CancerPhase 2TITANNCT04447235
Early Treatment With Ivermectin and LosarTAN for Cancer Patients With COVID-19 Infection
A Phase 2 study testing Ivermectin and Losartan in people with Cancer and COVID, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
Ivermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of COVID-19 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, COVID, Coronavirus Infection
- What is being tested?
- Ivermectin and Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Jul 2020to 30 Jun 2022
- 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
- Age greater than or equal to 18 years of age
- Ability to understand and sign informed consent
- Biopsy-proven diagnosis of previous cancer (solid or hematologic disease)
- Participants must be diagnosed with active malignancy, defined as the presence of metastatic disease; or patient undergoing curative treatment during cancer treatment, regardless of the therapeutic modality.
- Confirmed diagnosis of COVID-19 by the presence of a positive PCR test or positive serological test and / or diagnosis presumed by the presence of flu-like symptoms associated to suggestive findings on CT scan.
- ECOG performance status 0 to 2
Show all 15Show fewer
- Patients must have an assessment of adequate organ function within 28 days prior to enrollment, evidenced by:
- Hemoglobin ≥ 9.0 g / dL
- Leukometry> 2,000 / mm3
- Absolute neutrophil count ≥ 1,500 / mm3
- Platelet count ≥ 100,000 / mm3
- Creatinine clearance ≥ 30 mL / min. Creatinine clearance (CrCl) should be calculated according to the Cockcroft-Gault formula.
- Total bilirubin <3 x the upper limit of normal (ULN), except for patients with known Gilbert's syndrome.
- Aspartate aminotransaminase (AST) <3.0 x LSN.
- Alanine aminotransaminase (ALT) <3.0 x ULN.
Who cannot join
- Currently taking an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin receptor blocker (ARB).
- Patients who presents with severe conditions at the time of diagnosis requiring ICU admission.
- Prior reaction or intolerance to an ARB or ACE inhibitor.
- Blood pressure less than 110/70 mmHg at presentation
- Potassium greater than 5.0 mEq / L
- Pregnancy or breastfeeding
- Prior reaction to Ivermectin.
- Patient currently enrolled in another research protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Doubled-blind Phase II Trial Evaluating the Use of Ivermectin Plus Losartan for Prophylaxis of Severe Events in Cancer Patients With Recent Diagnosis of COVID-19
Ivermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of COVID-19
Read the detailed description
This is a randomized, doubled-blind and placebo-controlled phase II study that will evaluate the efficacy of the early use of ivermectin plus losartan in cancer patients who present with recent diagnosis of COVID-19.
The trial will enroll 176 patients with previous diagnosis of active cancer (88 in each arm) and the aim of the study is to assess the efficacy of these drugs combination to decrease the incidence of COVID-19 severe complications. Patients will receive single dose ivermectin of 12mg after the confirmed diagnosis of COVID-19, followed by 15 days of losartan.
We believe that the association of anti-viral activity of the ivermectin plus the extracellular blockade of the receptor used by the virus will decrease the overall viremia and subsequently improve clinical outcomes.
- Conditions
- Cancer, COVID, Coronavirus Infection
- Being tested
- Placebo, Ivermectin, Losartan
- Keywords
- cancer, covid-19, losartan, ivermectin
- Medical subject headings
- Neoplasms, Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Use of the combination of ivermectin-placebo plus losartan-placebo as early treatment for COVID-19 in cancer patients
IvermectinDrug
Use of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients
LosartanDrug
Use of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients
| Study group | Role | What they receive |
|---|---|---|
| ARM A: Placebo | Placebo comparator | Patients will receive ivermectin-placebo single dose on the day of confirmed diagnosis of COVID-19, followed by losartan-placebo daily for 15 days. Receives: Drug: Placebo |
| ARM B: Ivermectin plus losartan | Experimental | Patients will receive a single dose of 12mg of ivermectin on the day of the confirmed diagnosis of COVID-19, followed by losartan 50mg orally once daily for 15 consecutive days Receives: Drug: Ivermectin; Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe complications due COVID-19 infection
Incidence of severe complications due COVID-19 infection defined as need for ICU admission, need for mechanical ventilation, or death
Measured: 28 days
Secondary outcomes (7)
Incidence of Severe Acute Respiratory Syndrome
Severe Acute Respiratory Syndrome defined as oxygen saturation less than 93%
Measured: 28 days
Incidence of Severe Acute Respiratory Syndrome
Severe Acute Respiratory Syndrome defined as respiratory rate higher than 24 incursion per minute
Measured: 28 days
Adverse events
Incidence of hepatic toxicity (elevation of ALT, AST above the upper limit of normal, measured by U/L)
Measured: 28 days
Adverse events
Incidence of hepatic toxicity (elevation of bilirubin above the upper limit of normal, measured by mg/dL)
Measured: 28 days
Adverse events
Incidence of renal toxicity (elevation of serum creatinine levels above the upper limit of normal, measured by mg/dL)
Measured: 28 days
Adverse events
Incidence of symptomatic postural hypotension, diagnosed by clinical assessment of reduction of > 20 mmHG of arterial systolic pressure after measurement in prone position and orthostatic position.
