the treatment assigned at randomization (2 were randomized but withdrew consent prior to receiving study treatment).

Participant flow — Overall Study
Milestone	Treatment A: CPI-006 2 mg/kg + SOC	Treatment B: CPI-006 1 mg/kg + SOC	Treatment C: Placebo + SOC
Started	16	14	12
Completed	14	11	9
Not completed	2	3	3
Withdrew: Lost to follow-up	1	3	2
Withdrew: Randomized but not dosed	1	0	1

Outcome measures

PrimaryProportion 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.

Time frame:: During the 28 days after dosing
Reported as:: Count of participants · Participants

Proportion of Participants Alive and Respiratory Failure Free of CPI-006 Plus SOC Versus Placebo Plus SOC
Participants	Treatment A: CPI-006 2 mg/kg + SOC	Treatment B: CPI-006 1 mg/kg + SOC	Treatment C: Placebo + SOC
Proportion of Participants Alive and Respiratory Failure Free of CPI-006 Plus SOC Versus Placebo Plus SOC	14	12	9

SecondaryTime 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.

Time frame:: During the 28 days after dosing
Reported as:: Median · days

Time to Recovery of CPI-006 Plus SOC Versus Placebo Plus SOC
days	Treatment A: CPI-006 2 mg/kg + SOC	Treatment B: CPI-006 1 mg/kg + SOC	Treatment C: Placebo + SOC
Time to Recovery of CPI-006 Plus SOC Versus Placebo Plus SOC	6.0 (4.0 to 9.0)	4.5 (3.0 to 8.0)	7.0 (2.0 to 12.0)

SecondaryTime 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.

Time frame:: During the 28 days after dosing
Reported as:: Median · days

Time to Clinical Improvement of CPI-006 Plus SOC Versus Placebo Plus SOC
days	Treatment A: CPI-006 2 mg/kg + SOC	Treatment B: CPI-006 1 mg/kg + SOC	Treatment C: Placebo + SOC
Time to Clinical Improvement of CPI-006 Plus SOC Versus Placebo Plus SOC	6.0 (4.0 to 9.0)	4.5 (3.0 to 8.0)	7.0 (2.0 to 12.0)

SecondaryMortality 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

Time frame:: During the 28 days after dosing
Reported as:: Count of participants · Participants

Mortality Rate Due to Any Cause of CPI-006 Plus SOC Versus Placebo Plus SOC
Participants	Treatment A: CPI-006 2 mg/kg + SOC	Treatment B: CPI-006 1 mg/kg + SOC	Treatment C: Placebo + SOC
Mortality Rate Due to Any Cause of CPI-006 Plus SOC Versus Placebo Plus SOC	0	0	0

Adverse events

Collected over From initiation of study treatment through study Day 28 (4 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Treatment A: CPI-006 2 mg/kg + SOC	0/15 (0%)	0/15 (0%)	5/15 (33.3%)
Treatment B: CPI-006 1 mg/kg + SOC	0/14 (0%)	0/14 (0%)	2/14 (14.3%)
Treatment C: Placebo + SOC	0/11 (0%)	2/11 (18.2%)	2/11 (18.2%)

Most frequent serious events

Most frequent serious events
Event	Treatment A: CPI-006 2 mg/kg + SOC	Treatment B: CPI-006 1 mg/kg + SOC	Treatment C: Placebo + SOC
Substance-induced psychotic disorderPsychiatric disorders	0/15	0/14	1/11
Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders	0/15	0/14	1/11

Most frequent other events

Showing 10 of 24

Most frequent other events
Event	Treatment A: CPI-006 2 mg/kg + SOC	Treatment B: CPI-006 1 mg/kg + SOC	Treatment C: Placebo + SOC
Visual impairmentEye disorders	0/15	0/14	1/11
Abdominal pain upperGastrointestinal disorders	0/15	0/14	1/11
HeadacheNervous system disorders	0/15	0/14	1/11
SyncopeNervous system disorders	0/15	0/14	1/11
MyopiaEye disorders	0/15	1/14	0/11
Dry mouthGastrointestinal disorders	0/15	1/14	0/11
Muscle spasmsMusculoskeletal and connective tissue disorders	0/15	1/14	0/11
HypoaesthesiaNervous system disorders	0/15	1/14	0/11
PresyncopeNervous system disorders	0/15	1/14	0/11
TremorNervous system disorders	0/15	1/14	0/11

Baseline characteristics

42 participants were randomized however only 40 received study treatment.

