Covid19Phase 2NCT04500418
Charité Trial of Cenicriviroc (CVC) Treatment for COVID-19 Patients
A Phase 2 study testing Cenicriviroc (CVC) in people with Covid19, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of this study is to test Cenicriviroc (CVC) as a means to reduce the severity of the lung disease COVID-19 caused by an infection with SARS-CoV-2. The safety of CVC, when administered to COVID-19 patients, will also be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Cenicriviroc (CVC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 25 Aug 2020to 27 Jul 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
- Subject provides written informed consent prior to initiation of any study procedures. Understands and agrees to comply with planned study procedures.
- Male or non-pregnant female adult ≥18 years of age at time of enrolment.
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR and fulfils the case criteria of COVID-19 (One or more of the following must be met in lieu of a positive PCR test: fever [defined as a temperature ≥ 100.0°F / 37.8°C documented within 24 hr. of randomization] , absolute and relative lymphopenia and leukopenia, new typical infiltrates in x-ray of the chest or chest CT scan [only if obtained for clinical reasons; not required by study], no improvement on antibiotics).
- Scoring a "3" or "4" (or "5", at the Investigator's discretion) on the 7-Point Ordinal Scale (see Outcome Measures) at enrolment. Note, if scoring a "2" at screening, inclusion will be met if the patient is in the process of being hospitalized or admitted to an inpatient setting. Such a patient would be assigned a "3" at enrolment for Baseline assessment purposes.
- No participation in other clinical trials according to the German Medicines Act (AMG) (3 months before) at the time of this trial.
Who cannot join
- ALT/AST > 5 times the upper limit of normal.
- Patients with severe hepatic impairment (defined as liver cirrhosis Child stage B or C)
- Stage 4 chronic kidney disease or requiring dialysis (i.e. eGFR < 30 ml/min)
- Advanced cardiac (eg, severe heart failure [NYHA III-IV]) or pulmonary diseases which, in the Investigator's judgment, would not make participation appropriate.
- Pregnancy or breast feeding.
- Anticipated transfer to another hospital which is not a study site within 72 hours.
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- Known allergy or hypersensitivity to CVC or its components.
- Use of medications that are contraindicated with CVC and that could not be replaced or stopped during the trial period
- Administration of specified drugs which interfere with the metabolism of CVC.
- Patients immediately or imminently requiring mechanical ventilation.
- Patients unwilling to consent to saving and propagation of pseudonymised medical data for study reasons.
- Subjects who are legally detained in an official institution.
- Subjects that are unsuitable to understand or to comply with the study requirements in the opinion of the investigator.
- Subjects who may be dependent on the sponsor, the investigator or the trial sites.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medical Department of Hepatology and Gastroenterology, Charité University Medicine, Campus Virchow Klinikum (CVK) and Campus Charité Mitte (CCM)
Berlin, 10117
About this study
The aim of this study is to test Cenicriviroc (CVC) as a means to reduce the severity of the lung disease COVID-19 caused by an infection with SARS-CoV-2. The safety of CVC, when administered to COVID-19 patients, will also be assessed. Furthermore, the clinical trial aims to answer the question of whether patients with pre-existing conditions, who have an increased risk of severe COVID-19 progression, benefit more and particularly from CVC. CVC is an orally available dual inhibitor of the chemokine receptors CCR2 and CCR5, which is expected to reduce (hyper-) inflammation in COVID-19.
The main goal of the study is to determine whether CVC helps increase the number of patients who are symptom-free and not hospitalized after 14 days compared to a placebo. Approximately 66.7% of the patients enrolled in the study will receive CVC and 33.3% will get an optically identical pill (placebo).
Subjects will be assessed daily while hospitalized. Discharged patients will be asked to attend study visits at Days 8, 15, 22, and 29 and 85. All subjects will undergo a series of clinical, safety, and laboratory assessments. Blood samples and oropharyngeal (OP) swabs will be obtained on Day 1; 3, 5 (while hospitalized); and Day 8, 15 and 29 (if able to return to clinic or still hospitalized). The presence of anti-SARS-CoV-2 antibodies will be determined on Days 29 and 85.
- Conditions
- Covid19
- Being tested
- Cenicriviroc (CVC), Placebo
- Keywords
- COVID-19, Cenicriviroc, CVC, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cenicriviroc (CVC)Drug
Also called Cenicriviroc Mesylate
Treatment with Cenicriviroc tablets of 150mg. (450g/300g on day 1 and 300mg/d on days 2-28).