Measured: 28 days
Overall survival
Death of any cause since protocol enrollment
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start23 Jul 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Why it stopped: futility analysis has demonstrated no difference between arms
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedro Exman, MD, Principal investigator, Instituto do Cancer do Estado de São PauloMaria del Pilar Diz, MD, PhD, Study director, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447235
- Sponsor's protocol ID
- NP 1677/20
- Acronym
- TITAN
- Status last verified
- Aug 2022
- First submitted
- 22 Jun 2020
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Doubled-blind Phase II Trial Evaluating the Use of Ivermectin Plus Losartan for Prophylaxis of Severe Events in Cancer Patients With Recent Diagnosis of COVID-19
- ClinicalTrials.gov ID
- NCT04447235
- Acronym / sponsor ID
- TITAN / NP 1677/20
- Conditions
- Cancer, COVID, Coronavirus Infection
- Keywords
- cancer, covid-19, losartan, ivermectin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: futility analysis has demonstrated no difference between arms
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 25 Jun 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.
Ivermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of COVID-19
Detailed description
This is a randomized, doubled-blind and placebo-controlled phase II study that will evaluate the efficacy of the early use of ivermectin plus losartan in cancer patients who present with recent diagnosis of COVID-19.
The trial will enroll 176 patients with previous diagnosis of active cancer (88 in each arm) and the aim of the study is to assess the efficacy of these drugs combination to decrease the incidence of COVID-19 severe complications. Patients will receive single dose ivermectin of 12mg after the confirmed diagnosis of COVID-19, followed by 15 days of losartan.
We believe that the association of anti-viral activity of the ivermectin plus the extracellular blockade of the receptor used by the virus will decrease the overall viremia and subsequently improve clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A: Placebo | Placebo comparator | Drug: PlaceboPatients will receive ivermectin-placebo single dose on the day of confirmed diagnosis of COVID-19, followed by losartan-placebo daily for 15 days. |
| ARM B: Ivermectin plus losartan | Experimental | Drug: Ivermectin, Drug: LosartanPatients will receive a single dose of 12mg of ivermectin on the day of the confirmed diagnosis of COVID-19, followed by losartan 50mg orally once daily for 15 consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age greater than or equal to 18 years of age
- Ability to understand and sign informed consent
- Biopsy-proven diagnosis of previous cancer (solid or hematologic disease)
- Participants must be diagnosed with active malignancy, defined as the presence of metastatic disease; or patient undergoing curative treatment during cancer treatment, regardless of the therapeutic modality.
- Confirmed diagnosis of COVID-19 by the presence of a positive PCR test or positive serological test and / or diagnosis presumed by the presence of flu-like symptoms associated to suggestive findings on CT scan.
Key exclusion criteria (8 listed)
- Currently taking an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin receptor blocker (ARB).
- Patients who presents with severe conditions at the time of diagnosis requiring ICU admission.
- Prior reaction or intolerance to an ARB or ACE inhibitor.
- Blood pressure less than 110/70 mmHg at presentation
- Potassium greater than 5.0 mEq / L
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 |
|---|---|---|
| PlaceboUse of the combination of ivermectin-placebo plus losartan-placebo as early treatment for COVID-19 in cancer patients | Drug | ARM A: Placebo |
| IvermectinUse of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients | Drug | ARM B: Ivermectin plus losartan |
| LosartanUse of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients | Drug | ARM B: Ivermectin plus losartan |
Primary outcome
Incidence of severe complications due COVID-19 infection
Time frame: 28 days
Incidence of severe complications due COVID-19 infection defined as need for ICU admission, need for mechanical ventilation, or death
7 secondary outcomes
Incidence of Severe Acute Respiratory Syndrome
Time frame: 28 days
Incidence of Severe Acute Respiratory Syndrome
Time frame: 28 days
Adverse events
Time frame: 28 days
Adverse events
Time frame: 28 days
Adverse events
Time frame: 28 days
Adverse events
Time frame: 28 days
Overall survival
Time frame: 28 days
Results and safety
The study was stopped early (reason given: futility analysis has demonstrated no difference between arms). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: No. no plan to share individual participant data
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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.
Pedro Exman, MD principal investigator
Instituto do Cancer do Estado de São Paulo
Maria del Pilar Diz, MD, PhD study director
Instituto do Cancer do Estado de São Paulo
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 Ivermectin and Losartan in people with Cancer and COVID, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 15 inclusion and 8 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 9 Aug 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 Brazil. 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: futility analysis has demonstrated no difference between arms). 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?
Incidence of severe complications due COVID-19 infection (time frame: 28 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 9 Aug 2022.