Age, Categorical
Age, Categorical(Participants)	Treatment A: CPI-006 2 mg/kg + SOC	Treatment B: CPI-006 1 mg/kg + SOC	Treatment C: Placebo + SOC	Total
<=18 years	0	0	0	0
Between 18 and 65 years	13	13	12	38
>=65 years	3	1	0	4

Age, Continuous
Age, Continuous(years)	Treatment A: CPI-006 2 mg/kg + SOC	Treatment B: CPI-006 1 mg/kg + SOC	Treatment C: Placebo + SOC	Total
Median	56.5 (28 to 69)	53.0 (25 to 67)	55.0 (21 to 63)	56.0 (21 to 69)

Sex: Female, Male
Sex: Female, Male(Participants)	Treatment A: CPI-006 2 mg/kg + SOC	Treatment B: CPI-006 1 mg/kg + SOC	Treatment C: Placebo + SOC	Total
Female	6	3	9	18
Male	10	11	3	24

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Treatment A: CPI-006 2 mg/kg + SOC	Treatment B: CPI-006 1 mg/kg + SOC	Treatment C: Placebo + SOC	Total
Hispanic or Latino	6	3	3	12
Not Hispanic or Latino	8	11	8	27
Unknown or Not Reported	2	0	1	3

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Treatment A: CPI-006 2 mg/kg + SOC	Treatment B: CPI-006 1 mg/kg + SOC	Treatment C: Placebo + SOC	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	1	1	2
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	2	2	2	6
White	13	11	9	33
More than one race	0	0	0	0
Unknown or Not Reported	1	0	0	1

Region of Enrollment
Region of Enrollment(Participants)	Treatment A: CPI-006 2 mg/kg + SOC	Treatment B: CPI-006 1 mg/kg + SOC	Treatment C: Placebo + SOC	Total
United States	16	13	12	41
Spain	0	1	0	1

8-point Ordinal Scale Assessment
8-point Ordinal Scale Assessment(Participants)	Treatment A: CPI-006 2 mg/kg + SOC	Treatment B: CPI-006 1 mg/kg + SOC	Treatment C: Placebo + SOC	Total
4	0	3	2	5
5	7	10	7	24
6	9	1	3	13