PlaceboDrug
Optically identical pills without CVC.
| Study group | Role | What they receive |
|---|---|---|
| Cenicriviroc (CVC) | Active comparator | Approximately 122 patients. Day 1: CVC 450 mg (300 mg AM; 150 mg PM; if patients receive their first dose on Day 1 past 2 PM, then their evening dose will be 300 mg and their next dose will be the following AM.) Days 2-28: CVC BID 150 mg (AM/PM). Every dose should be taken with food (within 30 min). Receives: Drug: Cenicriviroc (CVC) |
| Placebo | Placebo comparator | Approximately 61 patients. A matching placebo will be given to the patients in the Placebo group at an equal volume and at the same schedule. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject´s Responder status (score on the 7-point ordinal scale on Day 15)
The Primary Endpoint will be the subject's responder status defined by achieving a score of "1" or "2" (discharged from hospital e.g.) on Day 15 on the following 7-point scale:
- Not hospitalized, no limitations on activities;
- Not hospitalized, limitation on activities;
- Hospitalized, not requiring supplemental oxygen;
- Hospitalized, requiring supplemental oxygen;
- Hospitalized, on non-invasive ventilation or high-flow oxygen devices;
- Hospitalized, on invasive mechanical ventilation or ECMO (Extracorporeal membrane oxygenation);
- Death.
Measured: 14 days after enrollment (Day 15)
Secondary outcomes (3)
Evaluation of change in clinical condition based on the 7-point ordinal scale
7-point ordinal scale to be assessed on Day 15 (and Day 1 for baseline comparison), analyses of
- ordinal change of 2 or more, compared with baseline
- ordinal change of 1 or more, compared with baseline
Measured: day of enrollment and 15 days after enrollment
Evaluation of change in clinical condition based on the 7-point ordinal scale and Responder Status
7-point ordinal scale assessed on: Days 8, 22, 29 (and Day 1 for baseline comparison), analyses of:
- Responder status (achieving a score of a "1" or a "2")
- ordinal change of 2 or more, compared with baseline
- ordinal change of 1 or more, compared with baseline
Measured: day of enrollment, 8 days, 22 days and 29 days after enrollment
Hospital resource utilization comparison
Analysis of:
- Length of time spent in the ICU (days)
- Length of time spent in the hospital (days)
- Days alive and out of hospital through Day 29
- Days free of endotracheal tube-based ventilation through Day 29
Measured: 29 days after enrollment, 85 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start25 Aug 2020
- Primary completion27 Jul 2021
- Study completion27 Jul 2021
Why it stopped: Despite multiple efforts, no further patient could be enrolled since 03/05/2021. A continuation of the study is therefore no longer justified
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Model description
- A monocentric, randomized, double-blind, placebo-controlled trial. Randomization will be stratified by: * Presence of baseline score of "3" on 7-point ordinal scale versus presence of baseline score of "4" or "5" on seven-point ordinal scale * Presence of one or more of the following comorbidities: Diabetes mellitus, Obesity (BMI \>30kg/m2), COPD or Asthma, Heart failure (NYHA Class I or II)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Prof. Dr. med. Frank Tacke, Charite University, Berlin, Germany
- Investigators
- Frank Tacke, Prof. Dr.med., Principal investigator, Charité University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500418
- Sponsor's protocol ID
- CVC for COVID-19
- Other IDs
- 2020-001493-29
- Status last verified
- Mar 2022
- First submitted
- 4 Aug 2020
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided at this moment. (08/2020)
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Charité Trial of Cenicriviroc (CVC) Treatment for COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04500418
- Acronym / sponsor ID
- CVC for COVID-19
- Conditions
- Covid19
- Keywords
- COVID-19, Cenicriviroc, CVC, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Despite multiple efforts, no further patient could be enrolled since 03/05/2021. A continuation of the study is therefore no longer justified
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 27 Jul 2021 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 5 Aug 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 aim of this study is to test Cenicriviroc (CVC) as a means to reduce the severity of the lung disease COVID-19 caused by an infection with SARS-CoV-2. The safety of CVC, when administered to COVID-19 patients, will also be assessed. Furthermore, the clinical trial aims to answer the question of whether patients with pre-existing conditions, who have an increased risk of severe COVID-19 progression, benefit more and particularly from CVC. CVC is an orally available dual inhibitor of the chemokine receptors CCR2 and CCR5, which is expected to reduce (hyper-) inflammation in COVID-19.
The main goal of the study is to determine whether CVC helps increase the number of patients who are symptom-free and not hospitalized after 14 days compared to a placebo. Approximately 66.7% of the patients enrolled in the study will receive CVC and 33.3% will get an optically identical pill (placebo).
Subjects will be assessed daily while hospitalized. Discharged patients will be asked to attend study visits at Days 8, 15, 22, and 29 and 85. All subjects will undergo a series of clinical, safety, and laboratory assessments. Blood samples and oropharyngeal (OP) swabs will be obtained on Day 1; 3, 5 (while hospitalized); and Day 8, 15 and 29 (if able to return to clinic or still hospitalized). The presence of anti-SARS-CoV-2 antibodies will be determined on Days 29 and 85.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A monocentric, randomized, double-blind, placebo-controlled trial. Randomization will be stratified by: * Presence of baseline score of "3" on 7-point ordinal scale versus presence of baseline score of "4" or "5" on seven-point ordinal scale * Presence of one or more of the following comorbidities: Diabetes mellitus, Obesity (BMI >30kg/m2), COPD or Asthma, Heart failure (NYHA Class I or II)
| Arm | Type | Receives |
|---|---|---|
| Cenicriviroc (CVC) | Active comparator | Drug: Cenicriviroc (CVC)Approximately 122 patients. Day 1: CVC 450 mg (300 mg AM; 150 mg PM; if patients receive their first dose on Day 1 past 2 PM, then their evening dose will be 300 mg and their next dose will be the following AM.) Days 2-28: CVC BID 150 mg (AM/PM). Every dose should be taken with food (within 30 min). |
| Placebo | Placebo comparator | Drug: PlaceboApproximately 61 patients. A matching placebo will be given to the patients in the Placebo group at an equal volume and at the same schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject provides written informed consent prior to initiation of any study procedures. Understands and agrees to comply with planned study procedures.
- Male or non-pregnant female adult ≥18 years of age at time of enrolment.
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR and fulfils the case criteria of COVID-19 (One or more of the following must be met in lieu of a positive PCR test: fever [defined as a temperature ≥ 100.0°F / 37.8°C documented within 24 hr. of randomization] , absolute and relative lymphopenia and leukopenia, new typical infiltrates in x-ray of the chest or chest CT scan [only if obtained for clinical reasons; not required by study], no improvement on antibiotics).
- Scoring a "3" or "4" (or "5", at the Investigator's discretion) on the 7-Point Ordinal Scale (see Outcome Measures) at enrolment. Note, if scoring a "2" at screening, inclusion will be met if the patient is in the process of being hospitalized or admitted to an inpatient setting. Such a patient would be assigned a "3" at enrolment for Baseline assessment purposes.
- No participation in other clinical trials according to the German Medicines Act (AMG) (3 months before) at the time of this trial.
Key exclusion criteria (14 listed)
- ALT/AST > 5 times the upper limit of normal.
- Patients with severe hepatic impairment (defined as liver cirrhosis Child stage B or C)
- Stage 4 chronic kidney disease or requiring dialysis (i.e. eGFR < 30 ml/min)
- Advanced cardiac (eg, severe heart failure [NYHA III-IV]) or pulmonary diseases which, in the Investigator's judgment, would not make participation appropriate.
- Pregnancy or breast feeding.
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 |
|---|---|---|
| Cenicriviroc (CVC)Also: Cenicriviroc MesylateTreatment with Cenicriviroc tablets of 150mg. (450g/300g on day 1 and 300mg/d on days 2-28). | Drug | Cenicriviroc (CVC) |
| PlaceboOptically identical pills without CVC. | Drug | Placebo |
Primary outcome
Subject´s Responder status (score on the 7-point ordinal scale on Day 15)
Time frame: 14 days after enrollment (Day 15)
The Primary Endpoint will be the subject's responder status defined by achieving a score of "1" or "2" (discharged from hospital e.g.) on Day 15 on the following 7-point scale: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or ECMO (Extracorporeal membrane oxygenation); 7. Death.
3 secondary outcomes
Evaluation of change in clinical condition based on the 7-point ordinal scale
Time frame: day of enrollment and 15 days after enrollment
Evaluation of change in clinical condition based on the 7-point ordinal scale and Responder Status
Time frame: day of enrollment, 8 days, 22 days and 29 days after enrollment
Hospital resource utilization comparison
Time frame: 29 days after enrollment, 85 days after enrollment
Results and safety
The study was stopped early (reason given: Despite multiple efforts, no further patient could be enrolled since 03/05/2021. A continuation of the study is therefore no longer justified). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: Undecided. Undecided at this moment. (08/2020)
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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.
Frank Tacke, Prof. Dr.med. principal investigator
Charité University, Berlin, Germany
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 Cenicriviroc (CVC) in people with Covid19, run by Charite University, Berlin, Germany at 1 site in Germany.
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 14 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 29 Mar 2022. 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 Germany. 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 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: Despite multiple efforts, no further patient could be enrolled since 03/05/2021. A continuation of the study is therefore no longer justified). 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?
Subject´s Responder status (score on the 7-point ordinal scale on Day 15) (time frame: 14 days after enrollment (Day 15)). 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 29 Mar 2022.