Study locations

91 sites

Sharp Chula Vista Medical Center
Chula Vista, California 91911, United States
El Centro Regional Medical Center
El Centro, California 92243, United States
Sharp Grossmont Hospital
La Mesa, California 91942, United States
Torrance Memorial Medical Center
Torrance, California 90505, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida 32224, United States
Cambridge Medical Trials
Alexandria, Louisiana 71301, United States
MedPharmics
Metairie, Louisiana 70006, United States
Holy Cross Hospital
Silver Spring, Maryland 20910, United States
Mayo Clinic - Rochester
Rochester, Minnesota 55905, United States
Stony Brook University Medical Center
Stony Brook, New York 11794, United States
Cape Fear Valley Medical Center
Fayetteville, North Carolina 28304, United States
Lehigh Valley Health Network
Allentown, Pennsylvania 18103, United States
Temple University Hospital
Philadelphia, Pennsylvania 19140, United States
Clinica Zabala
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Clínica Adventista Belgrano
Estomba, Buenos Aires, Argentina
Instituto Medico Platense
La Plata, Buenos Aires, Argentina
Clinica Independencia
Munro, Buenos Aires, Argentina
Instituto Médico Río Cuarto
Río Cuarto, Córdoba, Argentina
Centro de Investigación Clínica - Clínica Viedma
Viedma, Río Negro, Argentina
Centro Médico IPAM
Rosario, Santa Fe, Argentina
Hospital Provincial Del Centenario
Rosario, Santa Fe, Argentina
Clinica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, Tucumán, Argentina
Hospital de Clínicas Presidente Dr. Nicolás Avellaneda
San Miguel De Tucumán, Tucumán, Argentina
Fundación Sanatorio Güemes
Ciudad Autónoma de Buenos Aires, Argentina
Sanatorio Finochietto
Ciudad Autónoma de Buenos Aires, Argentina
Hospital Rawson
Córdoba, Argentina
Hospital Vera Cruz
Belo Horizonte, Minas Gerais, Brazil
Hospital Agamenon Magalhães
Recife, Pernambuco, Brazil
Santa Casa de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Dia do Pulmão
Blumenau, Santa Catarina, Brazil
Clínica Supera
Chapecó, Santa Catarina, Brazil
Centro Hospitalar Nossa Saúde
Curitiba, Brazil
Universidade Municipal São Caetano do Sul
São Caetano do Sul, Brazil
Conjunto Hospitalar do Mandaqui
São Paulo, Brazil
Hospital Anchieta
São Paulo, Brazil
Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto
São Paulo, Brazil
Hospital E Maternidade Celso Pierro PUCCAMP
São Paulo, Brazil
Universidade Federal Do Espirito Santo - Hospital Universitário Cassiano Antônio de Moraes - HUCAM
Vitória, Brazil
Toronto General Hospital
Toronto, Ontario, Canada
Hôpital Maisonneuve-Rosemont
Montréal, Quebec H1T 2M4, Canada
Hospital Base de Osorno
Concepción, Chile
Clinica Vespucio
La Florida, Chile
Research Network Consulting
Linares, Chile
Clínica Dávila Y Servicios Médicos SA
Santiago, Chile
Rodrigo Botero S.A.S
Medellín, Antioquia, Colombia
Fundacion Santa Fe de Bogota
Bogotá, Cundinamarca, Colombia
Clínica Universidad De la Sabana
Chía, Cundinamarca, Colombia
Fundacion Centro de Excelencia en Enfermedades Cronicas No Transmisibles
Monteria, Córdoba, Colombia
Clínica de la Mujer S.A.S.
Bogotá, Colombia
Hospital Universitario Clinica San Rafael
Bogotá, Colombia
Fundacion Hospitalaria San Vicente de Paul
Medellín, Colombia
Promotora Medica Las Américas S.A- Clínica Las Américas
Medellín, Colombia
Fundación Valle Del Lili
Santiago de Cali, Colombia
Medizinische Hochschule Hannover
Hannover, Niedersachsen, Germany
Azienda Ospedaliera Cotugno
Napoli, Campania, Italy
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
Milano, Lombardia, Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Milano, Lombardia, Italy
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
Milano, Lombardia, Italy
Ospedale San Raffaele S.r.l.
Milano, Lombardia, Italy
ASST di Monza - Azienda Ospedaliera San Gerardo
Monza, Lombardia, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombardia, Italy
ASST della Valle Olona - Azienda Ospedaliera Ospedale Di Circolo Di Busto Arsizio
Busto Arsizio, Italy
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Hospital Universitario Dr. Jose Eleuterio González
Monterrey, Nuevo Leon, Mexico
Hospital Civil de Culiacán
Culiacán, Sinaloa, Mexico
Hospital General de Culiacán
Culiacán, Sinaloa, Mexico
Hospital Nacional Sergio E. Bernales
Comas, Lima, Peru
Hospital Chancay y Servicios Basicos de Salud
Huaral, Lima, Peru
Hospital Central Fuerza Aérea del Perú
Miraflores, Lima, Peru
Hospital María Auxiliadora
San Juan De Miraflores, Lima, Peru
Clínica Providencia
San Miguel, Lima, Peru
Clínica San Pablo
Santiago De Surco, Lima, Peru
Hospital Alberto Sabogal Sologuren
Callao, Peru
Hospital Nacional Adolfo Guevara Velasco Essalud
Cusco, Peru
Hospital Militar Central
Lima, Peru
Hospital Nacional Guillermo Almenara Irigoyen
Lima, Peru
Hospital Costa del Sol
Marbella, Málaga, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarra, Spain
Hospital del Mar
Barcelona, Spain
Hospital General Universitario de Guadalajara
Guadalajara, Spain
Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca, Spain
Hospital Universitario A Coruña
Santiago de Compostela, Spain
Municipal Institution City Clinical Hospital #6 of Dnipropetrovsk Regional Council
Dnipro, Dnipropetrovs'ka Oblast, Ukraine
Kharkiv Regional Clinical Infectious Diseases Hospital
Kharkiv, Kharkivs'ka Oblast, Ukraine
Poltava Regional Clinical Infectious Hospital
Poltava, Poltavs'ka Oblast, Ukraine
Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
Vinnytsya, Vinnytsia Oblast, Ukraine
Municipal enterprise Volyn Regional Clinical Hospital of Volyn Regional Council
Lutsk, Volyn Oblast, Ukraine
MNPE City Hospital No. 6 of Zaporizhzhia City Council
Zaporizhzhia, Zaporiz'ka Oblast, Ukraine
Municipal Institution City Hospital #7
Zhaporizhzhya, Zaporiz'ka Oblast, Ukraine
CNPE City Clinical Hospital #3 of Chernivtsi City Council
Chernivtsi, Ukraine
Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council
Dnipro, Ukraine

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Mar 23, 2021

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2021 to primary completion in Aug 2021, 5 months.

Results were first posted in Aug 2022, 1 year after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 29, 2021
First posted: Feb 2, 2021
StartActual: Feb 25, 2021
Primary completionActual: Aug 18, 2021
CompletionActual: Aug 18, 2021
Results first posted: Aug 23, 2022
Last update: Sep 21, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04734873
Lead sponsor: Corvus Pharmaceuticals, Inc.
Responsible party: Sponsor
First posted: Feb 2, 2021
Start date: Feb 25, 2021
Primary completion: Aug 18, 2021
Completion: Aug 18, 2021
Results posted: Aug 23, 2022
Last update: Sep 21, 2022

Study contacts

S. Mahabhashyam, MD, MPH

study chair · Corvus Pharmaceuticals

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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